Podcasts about lutetium

FDA expands approvals for durvalumab (bladder cancer) and Lutetium-177 vipivotide tetraxetan (pre-taxane in metastatic prostate cancer). Portland has places.

Mehr Geld, mehr Urlaub, mehr Piccolo. Trump eint den Rest der Welt - gegen sich. Was F47-Bomber und Nvidia-Chips mit seltenen Erden zu tun haben. Bühnenangst und Pottasche. Gut gelaunt präsentieren Paul und Hajo Schumacher die fangfrische Wochenschau aus den Schöneberger Hinterhofstudios, mit diesen Themen: Zölle gegen Steuergeschenke. Frühling und Krähendurchfall. Unfug mit dem BMI. Strategiepolitik, Inhaltspolitik und die Lehren des italienischen Fußballs. Bereitwillig untergehen im Nachrichtenmeer. Seltene Erden und rare Tulpen. Muß Lars Klingbeil seinen Duzfreund Friedrich retten? Warum die Sentinelesen keine Cola wollen. Ist der große Borstenwurm illegal nach Karlsruhe eingewandert? Dient Mileis Kettensägenwart Stürzenegger Elon Musk als Vorbild? Udo Butter vor Welttournee. Plus: Krimi-Team Achilles sucht Läufer für Staffel beim Berlin-Triathlon. Folge 923.Literaturempfehlungen: Michael Meisheit + Hajo Schumacher Lügen haben schnelle Beine: Laufende Ermittlungen - Band 2 Droemer Verlag, 2025Suse SchumacherDie Psychologie des Waldes, Kailash Verlag, 2024Michael Meisheit + Hajo Schumacher Nur der Tod ist schneller – Laufende Ermittlungen, Kriminalroman, Droemer Knaur Verlag.Kathrin Hinrichs + Hajo SchumacherBuch: "Ich frage für einen Freund..." Das Sex-ABC für Spaß in den besten JahrenKlartext Verlag.Kostenlose Meditationen für mehr Freundlichkeit (Metta) und Gelassenheit (Reise zum guten Ort) unter suseschumacher.deDem MutMachPodcast auf Instagram folgen Hosted on Acast. See acast.com/privacy for more information.

Join us in this insightful episode of the Oncology Brothers podcast as we dive deep into the current treatment landscape of prostate cancer with Dr. Alan Bryce, Chief Clinical Officer and GU Medical Oncologist from City of Hope. In this episode, we explore: •⁠  ⁠The treatment paradigm for early-stage prostate cancer, including the role of active surveillance and the use of abiraterone based on the STAMPEDE trial. •⁠  ⁠The importance of understanding risk factors and treatment options for low, intermediate, and high-risk patients. •⁠  ⁠The implications of PET-PSMA imaging versus conventional CT modalities in staging and treatment decisions. •⁠  ⁠The management of biochemical recurrent disease and the significance of PSA doubling time in treatment planning. •⁠  ⁠The role of PARP inhibitors in patients with HRR mutations and the nuances of selecting appropriate therapies. •⁠  ⁠Strategies for managing metastatic disease, including the use of Lutetium-177 (Pluvicto) and cabazitaxel. Dr. Bryce provides a masterclass on navigating the complexities of prostate cancer treatment, emphasizing the need to balance between over-treatment in early disease and under-treatment in metastatic cases. YouTube: https://youtu.be/Zfu-yGmH0rg Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ If you find this episode helpful, please share it with your colleagues and leave us a review! Don't forget to check out our other episodes in the GU treatment algorithm series, including discussions on renal cell carcinoma and bladder cancer.

MILANO (ITALPRESS) - Al via un nuovo trattamento innovativo per la cura del carcinoma prostatico metastatico resistente alla castrazione. Si tratta della terapia con radioligandi Lutetium, per cui l'Agenzia Italiana del Farmaco ha approvato l'ammissione alla rimborsabilità. Dopo la pubblicazione in Gazzetta Ufficiale lo scorso 3 marzo, la nuova terapia sarà disponibile nelle singole regioni non appena saranno conclusi gli iter regionali. Questo traguardo rende accessibile ai pazienti affetti da carcinoma prostatico metastatico PSMA positivo la prima terapia con radioligandi, un'innovazione della medicina di precisione basata sulla teragnostica che unisce fase diagnostica e fase terapeutica in un approccio che consente di colpire in modo mirato le cellule tumorali, migliorando conseguentemente l'efficacia del trattamento e la tollerabilità per i pazienti.xm4/mgg/gtr

MILANO (ITALPRESS) - Al via un nuovo trattamento innovativo per la cura del carcinoma prostatico metastatico resistente alla castrazione. Si tratta della terapia con radioligandi Lutetium, per cui l'Agenzia Italiana del Farmaco ha approvato l'ammissione alla rimborsabilità. Dopo la pubblicazione in Gazzetta Ufficiale lo scorso 3 marzo, la nuova terapia sarà disponibile nelle singole regioni non appena saranno conclusi gli iter regionali. Questo traguardo rende accessibile ai pazienti affetti da carcinoma prostatico metastatico PSMA positivo la prima terapia con radioligandi, un'innovazione della medicina di precisione basata sulla teragnostica che unisce fase diagnostica e fase terapeutica in un approccio che consente di colpire in modo mirato le cellule tumorali, migliorando conseguentemente l'efficacia del trattamento e la tollerabilità per i pazienti.xm4/mgg/gtr

Guest: Alan Bryce, MD Lutetium-177and radium-223 have both been shown to significantly improve survival in patients with metastatic castration-resistant prostate cancer, but how do these treatment options compare? Find out with Dr. Alan Bryce, who presented a session on this exact topic at the 2024 ASCO Genitourinary Cancers Symposium.

This week on BackTable Urology, urologic oncologist Dr. Bogdana Schmidt (University of Utah) hosts a discussion with medical oncology experts Dr. Rana McKay (UC San Diego) and Dr. Neeraj Agarwal (University of Utah) on recent clinical trials from bladder, kidney, and prostate cancer research presented at the 2023 European Society for Medical Oncology (ESMO) Meeting. First, they discuss impactful data regarding bladder cancers, specifically the CheckMate 901 and the EV-302 trials which show improvement in overall survival and promise for urothelial carcinoma patients' quality of life. The conversation moves onto kidney-specific trials such as the LITESPARK-005, which offers improved progression-free survival for patients through the use of belzutifan. The panel rounds off by discussing the progress made in prostate-specific trials with emphasis on the EMBARK and SPLASH trials involving Lutetium therapy. Finally, the doctors discuss the trend towards personalized treatment plans based on the unique goals and health requirements of the patients. --- SHOW NOTES 00:00 - Discussion on Urothelial Carcinoma: CheckMate 901 and EV-302 11:22 - Discussion on Kidney Cancer: LITESPARK-005 23:53 - Discussion on Prostate Cancer: EMBARK 31:41 - Discussion on Prostate Cancer: SPLASH vs PSMA 36:39 - Future Directions for Lutetium Therapy for Prostate Cancer 37:50 - Closing Remarks and Future Expectations --- RESOURCES CheckMate 901 Trial Investigators. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. https://www.nejm.org/doi/full/10.1056/NEJMoa2309863 LBA6 EV-302/KEYNOTE-A39: Open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (Chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). https://www.sciencedirect.com/science/article/pii/S0923753423042709 LBA88 Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Randomized open-label phase III LITESPARK-005 study. https://www.sciencedirect.com/science/article/pii/S0923753423042345 LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer. https://pubmed.ncbi.nlm.nih.gov/37119051/ 177Lu-Labeled Prostate-Specific Membrane Antigen Radioligand Therapy of Metastatic Castration-Resistant Prostate Cancer: Safety and Efficacy. https://pubmed.ncbi.nlm.nih.gov/26795286/

Spor af radioaktiv lutetium dukker op på et krematorie i USA. Tag med til en af livets endestationer og hør, hvad den sidste af lantaniderne laver der - og hvordan en sjælden jordartsfjer bliver til fem faretruende høns.Periodisk – en RAKKERPAK original produceret af Rakkerpak Productions.Historierne du hører bygger på journalistisk research og fakta. De kan indeholde fiktive elementer som for eksempel dialog.Hvis du kan lide min fortælling, så husk at gå ind og abonnér, give en anmeldelse og fortæl dine venner om Periodisk.Podcasten er blevet til med støtte fra Novo Nordisk Fonden. Hvis du vil vide mere kan du besøge vores website periodisk.dkAfsnittet er skrevet og tilrettelagt af Maya ZachariassenTor Arnbjørn og Dorte Palle er producereRene Slott står for lyddesign og mixSimon Bennebjerg er vært

Utvecklingen i forskningen kring metastaserad prostatacancer har skett explosionsartat. Så snabbt att överläkaren i onkologi Ingela Franck Lissbrant nu talar om ett paradigmskifte med en mängd nya bromsande behandlingar. Och kanske kan på sikt även mycket aggressiv prostatacancer bli kronisk och inte längre dödlig. I den här podden talar vi om allt det som kan ge mig och andra drabbade ett längre liv. Ingela Franck Lissbrant anses vara en av landets främsta experter på spridd prostatacancer. Hon är överläkare på onkologkliniken vid Hallands sjukhus och ordförande för Nationella prostatacancerregistret. I det här poddsamtalet tar vi bl a upp följande: - Vad är den medicinska nyttan med hormonläkemedel som Zytiga? - Kan man stråla bort metastaser? - Varför blir cancer resistent mot hormonbehandling? - Vilka olika former av cytostatika sätter läkarna in, och när, i behandlingen? - Vilka är biverkningarna av cytostatika idag? - Hur fungerar Radium 123 mot cancer? - Vad menar läkarna med begreppet överlevnadsvinst? - Vad är det speciella med den nya målsökande behandlingen Lutetium? - Varför har Lutetium använts vid det finska privatsjukhuset Docrates sedan 2017, men inte i Sverige? - När blir behandling med stamceller etablerat mot prostatacancer? - Hur kommer man med i olika forskningsstudier? - Kan patienter med en avancerad cancer kräva att få en egen personliga läkare (PAL)? - Kommer spridd prostatacancer kunna bli botbar? Och när? Lyssna på ett spännande samtal om paradigmskiftet inom behandlingar av agressiv prostatacancer.

Treatment of prostate cancer has changed dramatically over the years, with  multiple treatment options including chemotherapy, refined hormonal therapies, radiotherapies, surgery and others currently available, depending on the patient and their disease.Dr Sakir Mutevelic, Chief Medical Officer at Curium, has witnessed the tremendous progress in cancer treatment options and the increased survival rate that goes with them.  Today, we're talking with him about an investigational treatment for metastatic castration resistant prostate cancer in development at Curium, that could be a valuable new asset in disease management.Information for clinicians about the Eclipse trial is available here.For patients, a web portal with more information is available here.All trial data is available at:  https://clinicaltrials.gov/ct2/show/NCT05204927

Christopher Wee, MD, a medical oncologist from the Genitourinary Medical Oncology Program at Taussig Cancer Institute joins the Cancer Advances podcast to talk about therapies for metastatic prostate cancer. Listen as Dr. Wee discusses Lutetium-PSMA and the clinical trials that showed patients had better response rates and fewer toxicities when they got lutetium on top of their care.

An interview with Dr. Rohan Garje from Miami Cancer Institute in Miami, FL, lead author on "Systemic Therapy Update on 177Lutetium-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: ASCO Rapid Recommendation." Dr. Garje reviews the new evidence and the latest recommendation update for the use of 177Lu-PSMA-617, a radioligand therapy in patients with PSMA-positive mCRPC, along with it's implications for clinicians and patients. For more information, visit www.asco.org/genitourinary-cancer-guidelines.   TRANSCRIPT Brittany Harvey: Hello, and welcome to the ASCO Guidelines Podcast series, brought to you by the ASCO Podcast Network; a collection of nine programs, covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all the shows, including this one at: asco.org/podcast. My name is Brittany Harvey, and today I'm interviewing Dr. Rohan Garje from Miami Cancer Institute in Miami, Florida, lead author on, ‘Systemic Therapy Update on 177Lutetium-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: ASCO Rapid Recommendation'. Thank you for being here, Dr. Garje. Dr. Rohan Garje: Absolutely. Thank you so much for having me, Brittany. Brittany Harvey: Great. And first, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO Conflict of Interest policy is followed for each guideline. The full Conflict of Interest information for this guideline panel is available online with the publication of the guideline in the Journal of Clinical Oncology. Dr. Garje, do you have any relevant disclosures that are directly related to this guideline topic? Dr. Rohan Garje: Yes. I have received institutional research funding from Pfizer, Amgen, Endocyte, and AAA, who have drugs for the treatment of prostate cancer. Brittany Harvey: Excellent. Thank you for those disclosures. Then getting into the content of this guideline update, what prompted this rapid update to the ‘ASCO Guideline on Systemic Therapy in Men with Metastatic Castration-Resistant Prostate Cancer', which was previously published in 2014? Dr. Rohan Garje: Since 2014, there have been several new drugs that have been approved for prostate cancer management. And most recently in March 2022, FDA has approved 177Lutetium-PSMA-617 for patients with PSMA scan-positive metastatic castration-resistant prostate cancer. This led to the team from ASCO to develop this new rapid recommendation update. Now, this approval actually has been based on the efficacy data published in Vision clinical trials. To give you a little background about Lutetium, it is a novel β-energy-emitting radioligand therapy. In this particular study, this agent was combined with best standard of care, and compared to best standard care alone, in men with metastatic castration-resistant prostate cancer, who had a positive PSMA scan. Briefly, the study was both clinically and statistically positive, and has shown improvement in both overall survival and radiographic progression-free survival. The median overall survival was about 15.3 months with the combination therapy, compared to 11.3 months with the standard care arm. Brittany Harvey: Great. And then based off this new evidence and the new approval from the FDA for 177 Lutetium-PSMA-617, what are the updated recommendations from the guideline panel? Dr. Rohan Garje: The panel recommends the use of 177 Lutetium-PSMA-617 as a treatment option in patients with PSMA PET/CT positive metastatic castration-resistant prostate cancer, who have been previously treated with at least one line of androgen receptor pathway inhibitor, and at least one line of prior axon-based chemotherapy. Brittany Harvey: Great. And then, what should clinicians know as they implement the use of this drug and this new recommendation by the guideline panel? Dr. Rohan Garje: A very good question. It is important to select patients based on a positive PSMA scan. That is, all the metastatic lesions should be positive on the PSMA scan, and there should not be any large lymph nodes or visceral organ metastatic disease that are PSMA negative. Additionally, physicians can use Gallium 68 PSMA-11, or F-18 Piflufolastat as radio tracers for PSMA scan to determine eligibility. Additionally, there are several other factors that need to be considered, such as: the patient should have baseline good blood counts, as well as renal function to be eligible for this therapy, as this treatment has a potential to cause mild suppression and impairment of renal function. The most common side effects associated with this drug are fatigue, dry mouth, dry eyes, and nausea. The treatment in general is for four to six cycles. Each cycle is for every six weeks. The fifth and sixth cycles should be considered only if patients are responding well to the therapy and have no significant toxicities. It is also important for the physicians to note that there are several additional treatment options for patients with metastatic castration-resistant prostate cancer, who had prior anti-androgen docetaxel therapy. They include; Cabazitaxel, PARP inhibitors for patients who have mutations in DNA repair, gene mutations such as BRCA1 and BRCA2, and immunotherapy with Pembrolizumab for patients with MSI-high status, or tumor mutation burden greater than 10. Brittany Harvey: Thank you for describing that nuance behind the recommendations. So then, in addition, how does this update impact patients with metastatic castration-resistant prostate cancer? Dr. Rohan Garje: 177 Lutetium-PSMA-617 is the first radioligand therapy approved for the treatment of prostate cancer. Previously, we had Radium-223 as a radiopharmaceutical, but this particular agent is unique in the sense, it is a radioligand therapy where it is chelated to PSMA. So, it is very targeted therapy which works for both bone and visceral organ metastasis. So, this is an exciting treatment option for patients, as it has been shown to have improvement in overall survival. This adds to the current treatment choices of anti-androgens, chemotherapy, as well as targeted therapies for prostate cancer patients. Brittany Harvey: Great. It's exciting to have a new treatment option for patients. So then finally, what are the outstanding questions regarding systemic therapy for metastatic castration-resistant prostate cancer? Dr. Rohan Garje: We are at an exciting stage in the management of prostate cancer. In the last decade, we have seen several new drugs; some are specific targeted agents, some are specific immunotherapy agents. Now, we are entering into this realm of radioligand therapy, which is very exciting. There are several other novel radioligand therapies such as; Actinium, Thorium, Lead, which are being evaluated in the treatment of prostate cancer. So, in the next several years, we will see several new drugs that have been developed. In addition, there are other agents called T-cell-engaging therapies, which are being evaluated to improve the outcomes. So, the last decade definitely has seen a lot of new improvements, but we are so excited that several new treatment choices are now available for patients, and several are in clinical evaluation. So, the future is bright for the patients with prostate cancer, where we have several new treatment choices to improve their outcomes. Brittany Harvey: It sounds like an exciting time for developments in prostate cancer. So, I want to thank you so much for your time today, Dr. Garje, and thank you for all of the work you did to update this guideline. Dr. Rohan Garje: Thank you so much. I really thank ASCO leadership and the team for giving me this opportunity, and thank you, Brittany, for hosting me on this podcast. Brittany Harvey: And thank you to all of our listeners for tuning into ASCO Guidelines Podcast series. To read the full guideline, go to: www.asco.org/genitourinary-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO guidelines app, available in iTunes or the Google Play store. If you have enjoyed what you've heard today, please rate and review the podcast, and be sure to subscribe, so you never miss an episode.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement.    

Experts: Ursula Vogl, Cantonal Hospital of Southern Switzerland, Bellinzona, Switzerland Niklaus Schaefer, University Hospital of Canton Vaud, Lausanne, Switzerland

Editor-in-Chief, Robert Amdur, MD, explains the group of six papers on radiopharmaceutical therapy published in the July/August issue of Practical Radiation Oncology. These papers summarize the information clinicians need to know to direct radiopharmaceutical therapy in their clinic. Two papers explain background information and four focus on patient selection and the details of administration when using Lutetium-177 DOTATATE for neuroendocrine cancer, and Lutetium-177 PSMA or Radium- 223 for prostate cancer.

Editor-in-Chief, Robert Amdur, MD, explains the group of six papers on radiopharmaceutical therapy published in the July/August issue of Practical Radiation Oncology. These papers summarize the information clinicians need to know to direct radiopharmaceutical therapy in their clinic. Two papers explain background information and four focus on patient selection and the details of administration when using Lutetium-177 DOTATATE for neuroendocrine cancer, and Lutetium-177 PSMA or Radium- 223 for prostate cancer.

Phillip Kuo discusses the biomarker to select patients for therapy.

Listen to a soundcast of the March 23, 2022 FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for metastatic castration-resistant prostate cancer

In this podcast, Dr. Alicia Morgans discusses recent data presented at the 2022 ASCO GU Cancers Symposium, including trials evaluating the use of first-line PARP inhibitors in combination with abiraterone for mCRPC, continuation of enzalutamide after progression, and imaging modalities as predictive and prognostic biomarkers. This activity is available for CE/CME credit. Claim your credit at pce.is/ascogu.Contributors: Dr Morgans has disclosed that she has received funds for research support from Atellas, AstraZeneca, Bayer, Myovant, and Pfizer, and consulting fees from AAA, Astellas, AstraZeneca, Bayer, Blue Earth, Clovis, Dendreon, Janssen, Lantheus, Merck, Myovant, Novartis, Pfizer, Sanofi, and Telix.Ms Martone has no relevant conflicts of interest to report. 

Nucleair geneeskundige prof. dr. Lioe-Fee de Geus-Oei uit het Leids Universitair Medisch Centrum bespreekt met nucleair geneeskundigen dr. Larissa van Golen uit het Antoni van Leeuwenhoek te Amsterdam en prof. dr. Marnix Lam uit het UMC Utrecht de nieuwe mogelijkheden voor radionuclide therapieën. Tijdens dit gesprek bespreken zij wat theranostics inhoudt, bespreken zij de VISION-trial en zoomen zij in op de klinische implicaties van Lutetium-177-PSMA therapie.

Австралійські лікарі заявили про позитивні результати після випробувань нового класу препаратів у лікуванні на пізній стадії раку простати.  Ця хвороба, як кажуть науковці й лікарі, важко піддається лікуванню і 3200 австралійських чоловіків все ще помирають від раку простати щороку. І ось нове повідомлення про перше в світі комбіноване випробування препаратів (Lutetium i Veyonda) дає нову надію пацієнтам...

Featuring perspectives from Prof Simon Chowdhury, including the following topics: Introduction (0:00) Prostate Cancer Genomic Landscape (1:11) Lutetium-177-PSMA-617 (8:45) Case: A man in his late 60s with metastatic castration-resistant prostate cancer (mCRPC) and a germline BRCA2 mutation — Zanetta S Lamar, MD (14:33) Case: A man in his early 80s with mCRPC and a somatic BRCA2 mutation — Kelly Yap, MD (29:30) Case: A man in his late 60s with BRCA1/2 wild-type mCRPC — Jason Hafron, MD (31:37) Case: A man in his late 60s with metastatic hormone-sensitive prostate cancer and an ARID1A mutation — Syed F Zafar, MD (35:52) Case: A man in his mid-80s with M0 CRPC — Shachar Peles, MD (42:16) Case: A man in his early 60s with BRCA1/2 wild-type mCRPC — Sunil Gandhi, MD (51:12) Protocol and off-protocol treatment approaches for oligometastatic prostate cancer — David S Morris, MD (54:12) CME information and select publications

Dacian Domide's Lutetium 177 podcast

Guest host Dr. Neeraj Agarwal, editor-in-chief of ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah Huntsman Cancer Institute, interviews Dr. Oliver Sartor, medical director of the Tulane Cancer Center in New Orleans, on the practice-changing VISION trial and its impact on the current treatment paradigm for mCRPC. Transcript ASCO Daily News: Welcome to the ASCO Daily News Podcast. Our topic today is the practice-changing VISION trial, a phase III trial of radioligand therapy in patients with metastatic castration-resistant prostate cancer. Our guest host, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, will speak with one of the trial's investigators, Dr. Oliver Sartor, the medical director of the Tulane Cancer Center and Laborde Professor for Cancer Research. Their full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the Daily News Podcast are available on our transcripts at asco.org/podcasts.   Dr. Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I am with Dr. Oliver Sartor. Today, we are going to discuss one of the practice-changing trials in the context of metastatic castration-resistant prostate cancer. Welcome to the ASCO Daily News Podcast, Dr. Sartor. Thanks for taking the time to be with us today.   Dr. Oliver Sartor: Thank you, Neeraj. A pleasure to be here.   Dr. Neeraj Agarwal: You recently published the primary results of the phase III VISION trial, which tested the efficacy of a novel radioligand therapy, Lutetium-177-PSMA-617, in men with metastatic castrate-resistant prostate cancer. Could you please tell us more about this compound and why you did this study?   Dr. Oliver Sartor:  So I'll start off with the compound itself. Radioligand therapy is a therapy that has a little warhead, and that warhead in this case is Lutetium-177. But it's guided by binding to PSMA. Now, PSMA is prostate-specific membrane antigen, and many of us are familiar with it, but some may not be. So PSMA is a protein expressed on the surface of most prostate cancer cells. Not all patients have it, but most do. And the ability of the PSMA Lutetium-177 to target the cancer was indicated in some preliminary studies, but they have not been to phase III. So the purpose of the phase III VISION trial was really to design a definitive study to look at overall survival, in particular, to determine whether or not this agent was truly active. And the good news is, it is truly active. And in the VISION trial, we were able to not only extend life with an overall survival benefit, haz ratio 0.62, but there was also a time-to-progression image-based radiographic progression-free survival. It was also much in favor of the PSMA Lutetium with a haz ratio of 0.4. So whether or not you look at time to cancer progression or whether or not you look at overall survival, this is an effective therapy. It, of course, does have some adverse side effects. We can talk more about that, but it's reasonably well tolerated. And I do anticipate that there'll be an FDA approval as a consequence of these pivotal findings.   Dr. Neeraj Agarwal: These are wonderful results and news for our patients. Please tell me how it will affect the current treatment paradigm of our patients with mCRPC. As we know, you selected patients who had disease progression on chemotherapy with taxanes and novel hormonal therapy. But real-world studies, many of which were published by you, have shown that docetaxel is received by a minority of patients with metastatic prostate cancer. So how do you envision treating your patients who do not want to be treated with chemotherapy as many of my patients do? How will you apply Lutetium-177 in their treatment?   Dr. Oliver Sartor:  Well, Neeraj, I think that we're going to be restricted in accordance with the label that the FDA provides. And I fully expect that the label will include a progression after treatment with docetaxel or at least one taxane-based therapy because that's the way the VISION trial was constructed. Now, you're raising a very critical point, and that is, what about the individuals that do not want to receive or are ineligible to receive a chemotherapy such as docetaxel? And for those individuals, we now have a new trial called PSMA4, and that trial is going to be testing the Lutetium-177-PSMA-617 in the context of chemotherapy-naive patients. So I think we're going to have to wait until we have more results, more clinical trials completed, prior to the application of PSMA-617 into the more general population of chemotherapy-naive patients. But those clinical trials are now underway.   Dr. Neeraj Agarwal: That's great. So, Oliver, in the VISION trial, you did mandate a diagnostic PSMA PET scan, and patients who were positive on the diagnostic PSMA PET scan were deemed to be eligible for enrollment on the VISION trial. Do you expect FDA to include diagnostic PSMA scan for eligibility for treatment with the Lutetium-177 in the real-world setting? If it doesn't or if it does, how it is going to affect the treatment of our patients, that availability of treatment for our patients?   Dr. Oliver Sartor:  That's really a great question. And I do expect that PSMA PET imaging will be a criteria given that it was used for patient selection. Now, as it turned out, about 87% of the patients actually did qualify after getting a PSMA PET scan. And given that that was part of the inclusion criteria, I anticipate that the FDA will also incorporate such imaging. Now, it does get to be a bit of an issue because it turns out that PSMA PET is just now coming into more widespread use. We did have, in May of this year, the approval by the FDA for the PSMA PET imaging agent and-- I shouldn't say "the"-- a PSMA PET imaging agent. Prior to that, in December of last year, there was both UCLA and UCSF approval by the FDA for yet another PSMA PET imaging agent. As we move forward, I anticipate that PET imaging is going to be more widely available. And of course, we don't have the approval as of yet today for the PSMA-617-Lutetium-177. And when we do get the anticipated approval, which likely will be in 2022, then I also anticipate that PSMA PET will be more widely available. Now, there are still issues with reimbursement for PSMA PET, and we've encountered those in our own practice. But that's a rapidly changing area, and we're working with the insurance companies in an effort to ensure that patients will get the imaging that they need.   Dr. Neeraj Agarwal:  Got it. And obviously, I asked this question because many of my community friends and colleagues have asked me this question.  Before we talk about the side effects of Lutetium-177, would you have any message for our friends and colleagues in the community who are bracing themselves for treating their patients with the Lutetium-177, whether they should be proactive in establishing contacts and relationships with the nuclear medicine facilities and so on?   Dr. Oliver Sartor:  That's a great question, Neeraj, because I think you're raising a very important point. This is going to be the type of therapy that involves multidisciplinary care. We can see that there'll be diagnostic PET imaging as being a component of the study. There'll be the necessity of licensed physicians, typically either nuclear medicine or radiation oncology, to actually administer the drug. And then, quite frankly, the medical oncologists or those urologists who are trained in advanced prostate cancer are going to need to manage the patient. This is a lot more than just getting an injection. Many of these patients are ill. They need to have symptom management. They need to manage their bone health. They need to manage their hormonal manipulations. They need management with regard to pain. So this is not just about giving an injection. And I encourage those people who are interested to involve multidisciplinary teams starting now. And I realize that the therapy is not available now, but you have to anticipate that it will be. And I think it will be a game changer of a therapy, and many patients are going to want it. So that means it's incumbent upon the physicians to be prepared, and that means multidisciplinary care.   Dr. Neearj Agarwal:  Excellent point. So basically, we should be ready. We should start establishing relationships with nuclear medicine facilities or radiation oncologists who are going to deliver Lutetium-177. Overall, when I was reading the New England Journal paper, the side effect profile seemed very reasonable. I did not see any red flags. To me, it sounded like a pretty well-tolerated drug. So what is your take on the side effects of Lutetium-177?   Dr. Oliver Sartor: I think the side effects are quite manageable. One of the unique side effects is that of dry mouth and that's because the PSMA can actually be expressed in the salivary glands and that there is some potential for salivary gland binding in the PSMA-617-Lutetium. And that means that you can have damage to the salivary glands, and that means dry mouth. It turns out that a little over 40% of the patients actually did complain of a dry mouth, and that needs to be managed typically with fluid intake or various ways of mouth moisturizers. Fatigue is a potential issue. It was raised, as well as some bone marrow suppression. And if you look at the grade 3/4 toxicities, anemia was present a little more than 10% of the time. And that, of course, needs to be monitored. There is some potential collateral damage to the bone marrow. So these patients need to have their counts monitored. They need to have their symptoms assessed. And they need to be managed as they go through the process. It's not just about giving an injection, but clearly, the licensed individuals, including nuclear medicine and radiation oncology, need to be engaged, because without them, there is no injection. So this is a complex multidisciplinary care paradigm. And emphasizing the point, symptom management, yes; adverse event management, yes. But you have to deliver the drug, and that means multidisciplinary care.   Dr. Neeraj Agarwal:  Those are fantastic points. Thank you very much, Dr. Sartor, for taking time to be with us. And I'm really hoping that this podcast will be very enriching to our listeners. Thank you very much.   Dr. Oliver Sartor: Thank you, Neeraj. Glad to be here.   ASCO Daily News:  You've been listening to Dr. Neeraj Agarwal of the Huntsman Cancer Institute and Dr. Oliver Sartor of the Tulane Cancer Center. Our listeners will find a link to the VISION study in the transcript of this episode. Thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclosures: Dr. Neeraj Agarwal Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai,    Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences   Research Funding (Inst.): Bayer Your Institution, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen,    AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas     Disclosures: Dr. Oliver Sartor Stocks & Other Ownership Interests: Lilly, GlaxoSmithKline, Abbvie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Inc., Clovis Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Constellation Pharmaceuticals, Advanced Accelerator Applications, Pfizer, Bristol-Myers Squibb, Bavarian Nordic, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant, Myriad Genetics, Novartis, Clarify Pharmaceuticals, Fusion, Istopen Technologien Meunchen, Janssen, Noxopharm, Clovis, Noria Therapeutics, Point Biopharma, TeneoBio, Telix, Theragnostics Research Funding (Inst): Sotio, Janssen, Progenics, Bayer, Sanofi, Endocyte, Merck, Invitae, Constellation Pharmaceuticals, Advanced Accelerator Applications, Dendreon, AstraZeneca Expert Testimony: Sanofi Travel, Accommodations, Expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Dr. Oliver Sartor on the VISION Trial and Improving Care for Patients With mCRPC       ASCO Daily News: Welcome to the ASCO Daily News Podcast. Our topic today is the practice-changing VISION trial, a phase III trial of radioligand therapy in patients with metastatic castration-resistant prostate cancer. Our guest host, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, will speak with one of the trial's investigators, Dr. Oliver Sartor, the medical director of the Tulane Cancer Center and Laborde Professor for Cancer Research. Their full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the Daily News Podcast are available on our transcripts at asco.org/podcasts.   Dr. Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I am with Dr. Oliver Sartor. Today, we are going to discuss one of the practice-changing trials in the context of metastatic castration-resistant prostate cancer. Welcome to the ASCO Daily News Podcast, Dr. Sartor. Thanks for taking the time to be with us today.   Dr. Oliver Sartor: Thank you, Neeraj. A pleasure to be here.   Dr. Neeraj Agarwal: You recently published the primary results of the phase III VISION trial, which tested the efficacy of a novel radioligand therapy, Lutetium-177-PSMA-617, in men with metastatic castrate-resistant prostate cancer. Could you please tell us more about this compound and why you did this study?   Dr. Oliver Sartor:  So I'll start off with the compound itself. Radioligand therapy is a therapy that has a little warhead, and that warhead in this case is Lutetium-177. But it's guided by binding to PSMA. Now, PSMA is prostate-specific membrane antigen, and many of us are familiar with it, but some may not be. So PSMA is a protein expressed on the surface of most prostate cancer cells. Not all patients have it, but most do. And the ability of the PSMA Lutetium-177 to target the cancer was indicated in some preliminary studies, but they have not been to phase III. So the purpose of the phase III VISION trial was really to design a definitive study to look at overall survival, in particular, to determine whether or not this agent was truly active. And the good news is, it is truly active. And in the VISION trial, we were able to not only extend life with an overall survival benefit, haz ratio 0.62, but there was also a time-to-progression image-based radiographic progression-free survival. It was also much in favor of the PSMA Lutetium with a haz ratio of 0.4. So whether or not you look at time to cancer progression or whether or not you look at overall survival, this is an effective therapy. It, of course, does have some adverse side effects. We can talk more about that, but it's reasonably well tolerated. And I do anticipate that there'll be an FDA approval as a consequence of these pivotal findings.   Dr. Neeraj Agarwal: These are wonderful results and news for our patients. Please tell me how it will affect the current treatment paradigm of our patients with mCRPC. As we know, you selected patients who had disease progression on chemotherapy with taxanes and novel hormonal therapy. But real-world studies, many of which were published by you, have shown that docetaxel is received by a minority of patients with metastatic prostate cancer. So how do you envision treating your patients who do not want to be treated with chemotherapy as many of my patients do? How will you apply Lutetium-177 in their treatment?   Dr. Oliver Sartor:  Well, Neeraj, I think that we're going to be restricted in accordance with the label that the FDA provides. And I fully expect that the label will include a progression after treatment with docetaxel or at least one taxane-based therapy because that's the way the VISION trial was constructed. Now, you're raising a very critical point, and that is, what about the individuals that do not want to receive or are ineligible to receive a chemotherapy such as docetaxel? And for those individuals, we now have a new trial called PSMA4, and that trial is going to be testing the Lutetium-177-PSMA-617 in the context of chemotherapy-naive patients. So I think we're going to have to wait until we have more results, more clinical trials completed, prior to the application of PSMA-617 into the more general population of chemotherapy-naive patients. But those clinical trials are now underway.   Dr. Neeraj Agarwal: That's great. So, Oliver, in the VISION trial, you did mandate a diagnostic PSMA PET scan, and patients who were positive on the diagnostic PSMA PET scan were deemed to be eligible for enrollment on the VISION trial. Do you expect FDA to include diagnostic PSMA scan for eligibility for treatment with the Lutetium-177 in the real-world setting? If it doesn't or if it does, how it is going to affect the treatment of our patients, that availability of treatment for our patients?   Dr. Oliver Sartor:  That's really a great question. And I do expect that PSMA PET imaging will be a criteria given that it was used for patient selection. Now, as it turned out, about 87% of the patients actually did qualify after getting a PSMA PET scan. And given that that was part of the inclusion criteria, I anticipate that the FDA will also incorporate such imaging. Now, it does get to be a bit of an issue because it turns out that PSMA PET is just now coming into more widespread use. We did have, in May of this year, the approval by the FDA for the PSMA PET imaging agent and-- I shouldn't say "the"-- a PSMA PET imaging agent. Prior to that, in December of last year, there was both UCLA and UCSF approval by the FDA for yet another PSMA PET imaging agent. As we move forward, I anticipate that PET imaging is going to be more widely available. And of course, we don't have the approval as of yet today for the PSMA-617-Lutetium-177. And when we do get the anticipated approval, which likely will be in 2022, then I also anticipate that PSMA PET will be more widely available. Now, there are still issues with reimbursement for PSMA PET, and we've encountered those in our own practice. But that's a rapidly changing area, and we're working with the insurance companies in an effort to ensure that patients will get the imaging that they need.   Dr. Neeraj Agarwal:  Got it. And obviously, I asked this question because many of my community friends and colleagues have asked me this question.  Before we talk about the side effects of Lutetium-177, would you have any message for our friends and colleagues in the community who are bracing themselves for treating their patients with the Lutetium-177, whether they should be proactive in establishing contacts and relationships with the nuclear medicine facilities and so on?   Dr. Oliver Sartor:  That's a great question, Neeraj, because I think you're raising a very important point. This is going to be the type of therapy that involves multidisciplinary care. We can see that there'll be diagnostic PET imaging as being a component of the study. There'll be the necessity of licensed physicians, typically either nuclear medicine or radiation oncology, to actually administer the drug. And then, quite frankly, the medical oncologists or those urologists who are trained in advanced prostate cancer are going to need to manage the patient. This is a lot more than just getting an injection. Many of these patients are ill. They need to have symptom management. They need to manage their bone health. They need to manage their hormonal manipulations. They need management with regard to pain. So this is not just about giving an injection. And I encourage those people who are interested to involve multidisciplinary teams starting now. And I realize that the therapy is not available now, but you have to anticipate that it will be. And I think it will be a game changer of a therapy, and many patients are going to want it. So that means it's incumbent upon the physicians to be prepared, and that means multidisciplinary care.   Dr. Neearj Agarwal:  Excellent point. So basically, we should be ready. We should start establishing relationships with nuclear medicine facilities or radiation oncologists who are going to deliver Lutetium-177. Overall, when I was reading the New England Journal paper, the side effect profile seemed very reasonable. I did not see any red flags. To me, it sounded like a pretty well-tolerated drug. So what is your take on the side effects of Lutetium-177?   Dr. Oliver Sartor: I think the side effects are quite manageable. One of the unique side effects is that of dry mouth and that's because the PSMA can actually be expressed in the salivary glands and that there is some potential for salivary gland binding in the PSMA-617-Lutetium. And that means that you can have damage to the salivary glands, and that means dry mouth. It turns out that a little over 40% of the patients actually did complain of a dry mouth, and that needs to be managed typically with fluid intake or various ways of mouth moisturizers. Fatigue is a potential issue. It was raised, as well as some bone marrow suppression. And if you look at the grade 3/4 toxicities, anemia was present a little more than 10% of the time. And that, of course, needs to be monitored. There is some potential collateral damage to the bone marrow. So these patients need to have their counts monitored. They need to have their symptoms assessed. And they need to be managed as they go through the process. It's not just about giving an injection, but clearly, the licensed individuals, including nuclear medicine and radiation oncology, need to be engaged, because without them, there is no injection. So this is a complex multidisciplinary care paradigm. And emphasizing the point, symptom management, yes; adverse event management, yes. But you have to deliver the drug, and that means multidisciplinary care.   Dr. Neeraj Agarwal:  Those are fantastic points. Thank you very much, Dr. Sartor, for taking time to be with us. And I'm really hoping that this podcast will be very enriching to our listeners. Thank you very much.   Dr. Oliver Sartor: Thank you, Neeraj. Glad to be here.   ASCO Daily News:  You've been listening to Dr. Neeraj Agarwal of the Huntsman Cancer Institute and Dr. Oliver Sartor of the Tulane Cancer Center. Our listeners will find a link to the VISION study in the transcript of this episode. Thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclosures: Dr. Neeraj Agarwal Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai,    Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences   Research Funding (Inst.): Bayer Your Institution, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen,    AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas     Disclosures: Dr. Oliver Sartor Stocks & Other Ownership Interests: Lilly, GlaxoSmithKline, Abbvie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Inc., Clovis Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Constellation Pharmaceuticals, Advanced Accelerator Applications, Pfizer, Bristol-Myers Squibb, Bavarian Nordic, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant, Myriad Genetics, Novartis, Clarify Pharmaceuticals, Fusion, Istopen Technologien Meunchen, Janssen, Noxopharm, Clovis, Noria Therapeutics, Point Biopharma, TeneoBio, Telix, Theragnostics Research Funding (Inst): Sotio, Janssen, Progenics, Bayer, Sanofi, Endocyte, Merck, Invitae, Constellation Pharmaceuticals, Advanced Accelerator Applications, Dendreon, AstraZeneca Expert Testimony: Sanofi Travel, Accommodations, Expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Dr. Oliver Sartor on the VISION Trial and Improving Care for Patients With mCRPC       ASCO Daily News: Welcome to the ASCO Daily News Podcast. Our topic today is the practice-changing VISION trial, a phase III trial of radioligand therapy in patients with metastatic castration-resistant prostate cancer. Our guest host, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, will speak with one of the trial's investigators, Dr. Oliver Sartor, the medical director of the Tulane Cancer Center and Laborde Professor for Cancer Research. Their full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the Daily News Podcast are available on our transcripts at asco.org/podcasts.   Dr. Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I am with Dr. Oliver Sartor. Today, we are going to discuss one of the practice-changing trials in the context of metastatic castration-resistant prostate cancer. Welcome to the ASCO Daily News Podcast, Dr. Sartor. Thanks for taking the time to be with us today.   Dr. Oliver Sartor: Thank you, Neeraj. A pleasure to be here.   Dr. Neeraj Agarwal: You recently published the primary results of the phase III VISION trial, which tested the efficacy of a novel radioligand therapy, Lutetium-177-PSMA-617, in men with metastatic castrate-resistant prostate cancer. Could you please tell us more about this compound and why you did this study?   Dr. Oliver Sartor:  So I'll start off with the compound itself. Radioligand therapy is a therapy that has a little warhead, and that warhead in this case is Lutetium-177. But it's guided by binding to PSMA. Now, PSMA is prostate-specific membrane antigen, and many of us are familiar with it, but some may not be. So PSMA is a protein expressed on the surface of most prostate cancer cells. Not all patients have it, but most do. And the ability of the PSMA Lutetium-177 to target the cancer was indicated in some preliminary studies, but they have not been to phase III. So the purpose of the phase III VISION trial was really to design a definitive study to look at overall survival, in particular, to determine whether or not this agent was truly active. And the good news is, it is truly active. And in the VISION trial, we were able to not only extend life with an overall survival benefit, haz ratio 0.62, but there was also a time-to-progression image-based radiographic progression-free survival. It was also much in favor of the PSMA Lutetium with a haz ratio of 0.4. So whether or not you look at time to cancer progression or whether or not you look at overall survival, this is an effective therapy. It, of course, does have some adverse side effects. We can talk more about that, but it's reasonably well tolerated. And I do anticipate that there'll be an FDA approval as a consequence of these pivotal findings.   Dr. Neeraj Agarwal: These are wonderful results and news for our patients. Please tell me how it will affect the current treatment paradigm of our patients with mCRPC. As we know, you selected patients who had disease progression on chemotherapy with taxanes and novel hormonal therapy. But real-world studies, many of which were published by you, have shown that docetaxel is received by a minority of patients with metastatic prostate cancer. So how do you envision treating your patients who do not want to be treated with chemotherapy as many of my patients do? How will you apply Lutetium-177 in their treatment?   Dr. Oliver Sartor:  Well, Neeraj, I think that we're going to be restricted in accordance with the label that the FDA provides. And I fully expect that the label will include a progression after treatment with docetaxel or at least one taxane-based therapy because that's the way the VISION trial was constructed. Now, you're raising a very critical point, and that is, what about the individuals that do not want to receive or are ineligible to receive a chemotherapy such as docetaxel? And for those individuals, we now have a new trial called PSMA4, and that trial is going to be testing the Lutetium-177-PSMA-617 in the context of chemotherapy-naive patients. So I think we're going to have to wait until we have more results, more clinical trials completed, prior to the application of PSMA-617 into the more general population of chemotherapy-naive patients. But those clinical trials are now underway.   Dr. Neeraj Agarwal: That's great. So, Oliver, in the VISION trial, you did mandate a diagnostic PSMA PET scan, and patients who were positive on the diagnostic PSMA PET scan were deemed to be eligible for enrollment on the VISION trial. Do you expect FDA to include diagnostic PSMA scan for eligibility for treatment with the Lutetium-177 in the real-world setting? If it doesn't or if it does, how it is going to affect the treatment of our patients, that availability of treatment for our patients?   Dr. Oliver Sartor:  That's really a great question. And I do expect that PSMA PET imaging will be a criteria given that it was used for patient selection. Now, as it turned out, about 87% of the patients actually did qualify after getting a PSMA PET scan. And given that that was part of the inclusion criteria, I anticipate that the FDA will also incorporate such imaging. Now, it does get to be a bit of an issue because it turns out that PSMA PET is just now coming into more widespread use. We did have, in May of this year, the approval by the FDA for the PSMA PET imaging agent and-- I shouldn't say "the"-- a PSMA PET imaging agent. Prior to that, in December of last year, there was both UCLA and UCSF approval by the FDA for yet another PSMA PET imaging agent. As we move forward, I anticipate that PET imaging is going to be more widely available. And of course, we don't have the approval as of yet today for the PSMA-617-Lutetium-177. And when we do get the anticipated approval, which likely will be in 2022, then I also anticipate that PSMA PET will be more widely available. Now, there are still issues with reimbursement for PSMA PET, and we've encountered those in our own practice. But that's a rapidly changing area, and we're working with the insurance companies in an effort to ensure that patients will get the imaging that they need.   Dr. Neeraj Agarwal:  Got it. And obviously, I asked this question because many of my community friends and colleagues have asked me this question.  Before we talk about the side effects of Lutetium-177, would you have any message for our friends and colleagues in the community who are bracing themselves for treating their patients with the Lutetium-177, whether they should be proactive in establishing contacts and relationships with the nuclear medicine facilities and so on?   Dr. Oliver Sartor:  That's a great question, Neeraj, because I think you're raising a very important point. This is going to be the type of therapy that involves multidisciplinary care. We can see that there'll be diagnostic PET imaging as being a component of the study. There'll be the necessity of licensed physicians, typically either nuclear medicine or radiation oncology, to actually administer the drug. And then, quite frankly, the medical oncologists or those urologists who are trained in advanced prostate cancer are going to need to manage the patient. This is a lot more than just getting an injection. Many of these patients are ill. They need to have symptom management. They need to manage their bone health. They need to manage their hormonal manipulations. They need management with regard to pain. So this is not just about giving an injection. And I encourage those people who are interested to involve multidisciplinary teams starting now. And I realize that the therapy is not available now, but you have to anticipate that it will be. And I think it will be a game changer of a therapy, and many patients are going to want it. So that means it's incumbent upon the physicians to be prepared, and that means multidisciplinary care.   Dr. Neearj Agarwal:  Excellent point. So basically, we should be ready. We should start establishing relationships with nuclear medicine facilities or radiation oncologists who are going to deliver Lutetium-177. Overall, when I was reading the New England Journal paper, the side effect profile seemed very reasonable. I did not see any red flags. To me, it sounded like a pretty well-tolerated drug. So what is your take on the side effects of Lutetium-177?   Dr. Oliver Sartor: I think the side effects are quite manageable. One of the unique side effects is that of dry mouth and that's because the PSMA can actually be expressed in the salivary glands and that there is some potential for salivary gland binding in the PSMA-617-Lutetium. And that means that you can have damage to the salivary glands, and that means dry mouth. It turns out that a little over 40% of the patients actually did complain of a dry mouth, and that needs to be managed typically with fluid intake or various ways of mouth moisturizers. Fatigue is a potential issue. It was raised, as well as some bone marrow suppression. And if you look at the grade 3/4 toxicities, anemia was present a little more than 10% of the time. And that, of course, needs to be monitored. There is some potential collateral damage to the bone marrow. So these patients need to have their counts monitored. They need to have their symptoms assessed. And they need to be managed as they go through the process. It's not just about giving an injection, but clearly, the licensed individuals, including nuclear medicine and radiation oncology, need to be engaged, because without them, there is no injection. So this is a complex multidisciplinary care paradigm. And emphasizing the point, symptom management, yes; adverse event management, yes. But you have to deliver the drug, and that means multidisciplinary care.   Dr. Neeraj Agarwal:  Those are fantastic points. Thank you very much, Dr. Sartor, for taking time to be with us. And I'm really hoping that this podcast will be very enriching to our listeners. Thank you very much.   Dr. Oliver Sartor: Thank you, Neeraj. Glad to be here.   ASCO Daily News:  You've been listening to Dr. Neeraj Agarwal of the Huntsman Cancer Institute and Dr. Oliver Sartor of the Tulane Cancer Center. Our listeners will find a link to the VISION study in the transcript of this episode. Thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclosures: Dr. Neeraj Agarwal Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai,    Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences   Research Funding (Inst.): Bayer Your Institution, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen,    AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas     Disclosures: Dr. Oliver Sartor Stocks & Other Ownership Interests: Lilly, GlaxoSmithKline, Abbvie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Inc., Clovis Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Constellation Pharmaceuticals, Advanced Accelerator Applications, Pfizer, Bristol-Myers Squibb, Bavarian Nordic, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant, Myriad Genetics, Novartis, Clarify Pharmaceuticals, Fusion, Istopen Technologien Meunchen, Janssen, Noxopharm, Clovis, Noria Therapeutics, Point Biopharma, TeneoBio, Telix, Theragnostics Research Funding (Inst): Sotio, Janssen, Progenics, Bayer, Sanofi, Endocyte, Merck, Invitae, Constellation Pharmaceuticals, Advanced Accelerator Applications, Dendreon, AstraZeneca Expert Testimony: Sanofi Travel, Accommodations, Expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    

In this episode, Chris Parker, MD, and Bertrand Tombal, MD, PhD, discuss the clinical implications of the latest data on radiopharmaceuticals in the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Topics include:Data from the PEACE-3 trial on the effect of bone-protective agents on fracture risk with enzalutamide plus radium-223Efficacy and toxicity of PSMA lutetium plus standard of care in the VISION trialOngoing trials evaluating radionuclides in combination with other agents in metastatic CRPCPresenters:Chris Parker, MDProfessor of Prostate OncologyInstitute of Cancer ResearchClinical OncologistDepartment of Uro-oncologyRoyal Marsden HospitalSutton, Surrey, United KingdomBertrand Tombal, MD, PhDProfessor of UrologyInstitut de Recherche Clinique (IRC)Cliniques universitaires Saint-LucChairmanDepartment of SurgeryCliniques universitaires Saint-LucBrussels, BelgiumLink to full program, including downloadable slides: https://bit.ly/36IEnNE

Featuring an interview with Dr Arjun Balar, including the following topics: Phase III VISION study: Lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (PC) (0:00) Updated safety outcomes from the EORTC 1333/PEACE III trial: Effect of adding bone-protecting agents (3:44) First results from the Phase III PEACE 1 study evaluating abiraterone acetate with prednisone and/or local radiation therapy for de novo metastatic castration-sensitive PC (5:09) Update on darolutamide tolerability: Outcomes with aggressive hormonal therapy for high-risk localized PC  (7:35) Bladder-sparing therapy with pembrolizumab, gemcitabine and concurrent hypofractionated radiation therapy for muscle-invasive bladder cancer (MIBC) (9:17) Results from the Phase II HCRN GU16-257 trial: Gemcitabine/cisplatin with nivolumab and selective bladder sparing for patients with MIBC (12:00) Long-term outcomes from the KEYNOTE-052 trial assessing first-line pembrolizumab for cisplatin-ineligible patients with advanced urothelial cancer (15:02) First-line maintenance therapy with avelumab for advanced urothelial cancer: Subgroup analysis of the JAVELIN Bladder 100 trial (17:19) Phase III CheckMate 9ER trial: Outcomes by baseline disease characteristics with nivolumab and cabozantinib for advanced renal cell carcinoma (RCC)  (18:29) Results from the Phase III KEYNOTE-564 study assessing pembrolizumab as postnephrectomy adjuvant therapy for patients with RCC  (20:16) Pembrolizumab with axitinib as first-line therapy for advanced RCC: Results from a 42-month follow-up of the KEYNOTE-426 trial (22:26) Updates on tyrosine kinase inhibitor and immune checkpoint inhibitor combination therapy and other novel agents for patients with RCC (24:07) Expert perspectives on advances in the treatment of genitourinary cancers (26:30) CME information and select publications

The San has recently welcomed to its Radiology and Nuclear medicine department a new service – Theranostics. Theranostics is a personalised approach to treating cancer using both therapy and diagnostics. The first therapy that will be used by the service is for men with advanced prostate cancer called Lutetium-177 Prostate Specific Membrane Antigen aka "Lutetium-PSMA" therapy. This therapy is used when the disease has spread, and other treatments have failed or been poorly tolerated. The theranostics service at San Radiology & Nuclear Medicine commenced in March 2021, with a dedicated theranostics area within the imaging department which will enable the dedicated team to treat up to three patients at any one time in a safe and comfortable environment. San Nuclear Medicine Physician Dr Edwin Szeto joins John Stanley.  See omnystudio.com/listener for privacy information.

PROSTATE PROS Series Finale On the last episode of the PROSTATE PROS podcast, Dr. Scholz and Liz recap important themes and talk about what’s new in prostate cancer, including Lutetium-177 and Orgovyx. Dr. Scholz: [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls. I’m your host, Dr. Mark Scholz. Liz: [00:09] And I’m your cohost, Liz Graves. Dr. Scholz: [00:13] Welcome to the PROSTATE PROS podcast. Liz: [00:15] We have a bit of a sad announcement to make, as this will be the last episode of the PROSTATE PROS podcast. Dr. Scholz and I have really enjoyed working on this project and we’ve covered so many important topics surrounding prostate cancer and men’s health. So for this last episode, we’re going to recap some important themes and talk about some promising new therapies. So Dr. Scholz, on our very first episode, we talked about how important it is to find the right treatment team. This is something that’s come up again and again and again. What are some tips you have for newly diagnosed men trying to find their doctors? Dr. Scholz: [00:53] I think what’s confusing is how much of the responsibility falls on the shoulders of patients. The prostate industry is a very powerful multi-billion dollar industry, and there is a lot happening really fast. When patients are diagnosed, they’re not in a thoughtful perspective, they’re in an action mode, they’re frightened. It is hard to sort out who to listen to and who to stay away from. This process can be aided by family members, primary care doctors, oncologists, and of course, online resources and books. I try to provide some of that information in the book, The Key to Prostate Cancer, but the process, if it was easy, we could give you one simple answer. It is not a simple process. Liz: [01:46] One thing that we’ve talked about is to get a quarterback. So this is a doctor that isn’t the treating doctor necessarily, but it’s someone that will oversee the treatment and work with the other teams of doctors. This is something I hear you doing Dr. Scholz, you’re always talking to other doctors about patients and kind of networking with them to make sure that the patient is getting the best care, even when they’re not in our office. Dr. Scholz: [02:12] I think the issue that you’re relating to is that many of these physicians have a conflict of interest. You’re asking them, what should I do? But they’re a surgeon or they’re a radiation doctor. And as a medical oncologist, I’m neither of the above. This is somewhat uncommon, but you can recruit your urologist or your radiation doctor to help you by explaining at the outset that, “you, sir, will not be my treating doctor, but I definitely need your aid and your assistance in picking the right doctor.” Liz: [02:43] Now you may be thinking that you have cancer and you don’t have time to see all these people, but as we’ve mentioned, prostate cancer is slow growing. So really taking that time to find the right doctor for you is crucial. Dr. Scholz: [02:56] Just yesterday, I saw a very sophisticated new patient who was feeling the rush job, the sense that the clock is ticking, and he did have a Gleason 9. We consider that the High-Risk category of prostate cancer. But, the idea that you have to make a decision within days or weeks is never substantiated by the literature and the science. Patients can take several months to sort out what they want to do. This sort of careful thoughtful process pays off in the long-term with better results. Liz: [03:29] So patients really need to take it under their control. One of the things is to educate themselves. In the past couple of years, there’s been a huge shift towards imaging. So we’ve had the approval of the PSMA PET scan and using 3T MP MRIs and color Doppler to help men diagnose their prostate cancer and watch it. Dr. Scholz: [03:51] What Elizabeth is referring to is that if you don’t have a clear picture of where the cancer is and whether it’s spread outside the gland, what part of the gland it’s located in, it’s not feasible to tailor treatment to the specific needs of the individual. Some men are fortunate enough to have prostate cancers residing on one side of their gland. This opens the door to something called focal therapy, enabling men to undergo treatment with less risk of erectile dysfunction. There were a lot of things we could have covered in this last podcast and the reminder that quality imaging and not only MRI and PSMA PET scans, but scans done at centers of excellence that are read by experts are going to help men be light years ahead in their selection of treatment, because they’ll have a clear picture of what they’re really treating. Liz: [04:43] So we’ve actually gotten emails from people all across the country saying, you know, my doctor’s never heard of the PSMA PET scan or my doctor doesn’t do 3T imaging. So it is really important that you take the time to educate yourself and bring these questions to your doctors. Finding the right treatment team and doing your due diligence to make sure you’re choosing the right treatment is all important because of where the prostate is located. Treatment related side effects can have damaging effects on quality of life. Because prostate cancer is so slow growing, hopefully you’ll have a very long life, so it’s important that that can be lived to the best of your ability. Dr. Scholz: [05:25] That’s so, so important. And these functions, sexual, urinary functions are something that people face every day of their life. In the hustle bustle to get treatment quickly, the fact that if the treatment is not done in an ideal way, that men can be left with permanent issues unnecessarily, certainly if there was no other option, we would live with these negative consequences. But, in most cases now with skillful care, these things can be avoided. Liz: [05:58] Over the past two years, Dr. Scholz and I have covered all the treatment options from active surveillance to surgery, radiation chemotherapy. These episodes will still be available even after the podcast ends, you can go back and re-listen and keep sharing with friends and educating yourself. Dr. Scholz: [06:16] One thing about this information provided in the podcast is not only the idea of which treatment is best and what kind of things to look out for, but the step by step process, the thinking process, the procedures, and how you can come to get the right doctors and the right treatment is implicit in the whole podcast system that we have provided. So you can also just learn from the thought process that leads to successful outcomes. Liz: [06:49] While there are a lot of challenges that newly diagnosed patients face, patients with advanced prostate cancer also are missing out on some tools like Xgeva and Prolia. Dr. Scholz: [07:01] These medicines are to help compensate for men who have disease that’s spread to their bones or men who’ve been on hormone treatment and the calcium is leaching out, a process called osteoporosis. The number of times this is overlooked and people coming to us for second opinions is really quite surprising, as they are FDA approved to help compensate for these problems. So simple second opinions can be so valuable for men, even if they have advanced disease. Liz: [07:35] As we segue into what’s coming up and what’s new in prostate cancer, we wanted to quickly mention that there are a lot of new drugs and things being tested for FDA approval through clinical trials. Clinical trials are a great way to get access to these new medications, if you have a specialist on your team who is constantly looking out for these and keeping tabs on what’s coming up. Dr. Scholz: [08:03] Every new medicine or treatment goes through a process of being researched. Once it’s validated as a treatment, it gets FDA approved. And then after that, it becomes commercialized and broadly available across the country. The things that succeed through that process are very valuable. And we’ll be talking about a Lutetium-177 and a new pill called Orgovyx. These medicines have been available, but now are commercially available. If your physician is not staying abreast of all the new developments, men who could benefit from these treatments will be denied access simply through unawareness. Liz: [08:43] Lutetium-177 is something that we’ve talked about on past podcasts. And it’s not even FDA approved yet, but you’ve actually had some patients who have had it, is that correct? Dr. Scholz: [08:57] Lutetium-177 a was purchased by a Novartis pharmaceuticals for $2 billion prior to all the testing being completed because all the preliminary data looks so favorable recently, they released the code for the large clinical trial that was performed confirming that it does prolong survival. This is a medicine that was evaluated in men with very advanced prostate cancer who had already had chemotherapy who had been on other powerful hormone treatments and they’d stopped working. The man who got treated with Lutetium-177 lived longer, statistically significantly longer, than the men who got an alternative, placebo-type approach. This medicine is well tolerated. It can cause some dryness of people’s mouths. It can lower blood counts a little bit, but it’s a simple injection every six weeks. And it is a potent treatment for men with advanced disease. It may even be a useful treatment for men with earlier stage disease. This will probably be commercially available within a year. Liz:  [10:05] To learn more about this medicine, we covered it in Episode 10, Don’t Reject Radiation.  So you can go back and listen to that.  At the end of 2020, there was a new FDA approval Orgovyx.  This is an oral anti-androgen, so it works kind of like a Lupron, but instead of it being an injection, it’s just a daily pill.  Dr. Scholz: [10:28] So how much do we really need a new pill? When if you could take an injection that lasts three to six months, and you don’t have to remember taking pills every day, but Orgovyx may have some other advantages when compared to head to head with Lupron and the other medicines like Lupron, such as Firmagon and Trelstar, Eligard, and Zoladex. These medicines all work by shutting down the production of testosterone in a man’s testicles. Orgovyx is interesting for two reasons. One is that the recovery of testosterone when treatment is stopped, seems to be much more predictable and consistent medicines like Lupron, and the others that I mentioned, can have a very protracted and prolonged effect even after they’re stopped, and it’s hard to predict when testosterone is going to return. Another thing that came out in Orgovyx trials was a lower incidence of cardiovascular complications. For years, I’ve made a strong argument that Lupron and other drugs do not cause cardiovascular problems directly, but indirectly in men who have a lot of weight gain, blood pressure goes up, blood sugars start to go out of control. Of course these things can lead to cardiovascular problems, but for some reason, in that randomized trial Orgovyx had a lower incidence of cardiovascular related issues. This is certainly an interesting and potential advantage for this medication. Liz:  [11:56] Technology and medicine around prostate cancer is improving almost daily.  And one of the things that’s really promising is immunotherapy.  We talked about this on Episode 9, The Intelligence of Immunotherapy, and we cover all sorts of different things that will benefit men with prostate cancer, like KEYTRUDA and OPDIVO YERVOY.  So if you’re interested in learning more about immunotherapy Episode 9 is a great place to start.  Making this podcast has been such a rewarding experience for Dr. Scholz and I, and we really hope that it’s helped you on your prostate cancer journey.  And we’ve left you with a little more education and knowledge and empowered you to take control of your prostate cancer diagnosis and spend time really learning about it and understanding, so you can have your medicine personalized to you.  You can find the right doctors, seek second opinions, and then take everything you’ve learned to spread awareness about prostate cancer.  Remember prostate cancer is a silent disease and it affects so many men and families and loved ones.  This really needs to be something that people are comfortable talking about.  So we hope our podcast has helped give you some points to talk about with your friends and family members and help them make those treatment decisions.   Dr. Scholz: [13:26] So Kaili, my business manager and myself are very grateful to Liz for all the hard work she’s done in compiling these episodes and helping us reach the things that really count. It’s been quite a bit of work along the way, which has been a delight to participate in for me. Liz, can you just share a couple of sentences of where you think you’re going to be going with your own professional career as you’re moving on? Liz: [13:51] Yes.  I am actually pursuing higher education to become a professional writer.  I am looking forward to it, but I’m definitely sad that I won’t be working with you and bringing this podcast to everyone.  I know I’ve had so much fun learning about prostate cancer and hopefully being able to help all of our listeners navigate this subject.  Again, these episodes have been archived, so you can go back and listen to all twenty-four of them on podcast.prostateoncology.com, or Apple Podcasts, SoundCloud, wherever you like to listen.  Another good tip is that the PCRI’s YouTube videos come out every week.  These are awesome videos that talk all about prostate cancer.  Dr. Scholz is a very frequent guest on there, so I would highly recommend you check that out.  You can find them at youtube.com/thePCRI.  Thank you for listening and supporting us.

Clinical trials are the basis of modern medicine.  Through a series of phases, clinical trials strive to find more effective treatments with fewer side effects.  For men with limited options, clinical trials can be a great way to access the newest treatments; however, choosing the right clinical trial can be difficult.  This episode discusses pros and cons of participation, how patients can benefit, and addresses some common concerns and misconceptions.  Dr. Scholz: [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls. I’m your host, Dr. Mark Scholz. Liz: [00:09] And I’m your cohost, Liz Graves. Dr. Scholz: [00:13] Welcome to the PROSTATE PROS podcast. Liz: [00:17] Clinical trials are the root basis for modern medicine and they’re vital for the development of new treatments. This episode, we’re going to talk about pros and cons of clinical trials, who can benefit, which clinical trials to be most excited about. We’ll also address some concerns patients might have about participating. Dr. Scholz: [00:37] Yeah, I mean, clinical trials are how doctors decide what to do for patients. But today we’re going to talk more about how patients can extract a benefit from participating in a clinical trial. Some medicines are only available on clinical trials, they’re not FDA approved yet and trying to make a determination if you, specifically, would benefit by being in a clinical trial, getting an investigational drug is what this podcast today is about. Liz: [01:05] So which type of patients in prostate cancer are looking for clinical trials? Dr. Scholz: [01:11] It’s really important as has been emphasized many times in the past, that there are different types of prostate cancer. We call them stages or five different stages of prostate cancer and clinical trials are usually being performed in people with advanced metastatic prostate cancer, more often the type of cancer that is not responding to traditional medicines. Liz: [01:34] So these are patients who have limited options left and clinical trials can allow them access to the newest treatments. Dr. Scholz: [01:42] Exactly. The problem with doing clinical trials is that there are always disadvantages. If there are other FDA approved medications that have been already shown to prolong life why wouldn’t patients use those first, especially since they are typically covered by most types of insurance? Liz: [02:05] I think one concern people have is that clinical trials are either not covered by insurance or they’re expensive. Is this true? Dr. Scholz: [02:12] Actually no, most of the time, clinical trials will provide the medications free of charge. I think the disadvantages of clinical trials are that they’re somewhat cumbersome, there’s a lot of paperwork, and it’s very formalized. So people are treated in a very uniform fashion, there’s less room for creativity and adjustment of doses and things like that. There’s a major inconvenience to clinical trials. Then of course the way that the medicine is used or whether or not there is a potential for getting placebos, these things can also be a disadvantage for patients who are participating in clinical trials. Liz: [02:50] I think one other thing I was looking at clinicaltrials.gov to find the list of what’s happening in prostate cancer. A lot of the eligibility criteria is really strict, so I think that can be kind of a limiting factor as well. Dr. Scholz: [03:05] Yeah, that’s a very good point. If people don’t meet the criteria, then they can’t enter into the trial. I think it’s challenging for patients to parse out, do they have the eligibility criteria that will qualify them? It’s not easy to read these trials and it’s not like you can learn a trial and now you understand trials, every trial has its own unique design. So the patients that are going to be able to utilize the vast industrial, investigational complex are those that can get online, read trials, and understand the eligibility criteria to determine if they would fit into that trial. So it’s a shame to waste a lot of time, understanding the pros and cons of a trial only later to learn that you don’t qualify. Maybe you’ve had one too many rounds of chemotherapy or some other factor that kicks you out. The typical problem is that these trials are not flexible. Because you’re a nice guy they’re not going to give you a card to get into the trial. You must fit the criteria. Liz: [04:10] So clinical trials are another reason that you should be knowledgeable about your health and maybe have copies of your medical records. You can reference those to see if you can fit into a trial. How do patients decide if this is even something they want to pursue? Dr. Scholz: [04:26] Well, as you mentioned previously, Elizabeth, the patients that have good options and there’s thankfully a number of good options for men with advanced prostate cancer now probably should go with those first. But it’s always good to have a backup plan. Many treatments will not work indefinitely and when things are going well, it’s good to be looking into what you would do if the treatment you’re using right now stops working. Your doctor may have a clear plan and it may make perfect sense with drugs that are already FDA approved, if he hems and haws and says, “I don’t know exactly what the next step would be,” perhaps now it’s time to start looking into whether you would be eligible for some of the different clinical trials that are out there. Liz: [05:12] So we’re talking about men who have limited options. On an earlier episode, we talked about off-label therapy and some of these clinical trial drugs can also be used in an off-label way. How do we decide if patients should go the clinical trial route, or if they should get the drug off-label? Dr. Scholz: [05:32] It may have to do the cost. Sometimes the clinical trial will cover the cost of these expensive medications or maybe convenience. It’s more convenient to simply have your doctor prescribe a medication, which he can legally do using his own judgment. If it’s FDA approved somewhere for another cancer, perhaps. This brings up the whole subject, which we’ve covered in the past of genetic testing as a way to determine if an off-label medication might fit for a patient, who’s got limited options otherwise. Liz: [06:08] So whether someone’s using the drug in an off-label way, or they’re on a clinical trial will you be checking their PSAs and just making sure their side effects are kept in check? Dr. Scholz: [06:20] Precisely. The issue is with any treatment for men with advanced prostate cancers is we really want results. The type of people that are going into clinical trials have often tried a few different things and they’ve stopped working. So we don’t have time to dilly dally around. We need results. That usually means a decline in PSA once the treatment has started, or if people are having some bone pain that the bone pain goes away, some clear evidence for benefit. This seems kind of obvious, but it surprises me sometimes that patients will patiently wait on a medicine, even though the PSA is steadily rising month after month, when really it’s time to move on, if after two or three months there isn’t evidence for a response. Liz: [07:00] That’s actually something I learned while researching this is that patients can stop clinical trials at any time, if they’re not responding, or if they’re having bad side effects, you’re not locked in to the clinical trial. Dr. Scholz: [07:13] Yeah. Excellent point, because even though this is research, ultimately ethics demands that patients be treated in a fashion that’s going to benefit them and not leave them worse off than they started before. Liz: [07:27] So there are different phases of clinical trials and each has kind of a different set of requirements. Can we start talking about phase I trials? Dr. Scholz: [07:36] Yeah. So phase I, II, III, and sometimes even phase IV. Phase I is a brand new medication, so new, no one knows what the proper dosage is. The only way to learn is by giving steadily increasing, incremental amounts to different patients to see, at what point did they start developing side effects? So patients that are participating in phase I trials typically are, I would guess more desperate because there’s no proof yet that it’s going to work in humans. There’s probably been studies in animals, or other factors that indicate possible benefit, but phase I trials are dose finding trials. If you are planning on going into a phase I trial, you really want to ask the investigator, have they tested it in other people yet? Are there any signs that it’s causing benefit and have they started to see any side effects? For safety reasons they usually have to start at a very low dose, or if you’re the first patient to go onto a phase I trial, there’s a good chance that the dosage will be too small to benefit you. Liz: [08:41] After a phase I trial is completed and successful. Then next comes phase II. Dr. Scholz: [08:48] Phase II trials are for patients who are going to be getting a drug that in a phase I trial was shown to be somewhat effective and also not excessively toxic. So the advantages of a phase II trial are that people will be getting the proper dosage of the medicine. It’ll be with a medicine that we think has activity. Another good thing is that everybody gets the medicine. As we move on to talk about phase III trials, we get into the whole issue of placebos. Liz: [09:18] Okay. So phase III trials grow a little bit larger and you’re either comparing the new drug to the standard treatment, or they’re randomized with placebos, as you just said. Dr. Scholz: [09:29] So phase III trials are usually pretty exciting because the phase II trials showed a benefit and phase III is necessary for the FDA to approve a drug for legal use in the United States. Therefore the medicine that’s being used is very likely to be helpful. The problem of course, is the risk of getting randomized to a placebo. That is obviously a concern. Sometimes they randomize people two-to-one. So your chances of getting the real drug are two-thirds. The chances for getting the placebo is one-third also, if you embark upon one of these trials and there’s a known set of side effects with the investigational drug, you can sometimes discern if you are getting the real drug or not, because the placebo patients aren’t getting any side effects whatsoever. If there’s a response, clearly you’re getting the real drug. So patients do have the option of stopping the trial, if when they’re taking the placebo, they feel they’re receiving no benefit. Liz: [10:31] A lot of the apprehension around clinical trials comes from this idea of getting the placebo. And as Dr. Scholz just mentioned, this likelihood really only increases in the phase III trials. How do you talk about this with your patients? If you have someone coming to you saying “Dr. Scholz, I really want to participate in this phase III trial, but there’s a chance I’m getting the placebo?” Dr. Scholz: [10:54] Like any other treatment decision we’re looking at risk benefit ratios, we’re looking at what other options do we have? What is the chance at some other second or third line treatment option is going to benefit versus the investigational drug? Sometimes these investigational drugs come into phase III with tremendous optimism. There’s a medication called Lutetium-177 that has just recently completed phase III trials. But in the phase II trials, 30, 40, 50% of patients were responding to this with very few side effects. So there was no doubt that this medication was beneficial. And of course one’s best hope is that you get the medication rather than be randomized to the placebo. But other phase III trials were not so certain that the drugs are effective. Those obviously are less attractive. Liz: [11:45] All the medications that are used today, like Taxotere, abiraterone have all been through these phases of clinical trials, but there are a number of medications that never made it into the medical world because they failed at these clinical trials. Dr. Scholz: [12:02] I would say that for every medication, FDA approved that we have in prostate cancer, there’ve been five, ten, or fifteen clinical trials that were just as optimistic and hopeful, but did not show a survival advantage when they were tested thoroughly in phase III trials. We mentioned this because there’s often a false sense that if it’s in a clinical trial, it’s new and improved and it’s going to be better than what’s on the market already. I think that is becoming more common. I think medical research is improving every year and the hit rate on these drug designs is getting to be quite good, but patients need to be careful that just because it’s in a clinical trial, doesn’t mean that it’s going to turn into an effective drug. Liz: [12:49] So our office does clinical trials. How are you deciding which one of these seem like they will actually help your patients versus which ones you’re just going to pass on? Dr. Scholz: [13:01] I remember when a drug trial looking at high-dose vitamin D in combination with Taxotere was put on a phase III study and there was so much excitement because all the phase II trials look so good and everyone is already excited about vitamin D, but unfortunately it did not pan out. The high doses of vitamin D with Taxotere gave somewhat lower response rates than the patients who got Taxotere alone. Liz: [13:31] There are also phase IV trials, which are observational trials, looking to learn more about the drug after it’s already on the market. Dr. Scholz: [13:40] So the types of questions that pharmaceutical companies ask are in a larger number of patients, once it gets on the market, thousands of people will be undergoing therapy. Are there other rare side effects, for example, that need to be tested for? And the idea is that further experience with how the drug behaves in a larger population could be useful. Liz: [14:05] If you’d like to see what clinical trials we’re conducting at our office, visit prostateoncology.com. Which current prostate cancer trials are you paying particular attention to? Dr. Scholz: [14:18] Right now, most of the excitement is around immunotherapy. People have heard about these medications, President Carter had an amazing miraculous response to a medicine called KEYTRUDA, which stimulates the immune system. There are three phase III trials looking at KEYTRUDA in various combinations for men with prostate cancer. There’s also some work being done by Amgen, which tries to garner people’s T-cells to attack cancer directly. They use a bi-specific monoclonal antibody to attract the army cells of the immune system, the T-cells, closer to the tumor to kill off the cancer. Some of the early phase II trials look pretty exciting. The whole field of immunology is so hopeful. We know that we’re only at the beginning and if we can develop this technology and harness it, it’s going to benefit a lot of people. Liz: [15:15] There are so many clinical trials that it’s often hard for doctors to keep up with them all. So this responsibility falls on the patient’s shoulders. Clinicaltrials.gov is a great place that’s organized, and you can find information there and then bring that information and have a conversation with your doctor. Dr. Scholz: [15:35] If you understand your stage, you can look at the eligibility criteria and only be looking at the trials that would fit your profile. Also, you know what limitations you have. Can you travel to a different town? Are you willing to go through the hoops that are necessary and the inconveniences to get into a clinical trial? Once you select some potential candidates, your physician can help you decide if it’s really a practical approach. Liz: [16:04] One last thing to note is we’ve talked about how biased the industry is and unfortunately clinical trials are no different. Dr. Scholz: [16:13] So the industry of clinical trials is heavily funded by the pharmaceutical companies. I’m extremely grateful for these wonderful new medicines that these companies put in my tool chest to help patients with. But there’s a tremendous urgency to get patients involved in clinical trials. They’re very expensive to run. You as a patient have to be careful that you’re not being hurried into a trial that really doesn’t benefit you. There’s always that potential that any warm body may fit. And if you are a savvy shopper, you can take advantage of these wonderful new drugs. But, if you’re not careful, it is possible for you to end up receiving medications that are very unlikely to help. Liz: [16:56] As always, it’s important to stay empowered and be proactive about your prostate health. We’ll keep you updated on the subject as more clinical trials emerge. Thank you for listening. Remember to email any questions or topics to podcast@prostateoncology.com.

This episode of PROSTATE PROS reviews and summarizes the year’s advancements in prostate cancer as well as looks forward to future updates. Beyond prostate cancer, the episode examines how COVID-19 has impacted the healthcare landscape and discusses news of the vaccine. Catch up on the latest and stay tuned for an exciting announcement. Liz:  [00:00] We have an exciting prostate cancer update.  Since recording this episode, the FDA recently approved the PSMA PET scan.  Keep that in mind when listening to the episode.  If you’d like further information, visit fda.gov. Dr. Scholz: [00:18] We’re guiding you to treatment success and avoiding prostate cancer pitfalls. I’m your host, Dr. Mark Scholz. Liz: [00:24] And I’m your cohost, Liz Graves. Dr. Scholz: [00:28] Welcome to the PROSTATE PROS podcast. Liz: [00:31] A lot has happened this year and we’ve covered many topics on the podcast. This episode we wanted to highlight a couple of exciting advancements and talk about some updates. Dr. Scholz: [00:44] The elephant in the living room of course, is the COVID situation. That’s impacted the way we do business. It’s impacted our patients. It’s impacted all of you dramatically. I thought I’d give a little update on what’s happened in our over 2000 clients. As you know, we serve a population of men between fifty and ninety plus our oldest patient just turned one hundred. This is a high risk group. Men are at higher risk for COVID complications and as we get older, particularly over 80, the complication rate goes up and the mortality rate goes up. We’ve actually lost one patient to COVID in our whole practice in 2020. It was an unfortunate individual that was traveling in Egypt in the January, February timeframe and when he came back to the United States he was ill. This was before people were really clear of what was going on, went to the hospital with pneumonia, and unfortunately passed away. We’ve had other patients, perhaps a dozen or so that have caught the COVID. They’re sort of evenly divided between men who really report that it wasn’t much of anything at all and others, the other half, they got pretty darn sick, a really bad flu. None of them fortunately had to go to the hospital. They all recovered. This is rather remarkable considering our vulnerable demographic. It shows that if people are careful and they isolate, they wash their hands, keep their hands off their face, most people aren’t going to catch this. Of course, when I talk to patients, I’m impressed by how much isolation is going on out there, how much care they are taking. Many men have come to the office and said that I am the first out of the house experience that they’ve had in 2020. So people are being very careful and clearly being careful does work. Liz: [02:49] Yeah. I remember early on in the pandemic, our office had way less traffic and was almost empty. Now it seems like things are picking back up and people are checking back in on their health. Dr. Scholz: [03:01] We’ve had a bunch of people come to the office who maybe had some cold symptoms, everyone’s on edge, and we’ve tested them for the COVID antibody to see if they did indeed have previous exposure. These tests are almost always coming back negative. We’re told by the scientists that these tests are probably 80% to 90% accurate. They’re not 100% accurate when you do the antibody test. That’s the test to determine if you’ve had previous exposure to COVID. We believe, and some people disagree, that if you’ve had previous exposure and your antibody test is positive, that it’s as if you’ve had a vaccination and you can’t catch COVID and you can’t transmit it. That of course would be good news. We’ve tested several hundred people now and almost all of them are negative. The ones that are positive are the ones that told us previously that they knew they had COVID. These antibody tests confirm it. This is a different test than the nasal swab, where doctors are trying to determine if you actively have the COVID virus. Those tests are more accurate, perhaps approaching 99% accurate. Patients who think that they have symptoms need to find a place to get tested, to rule in or rule out whether they are infectious. After they’ve been sick, they want to be tested again, to make sure that the infection risk has gone away. Liz: [4:38] We’ve had inquiries about where to get tested. We usually just send whoever across the street to Cedar Sinai, and they’ll do it there. The turnaround on these test is quick enough that people can just wait for their results and they should know within an hour. All right, Dr. Scholz, I think the biggest information about COVID right now is news of a vaccine. I think one thing a lot of people are concerned about is how quickly this has developed vaccines usually take years, if not a decade to get developed. This has happened within a year, which is pretty incredible. Do you think it will be safe? Dr. Scholz: [05:15] So there’s been debates, everyone’s heard them, that will the vaccine work, will it have durability? At this point, the preliminary science suggests that it will work and it will have durability. There’s three different companies that are putting forth a new product. The hope is that by the end of the year we will be having people getting vaccinated. Of course, there’ll be selective preference for the elderly people in healthcare. How this is all going to roll out is a big question. But it seems at this point, there’s no doubt that by early 2021 a vaccine is to be available and it will be effective. Liz: [06:00] It is changing really quickly. I know we were just talking about this last week and when I went back to review, I almost had to research it all again. So it’s important to stay up to date on this. Dr. Scholz: [06:14] Yeah everything that we do in the oncology realm and in this realm as well is predicated on what we call a risk-benefit ratio. We give dangerous medicine sometimes in oncology, but we are treating life-threatening cancers and sometimes rolling the dice and taking a chance with a treatment makes a lot of sense if the disease is much worse and very dangerous. So it’s going to be different for different people, for myself as a physician, meeting people all day long and basically in a high-risk situation, it seems to me that I’ll be lining up early for the vaccination. For those of you out there that are comfortable in your isolated state and are willing to sustain that, 2020 showed us that people can remain pretty safe if they’re very careful, but the social isolation is taking a big cost in our patients’ mentalities, their lifestyles, their social lives. It’s been painful and difficult when people have to make a personal choice as to whether the relatively small risk of getting a vaccine is too great to consider as opposed to continuing in their existing lifestyle. We’ll have more information every month as this vaccine rolls out as to how dangerous or how many risks there’ll be associated with it. That is unknown at this point. But as a lot of people are going to be getting this vaccine, we should have very good information within a few months. I think one last thing to emphasize is that we’ve learned that the COVID virus complication rate goes up astronomically in men over 80. Men over 80 and the elderly are at the very highest risk and mortality rates start to become very significant in this group. It would seem to me that these elderly men are going to want to try and get a vaccine, even if there are some risks associated with the vaccine, because the virus for them is very dangerous. Liz: [08:22] So another paradigm shift that occurred this year was the shift towards telehealth. It seems like about half of our visits now are being conducted over the phone or via FaceTime or Skype. Dr. Scholz: [08:36] This has been a really big change. In trying to understand it and wrap my brain around it, it seems that it’s a radical shift in accessibility. In the past, phone visits were discouraged because the impetus was to get people into the office and be able to bill for your services. Now, both private and Medicare insurance has essentially mandated insurance coverage for telehealth. This has rapidly been accepted by patients due to the accessibility, the ease of communication. It’s even been nice to be able to take off my face mask and see the body language of my patients and communicate non-verbally with Skype and FaceTime. In the office employees, patients alike are all wearing masks and we’re making eyes at each other, using our voices and trying to overcome the muffled communication that has become routine now in our lives. Liz: [09:44] I think something else that the telehealth has brought is connection. Right now people are feeling kind of anxious and separated. If they are skipping doctor’s appointments to avoid waiting rooms and being close to other people, it’s such a great way to catch up on the latest in prostate cancer and catch up with you. Your face appears in their living rooms and it’s like they’re right in your office. Dr. Scholz: [10:10] Yeah it is very personal. It’s as you all have experienced now, your face fills the screen and it’s not as disconnected as people might think. The risk to patients with telehealth is obviously reduced. But one component of the way we do medicine, of course, is blood tests, injections, and treatments, and certain in office visits are still unavoidable. If patients go to a remote facility for blood testing, they’re still going to have some contact. But so far as has been demonstrated, the COVID infection rate for our patients has been very low, whatever precautions people are taking seem to be working quite well. One thing about telehealth is it appears to be here to stay. I’ve talked to high-level insurance people about the future of telehealth asking, will it go away once the COVID risk disappears? The general consensus is that there’s no going back. This increased accessibility seems to be the future of medicine. Liz: [11:19] So even big topics that are maybe a little more involved or confusing are easily addressed over Skype or FaceTime or a phone appointment. Let’s start talking about a couple of those that are new developments for 2020. Dr. Scholz: [11:34] We already covered PARP inhibitors but they, being brand new treatments for advanced prostate cancer, merit a quick review. PARP is an enzyme that helps repair DNA. About 10% to 15% of men with advanced prostate cancer have a mutation that causes their DNA repaired to work less efficiently. One application of this mutation, which is called BRCA, is that there’s a little higher risk of getting prostate cancer. The men who get prostate cancer that have BRCA tend to have a more aggressive form. The PARP inhibitors exploit this mutation and men that have this mutation respond much, much better to PARP inhibitors. PARP inhibitors are pills that make it even more difficult to replicate or duplicate DNA. These already impaired cancer cells then die more easily and more quickly than your normal cells of your body. We’re always looking for a differential effect with cancer treatments, a treatment that focuses more on the cancer, then your cells killing cancer without causing a lot of side effects. So the medicines we’re talking about are Olaparib and Rucaparib two new pills that help men with BRCA mutated cancer and are now FDA approved. Liz: [13:01] These two approvals really highlight how important using genetic testing is. This will help men with prostate cancer find treatments that may have only been FDA approved for another cancer. Doing genetic testing is very easy. It can be accomplished with a mouth swab or a blood test, and it’s almost always covered by insurance. So we briefly covered some updates and genetic testing. Let’s review the PSMA PET scan really quick. Dr. Scholz: [13:32] We did a whole podcast on this because it’s a big breakthrough. Most of you have heard of it by now, but for the first time we can accurately locate the prostate cancer wherever it is in the body and the prostate and the lymph nodes in the bones with one single scan. This scan may be five times more accurate, ten times more accurate than any previous scan that was available. What a wonderful addition to our diagnostic armamentarium. This is going to have an impact for people with early stage disease, late stage disease. Unfortunately, the FDA has not yet approved it, but we’re anticipating approval within the next six months or so. In that situation, it will be covered by insurance and it will be very popular. Liz: [14:18] Some companies are investigating using PSMA as a therapeutic target rather than just a diagnostic target. Dr. Scholz: [14:28] Exactly. So the diagnostic scanning is incredibly useful reconnaissance for figuring out where the cancer is and helping design a treatment protocol. But if we’re able to accurately locate the cancer with these scans, wouldn’t it be possible to use this same target, to make therapies stick to the surface of the cancer cells? There are two very exciting types of treatment. One we’ve talked about before uses an antibody to stick to PSMA and draw a high energy radioactive molecule right next to the cancer cell and kill the cancer cell. This is called Lutetium- 177. The phase three trials in prostate cancer have been completed. We’ve had patients on trial or outside the country, get this treatment with very nice responses. We’re talking about a treatment for men that have already had chemotherapy, become hormone resistant to Zytiga and Xtandi, and who perhaps have limited treatment options getting nice PSA declines with relatively little, if any, toxicity. There is a PSMA antibody on the salivary glands, so some people get a little bit of a dry mouth. Some people with radiation, it can cause some lowering of blood counts, but for the most part, there’s practically no side effects with dramatic responses to Lutetium-177. The phase three trials are completed and they’re waiting for them to mature to validate that there is a survival advantage. Once that happens and the study results are released, the FDA has six months to approve or disapprove the treatment for broad spectrum dispersal amongst the population for therapy and insurance coverage. Liz: [16:14] So it seems like there’s a lot to look forward to with PSMA being used as a diagnostic test as well as its role in therapeutics, especially for men with advanced prostate cancer. There are a couple immunotherapies that are exciting on the horizon. Can we talk a little bit about those? Dr. Scholz: [16:36] Amgen has developed a connector molecule that instead of linking a radioactive moiety to the antibody that clips to PSMA, it’s sort of like a pheromone tag that draws in your T-cells. I don’t know how many of you are familiar with how the immune system works, but the soldier cells of the immune system are called the T-cells and the T-cells are the component of your immune system to go in and attack the cancer cells and kill them directly. Theoretically, if you can get the T-cells in close approximation with the cancer cells, they will attack and kill them. There is new technology from Amgen, a very large pharmaceutical company, that has developed this and is doing phase two testing in men with advanced prostate cancer and responses are indeed occurring. So the patients are injected with a substance that clips onto PSMA i.e. the surface of the cancer cells and draws the patient’s immune system close to the cancer cells so that it will attack it. Liz: [17:49] As you can see, there’s so much information about prostate cancer this year alone, we’ve covered focal therapy, brachytherapy, radiation, immunotherapy, chemotherapy; the list goes on and on. So looking forward, it’s important to always stay in touch and stay up to date and keep sharing and keep listening. You might find it useful to go back and review old episodes of PROSTATE PROS. You can find us on your favorite player. So Dr. Scholz, another exciting thing 2020 was the 10th anniversary of your first book Invasion of the Prostate Snatchers. Something you may not know is that this year, Dr. Scholz and I have been working hard to update his first book Invasion of the Prostate Snatchers. So about 10 years ago, when the first edition was published, it was really the first introduction to active surveillance. I think Dr. Scholz received a little flak from that, and now it’s more widely accepted, but with that, there’s still a lot of the industry that patients need to be careful of. That includes over-treatment. That includes dangers of surgery and random biopsies. So we’re really looking to restart the conversation, and get patients to be their own advocates. Dr. Scholz: [19:16] There’s a theme in the prostate cancer world that you have to educate yourself. I hope that both of my books encourage people to do their own research, to take responsibility for their health and to double check the information, rather than just accepting the first pitch you hear from a doctor. Prostate cancer is big business. It’s a multi-billion dollar world, and people are trying to make a profit. Ethically, no doubt, there’s so many gray areas in the prostate cancer world. You need to double-check and you need to find the original, basic information that leads you to the truth. Liz:  [19:59] So this new completely rewritten second edition of Invasion of the Prostate Snatchers will be out in 2021.  We’re really excited to share it with you.  Telehealth has really connected us this year, and we’re looking forward to staying connected in 2021.  Remember to tune into the podcast and share with your friends.  If you have any topics you want us to cover in the upcoming year, you can email us at podcast@prostateoncology.com.

Let us ensure we remember the lanthanide series before we leave it behind once and for all.

ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so clinical trials described here may no longer be enrolling patients, and final results are not yet available.   Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. In today’s podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, bladder, and kidney cancer. This podcast will be led by Dr. Sumanta (Monty) Pal, Dr. Neeraj Agarwal, Dr. Petros Grivas, and Dr. Tian Zhang. Dr. Pal is co-director of City of Hope's Kidney Cancer Program and is the head of the kidney and bladder cancer disease team at the institution. He has served in a consulting or advisory role for Novartis, Genentech Roche, and Bristol-Myers Squibb. Dr. Agarwal directs the Genitourinary Oncology Program at the Huntsman Cancer Institute at the University of Utah. He has served in a consulting or advisory role for Novartis and Bristol-Myers Squibb. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine. He is also an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He has served in a consulting or advisory role for Genentech Roche and Bristol-Myers Squibb. Dr. Zhang is an assistant professor of medicine at Duke University School of Medicine and is a medical oncologist at Duke Cancer Institute. She has served in a consulting or advisory role for Genentech Roche and Bristol-Myers Squibb. View full disclosures for Dr. Pal, Dr. Agarwal, Dr. Grivas, and Dr. Zhang at Cancer.Net. Dr. Pal: Hi, I'm Monty Pal from City of Hope. I'm the Associate Editor for Genitourinary Cancers for Cancer.Net, ASCO's patient education website.  I'm really excited to be here with my colleagues: Dr. Petros Grivas, Dr. Neeraj Agarwal, and Dr. Tian Zhang. We're really excited about this effort. We're hoping it brings some salient details about clinical trials straight to you, our most important audience. Keep in mind that clinical trials are the main way that doctors are able to find better treatments for diseases like cancer. And before any new drug can be approved by the FDA, it must be studied in the context of a clinical trial. Patient participation is vital for clinical trials. By participating in a clinical trial, you can directly help researchers develop better treatments, reduce side effects, or even reduce the risk of cancer altogether. While you may receive new treatments within a clinical trial, the primary purpose of these studies is to move the field of cancer research forward. Keeping participants safe is probably the most important concern in clinical trials, and there may be some risks involved. Because of that, your healthcare team is going to discuss with you in detail these risks before you join on to a clinical study. Now, at this point in time, we're going to discuss 3 studies that are being done in the area of kidney, bladder, and prostate cancer. These studies were chosen by members of the Cancer.Net Editorial Board Genitourinary Cancers panel from the Trials in Progress abstracts that are going to be presented at ASCO's 2020 Genitourinary Cancers Symposium. I'd like to note that none of us have any direct involvement with any of these trials. Each one of us will post our disclosures on the ASCO website if you'd like to see them. We'll certainly have them posted on the Cancer.Net website. I'd like to begin by introducing my very esteemed panel.  First, is Dr. Tian Zhang, who's an expert in kidney, bladder, and prostate cancer from Duke Cancer Research Institute. We have Dr. Neeraj Agarwal, who heads up the Genitourinary Cancers Program at the Huntsman Cancer Institute at the University of Utah. And last, but not least, we have Dr. Petros Grivas from the Fred Hutchinson Cancer Research Institute in Seattle, Washington, an expert in many disease types, including bladder cancer. I'd like to bring on my first guest, Dr. Neeraj Agarwal, to discuss the VISION study. [VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)] Neeraj, this is a study in prostate cancer. What particular patient population within prostate cancer are we focused on here with this study? Dr. Agarwal: So this is a patient population with advanced prostate cancer where prostate cancer has gone beyond prostate to different parts of the body. In technical terms, we call it metastatic prostate cancer. The usual treatment paradigm for these patients is to be treated with hormonal blockade therapies, which can include injections and oral pills, which have different mechanisms to prevent stimulation of testosterone to the prostate cancer cells. However, every patient with metastatic prostate cancer eventually are failed by these treatment options, and the next commonly used treatment option is chemotherapy, which usually controls the disease for a period of many months, up to one year. And after, patient's disease progresses on these 2 different therapeutic options, which include hormonal therapies and chemotherapies. And this is the patient population in which this novel type of radiation therapy or radiation particle treatment is being tested. Dr. Pal: Tell us about what question this study aims to answer. Dr. Agarwal: This study is testing a novel medication, which is a type of a radiation particle, which is supposed to target prostate cancer cells. So whether using this kind of radiation particle in patients with advanced prostate cancer, who have been failed by previous chemotherapy and novel, hormonal therapies. The study is asking whether using this radiation particle as a treatment may improve overall survival. Dr. Pal: Now, this compound is called 177Lutetium-PSMA-617. It's a long name. Tell us about what it actually does. What's the rationale for using this particular drug? Dr. Agarwal: I would like to divide this long name into 2 parts to make it simple. So 1 is the lutetium particle, which is the radiation particle, is a type of radiation known as beta radiation. So lutetium is tagged onto a PSMA-identifying agent known as PSMA-617. So if we just inject PSMA-617, it will go and seek prostate cancer cells, which are expressing PSMA on their surface. If you tag this radiation particle lutetium to the PSMA-617, what essentially happens is that PSMA-617 takes this radiation particle directly to the prostate cancer cells. Dr. Pal: Now, what is this study attempting to demonstrate? Dr. Agarwal: This study is specifically looking at 1 question, which is whether using this radiation particle can improve survival in patients with metastatic prostate cancer who have had disease progression on novel hormonal therapies and chemotherapies. Dr. Pal: And again, it's hard to be comprehensive in a podcast like this, so of course, we refer patients to their physicians for a discussion around safety of these drugs. But could you tell us about any known risks that patients should be aware of in the context of this agent? Dr. Agarwal: Yes. So as you can imagine, this PSMA-617, which is loaded with this radiation particle, is looking for those cells in our body which are expressing PSMA. So of course, the PSMA is expressed highly by prostate cancer cells. But there are also normal cells which express PSMA to a lesser degree. And those cells may also have the potential to be targeted by this radiation particle. So technically, their other cells which may express PSMA, or which are in the vicinity of these cancer cells in the bone, such as bone marrow, these can be targeted to a much lesser degree because of the specificity of this compound. We can see some off-target toxicities, as we call them, but given the highly targeted nature of this compound, those toxicities are usually very well tolerated, except in rare circumstances. Dr. Pal: Excellent, Neeraj. Now, for a little additional commentary on the VISION trial, I'm going to throw it to Dr. Tian Zhang, again, an expert at the Duke Cancer Research Institute Tian, you've had some experience enrolling patients on VISION, correct? Dr. Zhang: That's right, Monty. Thanks so much for having me on. And VISION has actually completed accrual. It was open for a few months here at Duke. We were able to enroll about 10 patients and we're really looking forward to seeing the results of VISION over the next year or 2. And I think it'll be quite applicable to clinical practice. Now, I want to mention that although VISION has completed enrollment, there are other clinical trials that are using PSMA-targeted Lutetium-617 agent as a possibility for other patients to enroll on to other trials in clinical development as we speak, and so there will be other opportunities to receive this agent. Dr. Pal: We're going to shift gears now from prostate cancer and move on to the topic of bladder cancer. And again, I'm thrilled to have Dr. Petros Grivas from the Fred Hutch Cancer Research Institute to discuss a very important trial called INTACT. [Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)] Petros, the study INTACT really addresses a very important question. Can you tell us a little bit more about it? Dr. Grivas: Thank you, Monty. I think this trial is very important for a number of reasons. Number 1 is trying to address an important clinical question, which is the following: Patients who we consider candidates for bladder-preservation approach, meaning, we try to keep the bladder in place and still kill the cancer, which is not a good option for everybody with bladder cancer. But the proportion of patients after discussions of pros and cons with their providers could be offered this bladder-preservation approach, which is consisted of an optimal resection of the tumor through a procedure called transrectal bladder tumor resection, which means try to remove the bladder tumor through a procedure that is similar to cystoscopy, when you look inside the bladder. And after this tumor is removed, then there is a combination of chemotherapy and radiation, at the same time—we call this concurrent or concomitant—at the same time, chemotherapy and radiation. This approach, which involves the collaboration between the urologic oncologist, medical oncologist, and radiation oncologist, is the standard of care, the standard approach, how we try to preserve the bladder and still kill the cancer in those patients who are considered good candidates for this approach, which, as I've mentioned, is not for everybody. The clinical question is can we improve upon this backbone of chemotherapy and radiation, which is current standard of care, by using a third modality, a third type of treatment, which is immunotherapy? And immunotherapy is known to improve how people live in patients who have metastatic bladder cancer. For example, there's this particular drug called atezolizumab, which is already having FDA approval for patients with metastatic bladder cancer. The question is can we add this drug, the immunotherapy drug, that is activating the immune system, into the backbone of chemotherapy and radiation and use all three approaches, chemotherapy, radiation and immunotherapy together? And if that's the case, is that triplet combination better or not to the current standard of care, which is chemotherapy and radiation? So the INTACT trial is chemotherapy, radiation, plus immunotherapy with this drug called atezolizumab, together, all 3 of them compared to chemotherapy and radiation alone, in order to see whether we can improve upon the results we're getting with chemotherapy and radiation. The primary end point of this particular trial is what we call bladder intact disease-free survival, which means the proportion of patients who have no cancer coming back after treatment. They have what we call a complete response, remission of the cancer, and they still have the bladder intact, in place. And this is what we call a metric of success. This is a huge effort among different investigators across the country. These studies open in multiple cancer centers and sites across the nation. And I think it's a very good example of what can happen in terms of a clinical trial design that is applicable to many patients when different collaborations take place and when people put their minds together. So we're really very enthusiastic about this study, and we'll try to support the accrual and offer this option to the patients who are considered to be good candidates for this attempt for bladder preservation. Dr. Pal: Petros, thanks. That was a great overview of the study. You've really highlighted the rationale and some detail and the metrics for success of this trial. Now, on the subject of this approach, are there any risks that you think patients should be particularly aware of? And again, we leave it to the discretion of treating physicians to have that very thorough discussion of risks and benefits. But off the top of your head what would you counsel patients, in general? Dr. Grivas: I think, Monty, that's a great question, in general, because when a patient is undergoing evaluation for a clinical trial, it's important for them to understand thoroughly the pros and cons of this particular therapy and other procedures and what those mean for the patient's logistical, day-to-day schedules, as well as potential short-term and long-term side effects. In that particular study, I think the important take-home message is we're trying to evaluate the additional role of immunotherapy to the backbone of chemotherapy and radiation. So potential side effects of immunotherapy are something that are very important to be discussed with the patient. Some of the patients may develop fatigue or some degree of occurrence of what we call immune-related adverse events, which means the immune system gets activated, stimulated against the cancer but can, potentially, in a small proportion of patients generate a significant reaction, an immune system activated related reaction against different parts of the body or some parts of the body. So I think it's very important for the patients to discuss carefully with the providers what are those uncommon, but sometimes significant, immune-related adverse events, and have a very good understanding of what symptoms [to] look for in order to be able to communicate or recognize early those potential side effects and have a proper management plan. Because most of those side effects could be managed properly, and with good success, especially if they're caught up early. So I think it's important to have these thorough discussions with the provider. And of course, the side effects of chemotherapy and radiation should be discussed in thorough detail. This is the standard of care, but still is important to delineate what potential side effects can happen. At the end of the day, it's in the balanced discussion about pros and cons. This is a very exciting trial, but I think good education for the patient and their families and their caregivers are very important and critical for the successful detection or diagnosis of any potential side effects. Overall, I think this is a very relevant discussion to have with the provider and a very exciting trial to be involved in. Dr. Pal: Excellent, Petros. Well, great discussion of some of the risks associated with this approach. Neeraj, any thoughts on INTACT? Why should patients be excited about this particular trial? Dr. Agarwal:  I was recently talking to one of my patients about this upcoming trial, who is preparing to go on radiation therapy plus chemotherapy as a treatment option for his muscle-invasive bladder cancer, and cystectomy is not an option. And the way I explained this to the patient is 95% of the work he will have to do will be done by the time he's getting radiation therapy and chemotherapy. And after that, 5% of the work, as far as patient's effort, side effects, toxicities, impact, and quality of life, all are concerns, 95% of that, in my view, is coming from radiation therapy and chemotherapy. And after that, little work from that perspective by the patient has to be done by atezolizumab, as far as getting treatment with atezolizumab is concerned. So as Petros said, this is a highly well-tolerated treatment, which is immunotherapy. And if you look at the potential of this drug to control the recurrence of the disease and allow our patients to maintain their bladder—it’s tremendous. So I think the expected returns are very high, and how much effort patients will have to put on the trials are not as high as you would expect if you are thinking about a trial. Dr. Pal: That was an excellent discussion of toxicities associated with this particular regimen, Neeraj. Petros, before we move on any closing thoughts? Dr. Grivas: No, I agree completely with Neeraj. I think these are important points. I just wanted to add a couple of key take-home message for the patients. Number 1, this trial is available for patients who either are or are not candidates for radical cystectomy, which is the removal of the bladder and again, it has to be a discussion with the providers whether they're good candidates for the attempt for bladder preservation. Half of the patients get the standard of care, which is chemotherapy and radiation at the same time, and the other half get chemotherapy and radiation, plus this immunotherapy called atezolizumab. And again, I think the last point to make is that chemotherapy and radiation have to happen at the cancer center, and some of the patients live far away, so I think it's important to discuss with the patients the pros and cons of the trial because it might entail some back and forth transportation for them if they have to get the radiation and the chemotherapy in the cancer center that is offering the trial. But overall, as Neeraj pointed out, we are very enthusiastic, and I'm personally enthusiastic about the study. Dr. Pal: That's great Petros, appreciate that. Now, in the final portion of our program, we're going to shift gears and talk about the type of cancer that I actually focus on personally in the clinic, and that is kidney cancer. And we have our resident expert in kidney cancer on the Cancer.Net panel, Dr. Tian Zhang from Duke here to discuss the PROSPER study, a very important national effort. [A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)] Tian, can you tell us about PROSPER? Dr. Zhang: PROSPER is a phase III trial that's open currently for patients who have locally advanced kidney cancer, and we know that in this population of patients who have locally advanced kidney cancer who undergo their surgery, there's still a high rate of recurrence up to about 50% with many dying, unfortunately, from disease recurrence. And so the question that PROSPER aims to answer is can we prevent disease from recurring, and thereby, can we allow patients to live longer from giving up-front systemic therapy in addition to their surgery? And so in kidney cancer, we know that patients will benefit from immune checkpoint inhibitors, and the big question of the study is that with the primary kidney cancer in place, what is the effect of this immunotherapy called nivolumab before and after surgery compared to surgery alone, and how should we use these immunotherapy agents in the perioperative setting to improve overall survival? Dr. Pal: That's very interesting. Of course, in kidney cancer, just as we discussed with prostate cancer, you've got patients who have the disease confined to the kidney. You have patients where the disease has spread. What particular patient population does this study focus on? Dr. Zhang: This study is enrolling patients with locally advanced disease, so either clinical stage II or higher. So that's patients who have primary tumors of greater than seven centimeters, or if they have positive lymph nodes on their scan, so clinical detection of lymph node-positive cancer. Or the study, actually, also allows cancer that has spread to no more than three, so one, two, or three, other sites, which can also be definitively treated at the time of the primary surgery. Patients who have disease spread to the lung, adrenal gland, lymph nodes, pancreas, or soft tissue are allowed. Patients who have spread to the liver or bone are not allowed. And the study is currently ongoing, Monty. It is randomizing up to 805 patients total. As of late January 2020, they're currently at about 390 patients already enrolled. So there's plenty more, about 400 more patients to go on the study. And it is an open and enrolling study. Dr. Pal: That's really interesting. Now, Petros gave us some insights as to the rationale for using immunotherapy in cancer. Is it the same rationale for using this treatment strategy in kidney cancer? Dr. Zhang: Sure. So our standard of care in this setting, as you know, for locally advanced disease is truly just nephrectomy alone to remove the kidney, usually without treatment afterward. And there are multiple adjuvant studies using immunotherapies in this post-operative setting, however, those are all pending. And we're hoping that immunotherapy used earlier in the disease course will allow us to see a benefit overall. Now, nivolumab, the immunotherapy that's studied in the PROSPER trial, is approved for metastatic kidney cancer. And therefore, we know nivolumab is effective at extending overall survival for these patients. And so the question is if we can use this active immunotherapy agent earlier in the disease course if we can to try to prevent disease recurrence. Dr. Pal: That makes a lot of sense. Now, what is this particular study attempting to demonstrate? What are we trying to prove here with this trial? Dr. Zhang: Right. So the primary outcome of PROSPER is the time to disease recurrence or spread to other sites, what we call recurrence free-survival. There are secondary outcomes. So trying to get patients to live longer, overall survival, toxicity of giving nivolumab up front for these patients. As well as, specifically in patients who have clear cell kidney cancer, the time to disease recurrence for those patients, as well. So there are patients who are on the control cohort of surgery alone, and we'll be able to study that tissue in conjunction and compare those with patients who have received immunotherapy or nivolumab prior to their surgeries. So they have a number of biomarkers planned for the tissue that's being collected from the study. Dr. Pal: Very interesting. Well, I can't wait to see the results, ultimately, of this trial. But in the meantime, Petros had outline some of the risks associated with immunotherapy in the context of the study he discussed. Anything to add to that, in terms of the risks that might be entailed in this trial? Dr. Zhang: Right. So it is certainly a randomized trial, as Petros mentioned, so there are patients who are randomized to surgery alone versus patients who are randomized to the immunotherapy up front. So one dose of nivolumab followed by surgery and then maintenance treatment with nivolumab. And I fully agreed with the toxicity profile that Petros outlined very nicely. And when we get patients started on these immunotherapies treatments in clinic, I often talk about, we're activating your immune system, and therefore, toxicities can occur where the immune system is very active. So on the skin it can cause a rash, in the GI tract it can cause diarrhea or colitis, in a very small proportion of patients it can cause inflammation in the lungs or liver, and then, finally, it can affect their endocrine organs: the pituitary, thyroid, adrenal glands, and pancreas. And one more note about treatment with these immune checkpoint inhibitors of nivolumab, and other agents like nivolumab, is that these are really not for patients who have active autoimmune disease. We think that those patients who have active autoimmune disease requiring prednisone or other disease-modifying agents, those patients are probably going to have worsening of their baseline autoimmune disorder. So patients who do have that need to have a very close discussion with their providers before going on any of these trials. Dr. Pal: Well, that's an excellent overview of toxicity, and again, just as I mentioned earlier, I certainly leave it in the hands of the patient and their respective clinicians to go through a very thorough discussion of toxicity, but I think that was a fantastic primer on it, Tian. Thank you for that. Before we close, I wanted to go to Petros for any additional comments on this concept of the PROSPER study. Petros, any additional thoughts? Dr. Grivas: I think that Tian did a wonderful job summarizing all the key points. I think one of the key characteristics of this trial is, again, their rationale. The reasoning behind it, which as Tian mentioned, is we have the immunotherapy up front in the beginning of the treatment while the tumor is still present and the proteins, the antigens of the tumor, are still present, and that might be relevant in the recognition of those elements by the immune system when you give the immunotherapy. And then you have surgery, and then you have continuation of postoperative treatment, as Tian mentioned, and maybe that combination approach may be relevant. We have to see, of course, but I think it's a very, very compelling design that makes sense, at least scientifically speaking. The other point, I think, is as [inaudible] already mentioned, this very [inaudible] teamwork, team effort from multiple investigators across the country. And that speaks volumes of the very nice design, as well as the collaborative in spirit, which I think is important for that patient to know, that people do work together to come up with these clinical trials. We all hope that this trial will keep accruing well and will end up with accrual target in order to answer this important question which is, as Tian mentioned, whether immunotherapy before and after surgery prolongs life and improves the times of cancer remission, which is important and clinically relevant question. And of course, it's a key point to have discussions about sometimes uncommon but significant immune-related reaction and go through the different nuances carefully with the providers when a patient's considering clinical trial. But clinical trials, as you mentioned Monty, is the way to develop new therapies and are very important part of a discussion in the routine patient care. Dr. Pal: Excellent, Petros. Well, on behalf of Dr. Petros Grivas, Dr. Neeraj Agarwal, and Dr. Tian Zhang, I really want to thank you for joining our very first podcast from Cancer.Net. There's so many different clinical trials out there enrolling patients with genitourinary cancers, and we've only had time here to discuss 3 of them. If you have interest in participating in clinical trials, please do get in touch with your healthcare team. And of course, Cancer.Net serves as an excellent resource to communicate with experts in the field and learn more about respective genitourinary types of cancer. Thank you again for joining. ASCO: Thank you, Drs. Pal, Agarwal, Grivas, and Zhang. Visit www.cancer.net/clinicaltrials to learn more about participating in clinical trials. All treatments have side effects—please talk to your health care team about possible side effects to watch out for. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org.  Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds breakthrough research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at conquer.org/donate.

After a fierce struggle for naming rights, the last lanthanoid element to be discovered was eventually named after Paris, says Allan Blackman in ep 45 of Elemental.

After a fierce struggle for naming rights, the last lanthanoid element to be discovered was eventually named after Paris, says Allan Blackman in ep 45 of Elemental.

After a fierce struggle for naming rights, the last lanthanoid element to be discovered was eventually named after Paris, says Allan Blackman in ep 45 of Elemental.

Dr. Jonathan Strosberg, section chief of the Neuroendocrine Tumor Division of the Moffitt Cancer Center, discusses the recent FDA approval of Lutetium Lu 177 dotatate for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Lutetium podcast from Chemistry World - the magazine of the Royal Society of Chemistry.

Special BBC2 Edition The Show Notes:     Geo's explanation of this week's show Intro An erotic reading in the city Unsexy…unsexy…unsexy Finally…John's great story Circumcision inquiry Occasional Songs for the Periodic Table Thulium, Ytterbium, Lutetium, Halfnium, Tantalum, Tungsten, Rhenium, Osmium, Iridium, Platinum, Gold, Mercury, Thallium, Lead, Bismuth, Polonium, Astatine, Radon, Francium, Radium, Actinium, Thorium, Protactinium Louis Pierre Monchant’s Bastardes Indestructable - Herbert "The Cat" Noble Ask George - christians and global warming (from Jay Parlar) Religious Moron of the Week - Reverend Charles Eugene Flowers Another Geologic Podcast Giveaway - translate Tantalum and win Show Close ...................................... Mentioned in the show: the Skepdudes calendar via Skepchick And as always: George's blog, website, flickr, and myspace page. Have a comment on the show, a topic for Minoishe Interroberg, or a question for Ask George? Drop George a line at geo@geologicrecords.net or through his blog. First commenter to translate the lyrics to Tantalum wins a Skepdude calendar!

Seltene Erde Elemente sind eine Gruppe ähnlicher Elemente, zu denen das Lanthan und die 14 im Periodensystem folgenden Elemente Cer, Praeseodym, Neodym, Promethium, Samarium, Europium, Gadolinium, Terbium, Dysprosium, Holmium, Erbium, Thulium, Ytterbium und Lutetium zugerechnet werden. Lanthancarbonat wird in der Humanmedizin in neuester Zeit als Phosphatbinder bei Dialysepatienten eingesetzt. Es handelt sich dabei um einen nicht aluminiumhaltigen Phosphatbinder, der ein ebenso großes Phosphatbindungspotenzial aufzuweisen scheint wie Aluminiumhydroxid. In der vorliegenden Arbeit wurde der phosphorsenkende Effekt von Lanthancarbonat im Vergleich mit Aluminiumhydroxid und einer Nierendiät bei Katzen untersucht. Die Untersuchung wurde als Fütterungsversuch über einen Zeitraum von zehn Monaten an zwölf Europäisch Kurzhaarkatzen durchgeführt, die randomisiert in zwei bzw. vier Gruppen aufgeteilt wurden. Während dieses Versuchszeitraumes wurde dem Futter in insgesamt sieben verschiedenen Fütterungsperioden entweder Lanthancarbonat (34 mg/kg KM/d) oder Aluminiumhydroxid (90 mg/kg KM/d) in einer oder mehrmaliger Dosierung als Phosphatbinder zugesetzt. Die Effekte dieser Phosphatbinder wurden dabei bei bedarfsgerechter Phosphorversorgung (Alleinfutter) bzw. bei phosphorreduzierter Fütterung (Nierendiätfutter) untersucht. Als Proben wurden am Ende jeder Fütterungsperiode Blut, 24h-Urin und Kot genommen. In diesen Proben wurde jeweils der Phosphorgehalt bestimmt. Anhand der jeweiligen Gesamturin- bzw. -kotmenge wurde zusätzlich die Phosphorexkretion pro kg Körpermasse und Tag ermittelt. Die Ergebnisse dieser Studie zeigen, dass sowohl Lanthancarbonat als auch Aluminiumhydroxid bei klinisch gesunden Katzen im gewählten Untersuchungszeitraum (14 Tage) und einer Dosierung von 34 bzw. 90 mg/kg Körpermasse/1 x tgl. kaum Effekte auf den Phosphorstoffwechsel erzielten. Die Verfütterung eines Nierendiätetikums konnte im gleichen Untersuchungszeitraum und im gleichen Versuchsaufbau die Phosphorkonzentrationen des Serums, des Urins und des Kotes senken und die renale und fäkale Gesamtexkretion an Phosphor vermindern. Um eine endgültige Bewertung der Wirkung von Lanthancarbonat im Vergleich mit Aluminiumhydroxid auf den Phosphorstoffwechsel der Katze vorzunehmen, müssten allerdings weitere Untersuchungen mit höheren Dosierungen, längeren Versuchszeiträumen und über den Tag verteilten Dosierungen durchgeführt werden.

Seltene Erden, eine Gruppe von 17 Übergangsmetallen aus der dritten Nebengruppe des Periodensystems, zu denen unter anderem Lanthan sowie die 14 Lanthanoide von Cer bis Lutetium zählen, werden in China schon seit mehreren Jahrzehnten erfolgreich in der Tierernährung eingesetzt. Sie werden dort zur Ertrags- und Leistungssteigerung in der Tierproduktion dem Tierfutter beigemengt. So finden sich zahlreiche chinesische Veröffentlichungen, in denen beim Einsatz von Seltenen Erden deutliche Leistungssteigerungen bei einer Vielzahl von unterschiedlichen Tierarten beobachtet werden konnten. In bisherigen Versuchen an unserem Lehrstuhl für Tierernährung und Diätetik der Tierärztlichen Fakultät der Ludwig-Maximilians-Universität München konnten auch unter westlichen Haltungs- und Fütterungsbedingungen leistungssteigernde Effekte durch Gemische Seltener Erden bei Schweinen, Broilern und Ratten nachgewiesen werden. In der vorliegenden Arbeit wurden erstmals sowohl verschiedene Gemische als auch ein einzelnes Seltenes-Erden-Element in jeweils unterschiedlichen Dosierungen und chemischen Verbindungen in mehreren Fütterungsversuchen mit Ratten und Broilern auf ihre Auswirkungen auf Leistungsparameter sowie auf den Intermediärstoffwechsel untersucht. In zwei Fütterungsversuchen mit insgesamt 560 Ratten, die in 56 Versuchsgruppen (n=10) eingeteilt waren, konnten keine positiven Auswirkungen durch eine Supplementierung des Futters mit Seltenen Erden auf Mastleistungsparameter beobachtet werden. Ein Einfluss der Seltenen Erden auf den Intermediärstoffwechsel der Ratten konnte anhand unserer Untersuchungen unter den von uns gewählten Fütterungs- und Haltungsbedingungen nicht bestätigt werden. Des Weiteren wurden zwei Fütterungsversuche mit jeweils 76 Broilern durchgeführt. Hierbei konnte in einem der Versuche durch den Einsatz eines Gemisches an Seltenen Erden eine signifikante Erhöhung der Gewichtszunahmen von bis zu 13 % beobachtet werden. Ebenso kam es zu einer signifikanten Verbesserung der Futterverwertung um bis zu 3,9 %.