Podcasts about mcspc

In the first episode of this three-part series focused on the presentations and findings from the ESMO Congress 2024, our hosts focus on mCSPC prostate cancer treatment advancements, including lutetium PSMA, darolutamide and much more. The View on GU with Lalani & Wallis integrates key clinical data from major conferences and high impact publications, sharing meaningful take home messages for practising clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: theviewongu.ca This podcast has been made possible through unrestricted financial support by Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Ipsen, J&J Innovative Medicine, Merck, Novartis, Pfizer, TerSera.

This podcast “Apalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC): A Case-Based Discussion” was originally presented as an AUA newsworthy webinar and contains data regarding the clinical efficacy and safety of apalutamide. It is presented on behalf of Janssen and is not certified for CME; speakers were compensated. For full details, see the video webinar here. TITAN, a Phase 3 double-blind study, randomized patients with metastatic castration-sensitive prostate cancer (mCSPC) to apalutamide (Apa; 240 mg oral once daily) + androgen deprivation therapy (ADT; n=525) or placebo + ADT (n=527).1,2 All patients received a concomitant gonadotropin-releasing hormone analog or had prior bilateral orchiectomy.3 Patients who received prior treatment for localized disease or received but did not progress on docetaxel were permitted. Dual primary endpoints were radiographic progression-free survival and overall survival (OS).1,2 At primary analysis (median follow-up: 22.7 months), Apa + ADT reduced the risk of radiographic progression or death by 52% vs placebo + ADT (HR: 0.48; 95% CI: 0.39–0.60). Apa + ADT also reduced the risk of death by 33% vs placebo + ADT (HR: 0.67; 95% CI: 0.51–0.89).1 At primary analysis cutoff, TITAN was unblinded and 39.5% of patients who received placebo + ADT crossed over to receive Apa + ADT; these patients were analyzed as part of the placebo + ADT population in the intent-to-treat analyses. The IPCW log-rank test was performed to account for crossover and showed a 48% reduction in the risk of death for Apa + ADT vs placebo + ADT (HR: 0.52; 95% CI: 0.42–0.64). At final analysis (median follow-up: 44.0 months), Apa + ADT reduced the risk of death by 35% vs placebo + ADT (median OS: NE vs 52.2 months; HR: 0.65; 95% CI: 0.53–0.79). In a prespecified subgroup analysis, Apa + ADT improved OS vs placebo + ADT, regardless of disease volume. In patients with high-volume disease, Apa + ADT reduced the risk of death by 30% vs placebo + ADT (HR: 0.70; 95% CI: 0.56–0.88); for low-volume disease, Apa + ADT reduced the risk of death by 48% vs placebo + ADT (HR: 0.52; 95% CI: 0.35–0.79).2 The following post hoc analyses data are not included in the full ERLEADA® (apalutamide) Prescribing Information. Post hoc exploratory analyses investigated PSA kinetics.4,5 After 3 months of Apa treatment, median OS was not reached in patients with a PSA response. In patients without a PSA response, median OS was 37.7 months.5 Most Apa + ADT-treated patients had undetectable PSA at 3 months. By 12 months, 64% of Apa-treated patients had undetectable PSA vs 23% of patients treated with placebo + ADT.5 Please see the full Prescribing Information for ERLEADA® (apalutamide) at www.erleadahcp.com. Chi KN, et al. N Engl J Med. 2019;381:13–24. Chi KN, et al. J Clin Oncol. 2021;39:2294–2303. ERLEADA® (apalutamide) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. Chowdhury S, et al. Ann Oncol. 2023;34:477–485. Chi KN, et al. Presented at AUA; September 10–13, 2021; Las Vegas, Nevada.

Drs. Neeraj Agarwal and Todd Morgan discuss CONTACT-02, KEYNOTE-564, CheckMate-67T, and other notable studies featured at the 2024 ASCO Genitourinary Cancers Symposium, as well as additional key abstracts in prostate, kidney, and bladder cancers that will significantly influence clinical practice. TRANSCRIPT Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program and professor of medicine at the Huntsman Cancer Institute at the University of Utah, and editor-in-chief of ASCO Daily News. Today, we'll be discussing practice-changing abstracts and other key advances in GU oncology featured at the 2024 ASCO Genitourinary Cancers Symposium. Joining me for this discussion is Dr. Todd Morgan, the chair of this year's ASCO GU. Dr. Morgan is a urologic surgeon, chief of urologic oncology at Michigan Medicine, and a professor of urology at the University of Michigan. Our full disclosures are available in the transcript of this episode, and the disclosures of all guests on the podcast can be found at asco.org/DNpod. Todd, thank you for joining us today. Dr. Todd Morgan: Thanks so much, Neeraj. It's an honor to be here and I'm just thrilled to be able to do this with you. Dr. Neeraj Agarwal: Thank you. So, the GU meeting showcased significant advancements across the spectrum of GU malignancies. Can you tell us about the hot topics that captured the headlines this year? What did you find exciting this year at the ASCO GU Symposium? Dr. Todd Morgan: The theme of this year's meeting was "20 Years of Advancing Science and Transforming Patient Care," and this reflected ASCO GU's incredible milestone in GU cancer research over the last 2 decades. We were thrilled to welcome over 5,200 attendees from over 70 countries, and, believe it or not, there were more than 875 abstract submissions, compared to more than 300 in the meeting's first year. Most of the participants were present in person and that was fantastic. It enabled great networking opportunities and opportunities for experts, trainees, and mentees to exchange knowledge and ideas. Without a doubt, ASCO GU remains the annual meeting in our field, and it's amazing to hear the breadth and depth of the state-of-the-art science that's presented at this meeting, and so much of it impacts patient care the second that you return home. Additionally, the meeting's focus on diversity and interactivity, networking, multidisciplinary collaboration, and evidence-based care were absolutely phenomenal from my standpoint. We had a lunch session for women's networking that was a huge success—the first time we've done that. The keynote lecture by Dr. Cheryl Lee that talked about ensuring adequate representation in clinical trials was a huge hit, and we had tremendous positive feedback from that lecture. There were also multiple featured sessions on different diagnostic and therapeutic challenges in localized, recurrent, and advanced GU cancers. And, Neeraj, my personal favorite during the symposium is always the Trainee and Early-Career Networking Luncheon on the first day and then the additional networking luncheons on the 2 following days. I had great conversations with a ton of trainees and junior faculty, and I feel so fortunate for the opportunity to get to know the future superstars in our field. So I'd like to kick it back to you for a second because the first day started with a focus on prostate cancer and some of the key clinical trials. A great example is Abstract 17, which was the second oral presentation delivered, and really congratulations to you, Neeraj, on sharing the exciting data from the CONTACT-02 trial which we were eagerly awaiting. And I'd love to get your thoughts on the data that you presented. Could you tell us more about that trial? Dr. Neeraj Agarwal: Yes, Todd, I agree with you. It was such an exciting conference overall, and thank you for your leadership of this conference. So let's talk about the CONTACT-02 trial. It was a phase 3 randomized trial assessing the combination of cabozantinib and atezolizumab versus a second NHT in patients with metastatic castration-resistant prostate cancer after progression on one NHT. This patient population had to have extrapelvic soft tissue metastases, which could be liver metastases, lung metastases, or lymph nodal metastases, and about up to a quarter of patients had liver metastases. And overall, this was a high-risk patient population which was randomized to, as I said, cabozantinib plus atezolizumab versus a second line NHT. And these patients had received a prior NHT, mostly in the mCRPC setting.  The co- or dual primary endpoints were overall survival and progression-free survival (PFS). And a unique thing was that PFS was assessed only by RECIST 1.1 because, as per our discussions with regulatory authorities, the trial was focused on soft tissue metastases because of questions in the past that cabozantinib can affect bone lesions in an artifactual fashion, possibly concerns. That's why the PCWG 3 criteria were not used as the primary endpoint, but, of course, indeed used as another key endpoint, so we have information on both. Anyway, coming back to the endpoint 1:1 randomization. The randomization was stratified by presence or absence of liver metastases, prior docetaxel chemotherapy, and the setting in which NHT was given (mCSPC or CRPC). The PFS or primary endpoint was significantly improved with a 35% reduction in risk of progression or death with the cabozantinib-atezolizumab combination versus second NHT. And there was a trend for overall survival, with a hazard ratio of 0.79 favoring the cabozantinib-atezolizumab combination. Interestingly, all subgroups benefitted, regardless of age, region, site of metastases, but we decided to choose three clinical subgroups of interest such as patients with liver metastases, patients with prior docetaxel chemotherapy in the castration-sensitive setting, and bone metastases, and all these subgroups seemed to be benefitting with the strongest signal in the liver metastasis subgroup, with a 57% reduction in risk of progression or death, which I would argue we have never seen with any combination or any regimen in the metastatic prostate cancer setting yet, barring some targeted therapies in very selected patients. But overall, across the non-biomarker-selected patients, we have never seen this kind of signal. Toxicity — no discussion is complete without discussing toxicity, so I would like to highlight that. Safety signal — there were no new safety signals. The most common grade 3-4 adverse events were hypertension in 7%, anemia in 6%, which were similar in both arms, and, of course, diarrhea and fatigue in 4% each. And if we look at the secondary endpoints, such as time to chemotherapy and time to symptomatic skeletal events, they tended to favor the cabozantinib-atezolizumab. To sum it up, cabozantinib-atezolizumab showed a significant PFS benefit, with a 35% reduction in risk of progression or death, with a trend for overall survival in this patient population with an unmet need. So thank you so much, Todd, for allowing me to summarize the results of this trial. Dr. Todd Morgan: Yeah, wow. That's so impressive, and not surprising that you could so fluidly go right through all that data. Amazing. We heard some discussion of the NHT control arm in this trial. Could you discuss that for a bit? Because it obviously has implications on the similar control arm of other ongoing trials in this setting. Dr. Neeraj Agarwal: Absolutely. Pretty much all trials, every trial which has recently been reported or started in metastatic castrate-resistant prostate cancer have a similar second NHT arm. Whether there were multiple immunotherapy trials which we have just reported, or new trials which are starting or just started enrolling patients. And the reason for that is no randomized trial has ever shown superiority of docetaxel chemotherapy over a second NHT after failure of prior NHT in the mCRPC setting. That's number one. If you look at NHT as a control, it is accepted by health authorities globally with multiple recent trials which are just starting also having NHDR and it would not have been possible without the approval of global regulatory authorities across the world.  Then, if you look at the recently reported trial in the mCRPC setting with prior treatment with an NHT, there is an indication that chemotherapy may not be superior to NHT. For example, in the KEYNOTE-641 trial in patients with mCRPC with prior NHT, randomizing patients to enzalutamide plus pembrolizumab versus enzalutamide, the median PFS with enzalutamide was 9 months. This is very similar with docetaxel in patients randomized to docetaxel plus pembrolizumab versus docetaxel; the median PFS with docetaxel is 8 months or 8.3 months. And lastly, if you really want to have a comparison of chemotherapy with NHT which has been done after progression on NHT and docetaxel chemotherapy, so later line of mCRPC setting, that is the CARD trial, as you can imagine, cabazitaxel versus NHT, especially in patients with visceral metastasis, which was the point of discussion. For example, people may not feel comfortable randomizing patients to NHT compared to taxane. The hazard ratio for PFS supporting cabazitaxel was 0.79, so almost a 0.80 PFS hazard ratio, which we have never seen turning out to be a clinically significant benefit. So, if you combine all these data together, I think it was absolutely acceptable to us as investigators to have a second NHT as the control arm. And of course, when we are consenting the patient, we have to keep alternatives in mind, and we do talk about those alternatives with the patients. And if alternatives seem more applicable, we should not be talking to patients about those clinical trials or a given clinical trial in the clinic. I'm glad you brought this up, Todd, because this control NHT arm is not an issue with this trial, but all trials which should be presented in GU ASCO in the future meetings in the coming years. So, thank you. Dr. Todd Morgan: Yeah, thank you. It's such an important topic and controversy at some level, but it's a difficult problem to think about and obviously highly relevant to all the trials that we're looking at. Congrats again on that trial, that's tremendous. There was another important randomized phase 3 trial and it covers radiotherapy in patients with high-risk localized prostate cancer. Can you give us your insights on that one? Dr. Neeraj Agarwal: Yeah, Todd, I think you are referring to LBA259, titled "Long-term Results of Dose Escalation of Radiation Therapy from 70 Gy to 80 Gy Combined with Long-term Androgen Deprivation Therapy in High-risk Prostate Cancer: The GETUG-AFU 18 Randomized Trial." As you mentioned, in this randomized phase 3 trial, Dr. Christophe Hennequin and colleagues randomized patients with high-risk prostate cancer, which means they had to have either clinical stage T3 or T4 disease, or PSA ≥20 nanograms per milliliter, or a Gleason score between 8 and 10. These patients were randomized to receive ADT for 3 years combined with either dose-escalated intensity-modulated radiotherapy. So, I'd like to highlight, this was in the context of IMRT in the dose of 80 Gy or a conventional dose of 70 Gy. Now, you can argue that more people are using more than 70 Gy nowadays, but across the world, the conventional dose is still considered 70 Gy. So, 80 Gy versus 70 Gy were tested. Patients also had to have negative lymph node status on CT scans and MRI. The primary endpoint was biochemical progression-free survival or clinical progression-free survival at 5 years following the ASTRO Phoenix definition. Secondary endpoints – and these are quite important secondary endpoints – include overall survival, acute and late toxicity, and quality of life. The best part is that this trial met its primary endpoint with a 44% reduction in risk of biochemical or clinical progression or death in the dose-escalation radiotherapy arm compared with the conventional radiotherapy arm. Interestingly, a significant 52% improvement in prostate cancer-specific survival and a 39% improvement in overall survival was observed in the dose-escalated arm. So, 80 Gy continued to be superior to 70 Gy IMRT across the primary and secondary endpoints. Now, the best part is, regarding the toxicity profile, there was no significant difference between the 2 arms, with 78% of patients in the higher dose arm and 76% of patients in the conventional arm experiencing grade 2 or more toxicities. Dr. Todd Morgan: Great summary and really important, great news for our patients. Of course, it's a slightly different setting as it's high-risk localized prostate cancer. I checked in with our radiation oncologists at the University of Michigan after that [presentation] because I couldn't remember exactly where we are in terms of dose on these patients. And they were like, “Yeah, we've been doing 80 to 90 Gy for several years,” so it's great having this data to support that. And I think, as you said, the field at many centers has already moved that way. And again, the key takeaway from this abstract would be that IMRT, in combination with long-term androgen deprivation therapy, is effective and safe and increases not only the biochemical or clinical PFS rate, but also the cancer-specific survival and overall survival, again, in high-risk localized prostate cancer patients. And it does not appear to increase long-term toxicity. So really important. It'd be great to switch gears and discuss kidney cancer, if that's okay, and talk about some key abstracts in that field. What do you think? Dr. Neeraj Agarwal: There were so many exciting data in all cancers, which is amazing. So, Todd, could tell us about the LBA359, which I thought was one of the most impactful abstract presentations in the ASCO GU this year. It was titled, “Overall Survival Results from the Phase 3 KEYNOTE-564 Study of Adjuvant Pembrolizumab Versus Placebo for Treatment of Clear Cell Renal Cell Carcinoma (ccRCC)."   Dr. Todd Morgan: Yeah, this was a really big moment in our field, complete with a mid-presentation round of applause that was well deserved. And so this abstract was presented by Dr. Toni Choueiri from Dana-Farber Cancer Institute, and it included patients with clear cell renal cell carcinoma at intermediate high or high risk of recurrence, meaning that they had positive nodal disease or negative nodal disease with PT 2 and grade 4, or sarcomatoid features, or stage PT 3 or 4. These patients underwent nephrectomy with or without metastasectomy less than 12 weeks before randomization and had not received prior systemic therapy for clear cell RCC. Patients were randomized to receive either pembrolizumab 200 milligrams or placebo IV every three weeks for at least 17 cycles, or until disease recurrence, intolerable toxicity, or withdrawal of consent. Disease-free survival by investigator assessment was the primary endpoint, and overall survival was a key secondary endpoint. In this abstract, Dr. Choueiri and colleagues report results of the third prespecified interim analysis with a median follow-up of around 57 months in 496 patients receiving pembrolizumab and 498 patients receiving placebo. So, just as a reminder to the audience here, the first interim analysis reported at a median follow-up of 24 months and showed a significant reduction of 32% in the risk to recurrence or death in patients in the pembrolizumab arm. Then subsequently in November of 2021, the FDA approved pembrolizumab for the adjuvant treatment of patients with RCC who are at intermediate high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. At that time, though, overall survival data were still immature. So, at the third prespecified interim analysis with a median follow-up of around 57 months, pembrolizumab showed, for the first time in an adjuvant RCC setting, improved overall survival with a 38% reduction in the risk of death. The estimated OS rate at 48 months was 91.2% with pembrolizumab and 86% with placebo. Furthermore, the OS benefit was observed across key subgroups, including patients with non-metastatic disease, patients with metastatic but no evidence of disease, patients with PDL-1 combined positive score less than or greater than or equal to one, and patients with presence or absence of sarcomatoid features. In each of these subgroups, the forest plot looks really impressive. And the DFS benefit was similar to previously reported interim analyses with a hazard ratio of 0.72. Also, no new safety signals with pembrolizumab were observed so just tremendous data. Dr. Neeraj Agarwal: Thank you, Todd, for such a great summary of these very important results. So the key message from this abstract, as you said, is that after a median follow-up of around 57 months, which is a long follow-up, adjuvant pembrolizumab demonstrates a statistically significant and clinically meaningful improvement in overall survival versus placebo in patients with RCC at high risk of disease recurrence after surgery. And this is, by the way, the first phase 3 study to show improved overall survival with any adjuvant therapy in RCC. Basically, this means we should continue to use adjuvant pembrolizumab or at least bring it up in our discussion with our patients who are in a similar situation with high-risk RCC after surgery. So this is great news overall. Todd, there was another kidney cancer abstract, LBA360, which compared, interestingly, subcutaneous nivolumab with intravenous nivolumab in patients with metastatic renal cell carcinoma. Could you please give us your insight about this abstract?   Dr. Todd Morgan: Sure. Really interesting study. Really interesting data that were presented. So as you mentioned, CheckMate 67T was a multicenter, randomized, open-label phase three study led by Dr. Saby George and colleagues that evaluated pharmacokinetics and objective response rate non-inferiority of subcutaneous nivolumab versus IV nivolumab in patients with locally advanced or metastatic clear cell RCC. So patients with measurable disease that progressed during or after 1 to 2 prior systemic regimens and who did not receive a prior immuno-oncology treatment were randomized 1-1 to receive either subcutaneous nivolumab 1200 milligrams every 4 weeks or IV nivolumab 3 milligrams per kilogram every two weeks until disease progression, unacceptable toxicity, withdrawal of consent, completion of two years of treatment, or death. The coprimary pharmacokinetics endpoints for non-inferiority testing were time-average serum concentration over the first 28 days and minimum serum concentration at steady state determined by a population pharmacokinetics analysis. A key secondary endpoint was objective response rate by independent review. So in 248 patients receiving subcutaneous nivolumab and 247 patients receiving IV nivolumab, non-inferiority for the coprimary pharmacokinetics and key-powered secondary objective response rate endpoints were met. The relative risk ratio for objective response rate was 1.33. The median PFS by independent review was 7.23 months in the subcutaneous group and 5.65 months in the IV group. Treatment-related serious adverse events occurred in 6.5% of patients in each group, and study drug toxicity led to 3 deaths in the subcutaneous group and 1 death in the IV group. These results could support using subcutaneous nivolumab as a new option to improve healthcare efficiency, especially since the average injection time with subcutaneous nivolumab was less than 5 minutes. I think we all know what issues are going on in infusion beds across the country, including, I'm sure, your center and mine. Dr. Neeraj Agarwal: Yes, absolutely. I think this is great news for our patients, Todd. Thank you. This shows that we are not only improving therapeutic options and diagnostic tools, but maybe we're also on the right track towards more practical administration routes, assisting in addressing the treatment burden and improving the efficiencies of healthcare systems. We love to have this option available for our patients, especially those who are pressed for time. So, Todd, would you like to move on to bladder cancer now?  Dr. Todd Morgan: Yeah, Neeraj, that'll be fantastic. I'm sure listeners would love to hear more about LBA530. Could you tell us more about this one, Neeraj? Dr. Neeraj Agarwal: Of course. I think this abstract is titled "Enfortumab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Previously Untreated, Locally Advanced or Metastatic Urothelial Carcinoma: Subgroup Analysis Results from EV-302," which was a global phase three study and was presented by Dr. Michiel Van Der Heijden. As our audience may recall, the EV-302 trial was presented at the ESMO 2023 meeting by Dr Tom Powles and the results were very exciting where, for the first time, a combination outperformed traditional gemcitabine-cisplatin chemotherapy. In this trial, patients with previously untreated with metastatic advanced urothelial carcinoma were randomized 1-1 to receive a 3-week cycle of a combination of enfortumab vedotin, which, as we know, is an antibody-drug conjugate targeting nectin-4 expressed on the cancer cells and pembrolizumab, which is a PD-1 inhibitor, versus gemcitabine and cisplatin or carboplatin, which were, until recently, the standard of care in this setting, and continue to be so in many countries in the world. The combination of enfortumab and pembrolizumab reduced the risk of progression or death by 55% and reduced the risk of death by 53% in the overall population. So consistent decrease in the hazard ratios for PFS and OS, and consistent improvement in overall survival and PFS in that previously reported presentation in the ESMO 2023. Now, based on these results, this combination was recently approved by the FDA in December 2023 for patients with advanced or metastatic urothelial carcinoma. So now the abstract, which was presented at the ASCO GU 2024 meeting, reported the results of a prespecified subgroup analysis. Select secondary endpoints included objective responses, duration of response, and safety. In 442 patients receiving the combination of enfortumab vedotin plus pembrolizumab, and a similar number of patients receiving chemotherapy both PFS and OS were higher for the combination of EV and pembro among prespecified subgroups such as race, platinum eligibility, PDL-1 expression, metastatic site, involvement of the liver or kidney function. Interestingly, the combination of EV and pembro reduced the risk of death by 53% in patients with visceral metastasis and 54% in patients with node-only metastasis. The improvement in PFS seems to be consistent regardless of the site of metastasis. In patients with moderate to severe renal function, the risk of death was reduced by 50% in patients receiving combination therapy. This is one of the best findings of these results because we always face challenges in treating patients with suboptimal kidney function and we cannot use cisplatin. Overall, EV plus pembro continues to show superior efficacy compared to platinum-based regimens across subgroups across the subgroups across the site of metastasis regardless of kidney function and so on. Dr. Todd Morgan: Yeah, just amazing data. I love hearing you spell it out like that. So, thank you again for the opportunity for me to sit here with you and listen to you talk about these data. It's impressive that we have been able to expand our therapeutic arsenal for urothelial carcinoma with an immune-targeting regimen that can spare our patients potential side effects of chemotherapy. What would your final takeaway on this abstract be? Dr. Neeraj Agarwal: I agree with you, Todd. I would add that the OS benefit was consistently observed across these select prespecified subgroups, including those historically associated with poor prognosis. The results of this new analysis support the finding of primary results, which indicate that EV plus pembro is a potentially new standard of care for patients with newly diagnosed, locally advanced, or metastatic urothelial carcinoma. Before we wrap up the bladder cancer session and the podcast, Todd, could you please give us insights about LBA531? Dr. Todd Morgan: Yeah, absolutely. I loved getting to hear this abstract presented. This one is titled “Ambassador,” known as the AMBASSADOR trial aligns A031501, a phase 3 randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma versus observation, that was presented by Dr. Andrea Apolo. It's an open-label, randomized, phase 3 trial that included patients with muscle-invasive urothelial carcinoma of the bladder, upper tract, or urethra. Eligible patients had pathologic tumor stage T2 or greater and/or positive pathologic nodal disease or positive margins at surgery following neoadjuvant chemotherapy, or patients with pathologic tumor stage T3 or greater and/or positive pathologic nodal disease or positive margins at surgery without prior neoadjuvant chemotherapy, and who were cisplatin ineligible or declined adjuvant cisplatin-based therapy. These patients were randomized one to one to either receive pembrolizumab 200 milligrams every 3 weeks for 1 year or observation. The dual primary endpoints were disease-free survival and overall survival. Secondary objectives included evaluation of DFS and OS in PDL-1 positive and negative patients and assessing safety. A total of 354 patients were enrolled to receive pembrolizumab and 348 to the observation arm, and 21% of the patients in the observation arm received a subsequent immune checkpoint inhibitor. At a median follow-up of 22.3 months for DFS, the median disease-free survival in the pembrolizumab arm was 29 months, while it was only 14 months in the observation arm with a hazard ratio of 0.69. At the interim analysis, OS data showed only a trend toward better outcomes in the pembrolizumab arm, which did not, however, reach statistical significance, with a median of 50.9 months in the pembrolizumab arm and 55.8 months in the observation arm with a hazard ratio of 0.98. These results could nevertheless have been impacted by the subsequent treatment of patients in the observation arm with an immune checkpoint inhibitor, especially after the FDA approval of nivolumab in 2021 for patients with muscle-invasive urothelial carcinoma, based on results of the CheckMate 274 trial. In terms of the safety profile, grade three or more adverse events occurred in 48.4% of patients in the pembrolizumab arm and 31.8% of patients in the observation arm. Dr. Neeraj Agarwal: That's great, Todd. This is such a great summary of this trial, and this is exciting news for our patients with muscle-invasive urothelial carcinoma. I'm hoping that pembrolizumab will be another option for our patients when we are discussing adjuvant immunotherapy in the clinic, moving forward very soon. With that, we have covered several abstracts addressing prostate, bladder, and kidney cancer, significantly influencing our medical practices, at least at the current moment or in the near future. Todd, thank you for sharing your insights today. These are undoubtedly exciting updates for all members of the GU oncology community, and we are grateful for your valuable contribution to the discussion. Many thanks. Dr. Todd Morgan: Thanks, for having me, Neeraj; this was really fun. I'm just really proud and excited to still be part of this field, to be part of the GU oncology field, and it continues to be exciting for all the folks who are coming up. Dr. Neeraj Agarwal: Indeed. And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you very much.   Disclaimer: The purpose of this podcast is to educate and 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.   Find out more about today's speakers:   Dr. Neeraj Agarwal @neerajaiims   Dr. Todd Morgan @wandering_gu   Follow ASCO on social media:   @ASCO on Twitter     ASCO on Facebook     ASCO on LinkedIn       Disclosures:    Dr. Neeraj Agarwal:    Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences    Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas   Dr. Todd Morgan: Consulting or Advisory Role: Myriad Genetics, MDxHealth, TerumoBCT Research Funding (Institution): Prostate Cancer Foundation, National Institutes of Health, Department of Defence, GenomeDX Biosciences, Myriad Genetics, MDxHealth  

Listen to this live podcast from the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting With Stephen Freedland, MD!

Prostate Cancer Highlights from ASCO GU, ASCO and EAUN 2022 COR2ED Medical Education: In this podcast Dr Jason Alcorn and Jennifer Sutton discuss the oncology nursing highlights from ASCO GU, ASCO and EAUN 2022. The experts discuss: Treatment intensification with triplet therapy for mCSPC patients with practice changing data from the ARASENS trial and updated overall survival from the ENZAMET trial Subgroup analysis of prior and concomitant treatment from the VISION trial A number of practice development studies using technology to aid knowledge sharing and to improve the quality of patients’ care

COR2ED Medical Education: Dr. Tanya Dorff, a Medical Oncologist from the City of Hope Comprehensive Cancer Center and Dr. Neal Shore, Uro-Oncologist and Chief Medical Officer for Genesis Care and Urology and Surgical Oncology in the United States discuss ‘Timing of ARSI and taxanes for mCSPC' in this GU CONNECT podcast. In this podcast, the experts reflect on how the treatment landscape for mCSPC has evolved over the past 7 years resulting in treatment intensification with ADT plus docetaxel following the CHAARTED and STAMPEDE studies and then more recently the use of ADT and androgen receptor inhibitors including abiraterone (LATITUDE, STAMPEDE), apalutamide (TITAN), and enzalutamide (ARCHES, ENZAMET).  This has further evolved with the recent reporting of the PEACE 1 and ARASENS trials which demonstrated a survival benefit with triplet therapy with abiraterone and darolutamide respectively, being used in combination with ADT and docetaxel. The experts discuss the importance of balancing benefit against risk for their mCSPC patients but state that the triplet therapies appear to be well tolerated in both the PEACE 1 and ARASENS trials. They provide their views, Neal as a urologist and Tanya as a medical oncologist, on the things to consider when making treatment decisions for these patients such as comorbidities, age, performance status, de novo versus recurrent disease, amongst others. They finish by concluding that treatment intensification should be implemented as standard of care for mCSPC patients to enable patients to have as many treatments with different mechanisms of action as early as possible in their treatment journey. 

Go online to PeerView.com/UDM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The therapeutic landscape for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly in recent years, and research endeavors continue to expand treatment options with significant implications for patients. In addition to the approval of multiple second-generation androgen deprivation therapies (ADTs), current clinical trials are investigating novel targeted therapies, immunotherapies, and combination approaches in different disease settings. Furthermore, when managing patients with mCSPC, clinicians must consider established, newly approved, and emerging therapies, as well as individual patient-, tumor-, and treatment-related factors. Given the wealth of new options, how do clinicians determine the best treatment course for each patient? Answers to this and other thought-provoking queries are provided in this educational activity based on a recent live symposium, as a panel of prostate cancer experts examine the latest clinical data for novel and emerging therapeutic approaches and discuss evidence-based strategies for individualizing treatment for each patient with mCSPC. Upon completion of this activity, participants should be better able to: Assess the rationale and clinical evidence for novel therapeutic approaches for patients with mCSPC, such as the addition of novel androgen axis inhibitors or docetaxel to ADT, Develop optimal, individualized treatment plans for patients with mCSPC that incorporate novel therapeutics as appropriate, taking into consideration individual patient-, disease-, and treatment-related factors, Apply evidence- and team-based strategies to proactively mitigate and manage treatment-related adverse events that may occur in patients with mCSPC who are receiving novel therapeutics as part of their care, Employ effective strategies to engage patients with mCSPC in shared decision-making, with the goal of maximizing patient satisfaction, clinical outcomes, and treatment adherence.

Go online to PeerView.com/UDM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The therapeutic landscape for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly in recent years, and research endeavors continue to expand treatment options with significant implications for patients. In addition to the approval of multiple second-generation androgen deprivation therapies (ADTs), current clinical trials are investigating novel targeted therapies, immunotherapies, and combination approaches in different disease settings. Furthermore, when managing patients with mCSPC, clinicians must consider established, newly approved, and emerging therapies, as well as individual patient-, tumor-, and treatment-related factors. Given the wealth of new options, how do clinicians determine the best treatment course for each patient? Answers to this and other thought-provoking queries are provided in this educational activity based on a recent live symposium, as a panel of prostate cancer experts examine the latest clinical data for novel and emerging therapeutic approaches and discuss evidence-based strategies for individualizing treatment for each patient with mCSPC. Upon completion of this activity, participants should be better able to: Assess the rationale and clinical evidence for novel therapeutic approaches for patients with mCSPC, such as the addition of novel androgen axis inhibitors or docetaxel to ADT, Develop optimal, individualized treatment plans for patients with mCSPC that incorporate novel therapeutics as appropriate, taking into consideration individual patient-, disease-, and treatment-related factors, Apply evidence- and team-based strategies to proactively mitigate and manage treatment-related adverse events that may occur in patients with mCSPC who are receiving novel therapeutics as part of their care, Employ effective strategies to engage patients with mCSPC in shared decision-making, with the goal of maximizing patient satisfaction, clinical outcomes, and treatment adherence.

Go online to PeerView.com/UDM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The therapeutic landscape for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly in recent years, and research endeavors continue to expand treatment options with significant implications for patients. In addition to the approval of multiple second-generation androgen deprivation therapies (ADTs), current clinical trials are investigating novel targeted therapies, immunotherapies, and combination approaches in different disease settings. Furthermore, when managing patients with mCSPC, clinicians must consider established, newly approved, and emerging therapies, as well as individual patient-, tumor-, and treatment-related factors. Given the wealth of new options, how do clinicians determine the best treatment course for each patient? Answers to this and other thought-provoking queries are provided in this educational activity based on a recent live symposium, as a panel of prostate cancer experts examine the latest clinical data for novel and emerging therapeutic approaches and discuss evidence-based strategies for individualizing treatment for each patient with mCSPC. Upon completion of this activity, participants should be better able to: Assess the rationale and clinical evidence for novel therapeutic approaches for patients with mCSPC, such as the addition of novel androgen axis inhibitors or docetaxel to ADT, Develop optimal, individualized treatment plans for patients with mCSPC that incorporate novel therapeutics as appropriate, taking into consideration individual patient-, disease-, and treatment-related factors, Apply evidence- and team-based strategies to proactively mitigate and manage treatment-related adverse events that may occur in patients with mCSPC who are receiving novel therapeutics as part of their care, Employ effective strategies to engage patients with mCSPC in shared decision-making, with the goal of maximizing patient satisfaction, clinical outcomes, and treatment adherence.

Go online to PeerView.com/UDM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The therapeutic landscape for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly in recent years, and research endeavors continue to expand treatment options with significant implications for patients. In addition to the approval of multiple second-generation androgen deprivation therapies (ADTs), current clinical trials are investigating novel targeted therapies, immunotherapies, and combination approaches in different disease settings. Furthermore, when managing patients with mCSPC, clinicians must consider established, newly approved, and emerging therapies, as well as individual patient-, tumor-, and treatment-related factors. Given the wealth of new options, how do clinicians determine the best treatment course for each patient? Answers to this and other thought-provoking queries are provided in this educational activity based on a recent live symposium, as a panel of prostate cancer experts examine the latest clinical data for novel and emerging therapeutic approaches and discuss evidence-based strategies for individualizing treatment for each patient with mCSPC. Upon completion of this activity, participants should be better able to: Assess the rationale and clinical evidence for novel therapeutic approaches for patients with mCSPC, such as the addition of novel androgen axis inhibitors or docetaxel to ADT, Develop optimal, individualized treatment plans for patients with mCSPC that incorporate novel therapeutics as appropriate, taking into consideration individual patient-, disease-, and treatment-related factors, Apply evidence- and team-based strategies to proactively mitigate and manage treatment-related adverse events that may occur in patients with mCSPC who are receiving novel therapeutics as part of their care, Employ effective strategies to engage patients with mCSPC in shared decision-making, with the goal of maximizing patient satisfaction, clinical outcomes, and treatment adherence.

Go online to PeerView.com/UDM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The therapeutic landscape for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly in recent years, and research endeavors continue to expand treatment options with significant implications for patients. In addition to the approval of multiple second-generation androgen deprivation therapies (ADTs), current clinical trials are investigating novel targeted therapies, immunotherapies, and combination approaches in different disease settings. Furthermore, when managing patients with mCSPC, clinicians must consider established, newly approved, and emerging therapies, as well as individual patient-, tumor-, and treatment-related factors. Given the wealth of new options, how do clinicians determine the best treatment course for each patient? Answers to this and other thought-provoking queries are provided in this educational activity based on a recent live symposium, as a panel of prostate cancer experts examine the latest clinical data for novel and emerging therapeutic approaches and discuss evidence-based strategies for individualizing treatment for each patient with mCSPC. Upon completion of this activity, participants should be better able to: Assess the rationale and clinical evidence for novel therapeutic approaches for patients with mCSPC, such as the addition of novel androgen axis inhibitors or docetaxel to ADT, Develop optimal, individualized treatment plans for patients with mCSPC that incorporate novel therapeutics as appropriate, taking into consideration individual patient-, disease-, and treatment-related factors, Apply evidence- and team-based strategies to proactively mitigate and manage treatment-related adverse events that may occur in patients with mCSPC who are receiving novel therapeutics as part of their care, Employ effective strategies to engage patients with mCSPC in shared decision-making, with the goal of maximizing patient satisfaction, clinical outcomes, and treatment adherence.

Go online to PeerView.com/UDM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The therapeutic landscape for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly in recent years, and research endeavors continue to expand treatment options with significant implications for patients. In addition to the approval of multiple second-generation androgen deprivation therapies (ADTs), current clinical trials are investigating novel targeted therapies, immunotherapies, and combination approaches in different disease settings. Furthermore, when managing patients with mCSPC, clinicians must consider established, newly approved, and emerging therapies, as well as individual patient-, tumor-, and treatment-related factors. Given the wealth of new options, how do clinicians determine the best treatment course for each patient? Answers to this and other thought-provoking queries are provided in this educational activity based on a recent live symposium, as a panel of prostate cancer experts examine the latest clinical data for novel and emerging therapeutic approaches and discuss evidence-based strategies for individualizing treatment for each patient with mCSPC. Upon completion of this activity, participants should be better able to: Assess the rationale and clinical evidence for novel therapeutic approaches for patients with mCSPC, such as the addition of novel androgen axis inhibitors or docetaxel to ADT, Develop optimal, individualized treatment plans for patients with mCSPC that incorporate novel therapeutics as appropriate, taking into consideration individual patient-, disease-, and treatment-related factors, Apply evidence- and team-based strategies to proactively mitigate and manage treatment-related adverse events that may occur in patients with mCSPC who are receiving novel therapeutics as part of their care, Employ effective strategies to engage patients with mCSPC in shared decision-making, with the goal of maximizing patient satisfaction, clinical outcomes, and treatment adherence.

Guest host Dr. Neeraj Agarwal, of the University of Utah Huntsman Cancer Institute and the ASCO Daily News editor-in-chief, discusses key therapeutic advances in mRCC and mUC, as well as new research that proposes periodic scans to monitor patients with mCSPC for disease progression, with Dr. Jeanny-Aragon-Ching of the Inova Schar Cancer Institute.  Transcript:  Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program, a professor of medicine at the University of Utah Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News.  My guest today is Dr. Jeanny Aragon-Ching, who is a medical oncologist and the Clinical Program Director of Genitourinary Cancers at the Inova Schar Cancer Institute in Virginia.  Today, we will be discussing key posters in genitourinary (GU) oncology that will be featured at the 2022 ASCO Annual Meeting. Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcripts at asco.org/podcast.  Jeanny, it is great to have you on the podcast today.  Dr. Jeanny Aragon-Ching: Thanks, Neeraj. It's a pleasure for me to be here as well.  Dr. Neeraj Agarwal: Jeanny, let's begin with Abstract 4510. This is a trial that represents a growing interest among researchers worldwide in the microbiome and how it is impacted by antibiotics and how it modulates immune checkpoint inhibitor response. Can you tell us about this study?  Dr. Jeanny Aragon-Ching: Thanks, Neeraj, I would be happy to. So, the title of the abstract is, “Characterization of the Microbial Resistome in a Prospective Trial of CBM 588 in Metastatic Renal Cell Carcinoma Offers Mechanism for Interplay Between Antibiotic Use and Immune Checkpoint Inhibitor Activity.”  So, this is an interesting abstract that originated likely from the observation that getting antibiotics while on checkpoint inhibitors typically results in worse outcomes, perhaps because antibiotics can clear the normal gut flora and thereby increase these pathogenic antibiotic-resistant bacteria.  Now, on the other hand, there were some retrospective studies using a live microbial product called CBM 588, which seems to improve outcomes in patients on checkpoint inhibitors and getting antibiotics.  So, the idea, therefore, is that shifting the genes encoding antimicrobial resistance could result in a better checkpoint inhibitor response. So, this Abstract 4510 is a small study conducted by Dr. Nazli Dizman and Dr. Sumanta (Monty) Kumar Pal, and colleagues, and enrolled 29 metastatic clear cell RCC patients with intermediate or poorest disease. And they were stratified into receiving either nivolumab or ipilimumab compared to nivo/IPI with CBM 588.  Now stool samples were collected at baseline in week 12. And they did this whole metagenome sequencing to analyze a stool microbiome composition, and they also looked at the antibiotic resistance genes for the most common classes of antibiotics.  The results showed an astounding improvement in objective responses. So, 58%, for instance, in nivo/IPI and the CBM 588 arm compared to only 20% in the nivo/IPI arm. And it seems like also the antibiotics resistance genes were also decreased in those getting the CBM 588 alongside nivo/IPI. Therefore, responses were improved by shifting the gut microbiome alone. So, these findings were published actually recently by these authors in Nature Medicine. So, in case anyone wants to take a deep dive, it would be a good interesting read for this dataset.  Dr. Neeraj Agarwal: Very interesting, indeed. Jeanny, what is the main message here for our colleagues?  Dr. Jeanny Aragon-Ching: I think, Neeraj, the key takeaway message is that this is a very provocative proof of concept trial that suggests shifting the gut microbiome has the potential to improve responses to checkpoint inhibitors and outcomes. So, this is a very up-and-coming trial and is seen also across the board in other cancers.  Dr. Neeraj Agarwal: Thanks, Jeanny. Moving on to urothelial cancer, there is a poster that I think is a must-see for our colleagues. This is Abstract 4577 titled, “Defining Platinum Ineligible Patients with Metastatic Urothelial Carcinoma.”  Dr. Jeanny Aragon-Ching: So, Neeraj, what can you tell us about this abstract?  Dr. Neeraj Agarwal: So, over the past few years, there has been a tremendous evolution in the treatment landscape for patients with metastatic urothelial carcinoma. For over 40 years the standard of care for these patients has been cisplatin-based chemotherapy.  However, approximately 50% of patients are cisplatin-ineligible, due to underlying comorbidities, and are offered carboplatin as an alternative. So, although the checkpoint inhibitors pembrolizumab and atezolizumab were approved as first-line therapy for these patients in 2017, the U.S. Food and Drug Administration (FDA) has now restricted the use of first-line pembrolizumab to platinum ineligible patients with metastatic urothelial carcinoma.  The challenge we face as oncologists since the FDA restriction is the absence of a formal definition of platinum ineligibility and the inclusion of this definition in the guidelines. So, in Abstract 4577, Drs. Shilpa Gupta and Jonathan Rosenberg, along with the team present an updated consensus definition for platinum ineligibility based on an online survey of 60 genitourinary oncologists in the United States.  Based on the results from this survey, any patient with metastatic urothelial carcinoma, meeting 1 of the following 5 clinical and or laboratory parameters should be considered platinum ineligible, and these are 1 of the following: an ECOG performance status of 3 or more, creatinine clearance of fewer than 30 mils per minute, or peripheral neuropathy of grade 2 or more, or heart failure class of 3 or more—so, this is NYHA heart failure class of 3 or more—and lastly, the combination of performance status of 2 or more, plus a creatinine clearance of less than 30 mils per minute.  Dr. Jeanny Aragon-Ching: Well, this is a timely update, Neeraj. So, what do you think is a key takeaway from this abstract?  Dr. Neeraj Agarwal: These criteria based on simple and easily available clinical and or laboratory parameters will now allow us to readily define platinum ineligibility in our patients with metastatic urothelial carcinoma, which is a need in busy clinics, both in academic and community settings.  So, I think once published and obviously once endorsed by guidelines, we really would like to be able to use this criterion to quickly define platinum ineligibility in our clinics.  Dr. Jeanny Aragon-Ching: Agree. Yeah.  Dr. Neeraj Agarwal: So, Jeanny, let me switch the gears. PSMA testing is a hot topic this year. And there is an abstract that could potentially have an impact on future guidelines, and how we will practice further down the road.  So, I'm referring to the Abstract 5088 titled, “Predictive Value of Extra Prostatic Disease Detection by Preoperative PSMAPET for Biochemical Recurrence-free Survival in Patients with Otherwise Localized Prostate Cancer and Who are Treated with Radical Prostatectomy.”  So, this is a follow-up analysis of a multicenter prospective phase 3 imaging trial. So, could you please tell us more about this abstract where they are using PSMA PET scan in the preoperative localized prostate cancer setting?  Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. So, you may recall that the multicenter prospective phase 3 imaging trial that garnered gallium PSMA approval by the FDA was actually based on this study that looked at the intermediate and high-risk patients with prostate cancer undergoing radical prostatectomy and lymph node dissection, and they underwent prior gallium PSMA PET scanning for pelvic nodal metastases prior to surgery.  So, this was actually previously reported by Dr. Calais and group. Now they are reporting on Abstract 5088 as a post hoc analysis of the same population and group of patients looking for extraprostatic disease. And the final pathology was also correlated to look at nodal disease in these patients in order to predict biochemical recurrence, so they follow these patients for biochemical recurrence occurrence.  So, of the 36% of patients who did undergo radical prostatectomy after they underwent PSMA PET scan, about 41% of them recurred with biochemical recurrence, and 40% of them underwent some kind of salvage therapy or some treatment.  What was very interesting was when they looked at the biochemical recurrence-free survival. It was better in those who were PSMA negative, and that recurrence-free survival was easily about 33 months, compared to only about 7.3 months in those who were PSMA-positive scans.  Furthermore, the ones who had the longest and the highest biochemical recurrence-free survival, intuitively, were those who were node-negative and PSMA PET-negative, so probably not surprisingly. And that rate was about 46 months—close to 4 years. Whereas those who are node-positive on final pathology and their PSMA PET was also positive, they only had about 3 months of biochemical recurrence-free survival.  Dr. Neeraj Agarwal: Very interesting. So, it looks like the PSMA PET scan is predicting biochemical recurrence-free survival in localized prostate cancer settings. So, Jeanny, what is the key takeaway from this trial?  Dr. Jeanny Aragon-Ching: I think, Neeraj, the bottom line is that patients with extraprostatic disease that is detected by their preoperative PSMA PET scan does predict strongly a high risk of biochemical relapse, and this can really be an additional tool that clinicians can use to help inform and guide future therapy.  Dr. Neeraj Agarwal: Thanks, Jeanny. The research on preoperative PSMA testing and its implications on future treatment strategies in the setting is going to be really interesting to watch in the very near future.  Dr. Jeanny Aragon-Ching: Yes, absolutely. I really think we should also discuss Abstract 5072, along those lines, the importance really of radiographic monitoring for disease progression in patients with metastatic hormone-sensitive prostate cancer.  Dr. Neeraj Agarwal: Yes, thanks for reminding and this is Abstract 5072. This is a post hoc analysis of the ARCHES trial, titled, “Radiographic Progression in the Absence of PSA Progression in Patients with Metastatic Hormone-sensitive Prostate Cancer.”  During the last several years, we have seen many of these agents typically given for gastric resistant prostate cancer moving upfront to the castration-sensitive prostate cancer setting. This is especially true for androgen receptor access targeting agents such as abiraterone, enzalutamide, and apalutamide, all being now approved for patients with metastatic castration-sensitive prostate cancer.  What is noteworthy from all these trials, and is reported in Abstract 5072, is the use of imaging studies to evaluate disease progression. So, in Abstract 5072, Dr. Andrew Armstrong and Dr. Arun Azad performed a post hoc analysis of the ARCHES trial to investigate the concordance between radiographic progression and the PSA Progression as defined by PCWG2 criteria, or between radiographic progression and any rise in the PSA above nadir, in patients who were being treated with this novel hormonal therapies, in this case, enzalutamide for metastatic castration sensitive prostate cancer.  And as a quick reminder, ARCHES was a phase 3 trial that showed a significant reduction and radiographic progression-free survival and improved overall survival for patients with metastatic castration sensitive prostate cancer treated with enzalutamide plus androgen deprivation therapy (ADT) versus those treated with placebo plus androgen deprivation therapy.  So, very interestingly, the findings from this study indicate that 67% of patients on the enzalutamide plus ADT arm did not have [Prostate Cancer Clinical Trials Working Group 2 criteria] PCWG2-defined prostate-specific antigen (PSA) progression at the time of radiographic progression. And discordance was present in the ADT-only arm as well, where they found 42% of patients on the ADT-only arm had radiographic progression but did not have PCWG2-defined PSA progression.  Interestingly, this discordance of radiographic disease progression was also seen with any rise in the PSA above nadir. And I personally found this information to be very clinically relevant when we are seeing the majority of patients actually experiencing radiographic disease progression, not experiencing PSA progression at the same time.  Dr. Jeanny Aragon-Ching: Yeah, absolutely. I agree with that, Neeraj. So, very interesting data. So, what do you think is the key takeaway message for the clinicians listening to us?  Dr. Neeraj Agarwal: I'll make the message very simple. I think the message is that patients with metastatic castration-sensitive prostate cancer need to be monitored for disease progression with periodic scans, and PSA monitoring alone is not sufficient in the majority of these patients.  Again, we cannot undervalue the role of periodic imaging studies in these patients so that we can timely diagnose them to have disease progression.  Dr. Jeanny Aragon-Ching: I agree with that.  Dr. Neeraj Agarwal: Jeanny, the last abstract I would like to mention before we wrap up the podcast is Abstract 4509, the results from the phase1 live SPARC 001 study. So, can you please tell us more about this study titled, “Phase-1 Live SPARC 001: The Study of Belzutifan in Advanced Solid Tumors,” which is an update of the renal cell carcinoma cohort with more than 3 years of total follow up?  Dr. Jeanny Aragon-Ching: Thanks, Neeraj. So, while the current therapeutic landscape for patients with metastatic clear cell renal cell carcinoma (RCC) has changed dramatically over the past several years, with significant improvement in patient outcomes. Most patients unfortunately still experience disease progression on current treatments.  So, in-depth molecular profiling of clear cell RCC has revealed recurrent loss of function mutations in VHL in actually greater than 90% of patients. So, the VHL protein, as you will recall, is part of the oxygen-sensing pathway, regulating levels of HIF which is hypoxia-inducible factor protein, it's a transcriptional activator that mediates the response to hypoxic conditions. So, HIF-2α is a key oncogenic driver in RCC.  So, previous data you may recall from the phase-1 Live SPARC 001 trial was designed to evaluate belzutifan so, this was a novel HIF-2α inhibitor which showed durable anti-tumor activity and acceptable safety profile in patients with metastatic clear cell RCC.  So, in Abstract 4509, Drs. Jonasch and Toni Choueiri presented updated results from this trial after more than 3 years of follow-up. Of the 55 patients enrolled 16% of patients remained in treatment. And 62% of patients had discontinued treatment because of, unfortunately, disease progression.  The median progression-free survival (PFS) for the total cohort was 14.5 months. And the overall disease control rate was 80%. Forty percent of patients experienced grade 3 treatment-related adverse events with the most frequent ones being anemia and hypoxia.  There were no great 4 or 5 treatment-related adverse events. And these results, therefore, show that belzutifan monotherapy continues to show a high rate of disease control and a safety profile in a heavily treated population of patients with metastatic RCC. So, it is great to see that there were no new safety signals.  Dr. Neeraj Agarwal: Very nice data indeed. So, Jeanny, what is the key takeaway message here for our listeners?  Dr. Jeanny Aragon-Ching: Yeah, I think the message here is that the use of belzutifan monotherapy continues to show efficacy and safety in patients with metastatic clear cell RCC, which have progressed on multiple prior contemporary therapies, and there are phase 3 trials currently underway.  Dr. Neeraj Agarwal: Jeanny, any final thoughts before we wrap up the podcast today?  Dr. Jeanny Aragon-Ching: Thanks, Neeraj. I think it's a really exciting time to be in genitourinary (GU) oncology, and I'm truly looking forward to seeing some great sessions at the 2022 ASCO Annual Meeting.  Dr. Neeraj Agarwal: Thank you, Jeanny, for sharing your insight with us today. It was a great conversation. And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News podcast, please take a moment to rate, review, and subscribe wherever you get your podcast.    Disclosures:   Dr. Neeraj Agarwal:   Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences  Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, Arvinas  Dr. Jeanny Aragon-Ching:   Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc  Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, AstraZeneca/MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis  Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb , Astellas/Seattle Genetics  Travel, Accommodations, Expenses: Dendreon, Algeta/Bayer, Bristol Myers Squibb, EMD Serono, Astellas Pharma  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 expressed 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.       

COR2ED Medical Education: Dr Alicia Morgans, Genitourinary Medical Oncologist at the Dana-Farber Cancer Institute in the United States and Dr. Neal Shore, Uro-Oncologist and Chief Medical Officer for Genesis Care and Urology and Surgical Oncology in the United States discuss ‘Prostate Cancer Highlights from ASCO GU 2022’ in this GU CONNECT podcast. In this podcast, the experts review data from a number of key plenary sessions from ASCO GU 2022 and discuss potential implications for clinical practice. The ARASENS trial is covered first which looked at triplet therapy in the form of ADT plus docetaxel and darolutamide in patients with metastatic castration sensitive prostate cancer (mCSPC). Discussion then moves to two trials investigating the combination of abiraterone acetate with PARP inhibitors in metastatic castration resistant prostate cancer (mCRPC) patients with and without homologous recombination repair (HRR) mutations: the PROpel trial with olaparib and the MAGNITUDE trial with rucaparib. Neal and Alicia also discuss a fascinating presentation by Dr. Daniel Spratt which looked at digitising histopathology slides and using Artificial Intelligence (AI) to inform on the likelihood of disease progression and whether or not patients needed androgen deprivation therapy (ADT) Finally, Alicia discusses a number of posters which she felt made an impact, including one on PSA responses in the TITAN and SPARTAN trials and a secondary analysis from the VISION trial looking at treatment related adverse events, amongst others.

Guest host, Dr. Neeraj Agarwal, editor-in-chief of ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, and Dr. Jason Efstathiou, chair of the 2022 ASCO Genitourinary Cancers Symposium, discuss key abstracts and innovations in GU oncology featured at #GU22. Dr. Efstathiou is professor at Harvard Medical School and director of the Genitourinary Division in Radiation Oncology at Massachusetts General Hospital.   Transcript Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I am Dr. Neeraj Agarwal, the director of the Genitourinary Program and professor of medicine at the University of Utah Huntsman Cancer Institute and editor in chief of the ASCO Daily News. Today we'll be discussing key advances in GU oncology featured at the 2022 ASCO Genitourinary (GU) Cancers Symposium. I'm delighted to welcome Dr. Jason Efstathiou, who was the chair of this year's GU ASCO meeting. Dr. Efstathiou is the professor at Harvard Medical School and the director of Genitourinary Division in Radiation Oncology and clinical co-director of The Claire and John Bertucci Center for GU Cancers at the Massachusetts General Hospital. Our full disclosures are available in the show notes and the disclosure of all guests on the podcast can be found on our transcript at asco.org/podcast. Jason, thank you for coming on the podcast today.   Dr. Jason Efstathiou: Thank you very much, Neeraj. It's a real pleasure to be with you.   Dr. Neeraj Agarwal: So, Jason, the GU meeting showcased some fantastic advances across the spectrum of GU malignancies, can you please tell us about some of the hot topics that made the headlines this year?   Dr. Jason Efstathiou: Absolutely. This certainly was a dynamic and interactive hybrid ASCO GU meeting for all those attending in person, live streaming, or accessing the content on demand. With over 5,200 registrants this year, that's an actual record for this meeting and over 70 countries represented. This meeting truly serves as the premier global event for all those who diagnose, treat and study GU cancers. The meeting highlighted novel scientific and clinical findings that were high impacted. [And] in many cases will lead to practice changing care. The meeting had a real focus on diversity, global perspectives, enhanced interactivity, networking, multidisciplinary, collaborative, and evidence-based care. As you know, this year's theme was “World Class Science, Patient-Centered Care,” and this theme was highlighted throughout the program. The meeting kicked off with a rich day focusing on prostate cancer, lots on PSMA imaging, such as Abstract 9 and a very, very excellent session on PSMA targeting and beyond which explored opportunities and challenges with PSMA novel therapeutics, including biomarkers of response and mechanisms of resistance.   Then Abstract 10 looked at PSMA PET and FDG PET as predictors of response and prognosis in a randomized phase 2 trial of Lutetium PSMA (177Lu-PSMA-617) vs cabazitaxel and metastatic castration-resistant prostate cancer (CRPC) progressing after docetaxel. And it suggested that Lutetium PSMA be prioritized in men with high PSMA expression. And this could actually be predictive. We had some awesome abstracts. Abstracts 222 and 223 suggested that a nozzle digital pathology-based biomarker developed using artificial intelligence is more effective than clinical prognostic markers for predicting long term outcomes in patients with prostate cancer. And that this AI tool can actually successfully guide the use of androgen deprivation therapy in men with intermediate risk localized prostate cancer. And then of course, there were some very exciting results in discussion with the primary results of 3 potentially practice-changing phase 3 trials in the setting of metastatic prostate cancer that were presented in the oral prostate session. These were: PROpel (Abstract 11), MAGNITUDE (Abstract 12), and the ARASENS trials (Abstract 13). Neeraj, as a practicing medical oncologist, what did you think of these 3 abstracts?   Dr. Neeraj Agarwal: I agree with you, Jason. These are indeed practice-impacting, practice-changing abstracts, which was a record for a prostate oral session, all 3 abstracts. In fact, the results of the phase 3 trials are [likely] going to influence or impact our practice in coming months. I would like to start with Abstract 11 on the results of the PROpel trial. So, PROpel is a randomized phase 3 trial evaluating the efficacy and safety of olaparib plus abiraterone vs placebo plus abiraterone. In the first-line metastatic cast of resistant cluster cancer, docetaxel therapy was allowed for these patients if given in the metastatic castration sensitive prostate cancer setting. Enrollment in the study was independent of the defects in the homologous recombination repair gene pathway. The primary endpoint was investigator assessed radiographic progression-free survival with multiple secondary endpoints, including overall survival and safety. A total of 796 patients were randomly assigned to olaparib plus abiraterone or placebo plus abiraterone at the pre-plant interim analysis.   Results show that with a significant improvement in the radiographic progression-fee survival for all patients receiving the combination therapy, regardless of the presence of homologous recombination repair gene mutations. Overall survival analysis is still immature with only 29% event having occurred thus far. It is interesting that even patients deemed a negative for homologous recombination repair gene mutations showed significant improvement in video graphic progression-free survival when treated with the combination of olaparib plus abiraterone versus placebo plus abiraterone. I would like to mention the MAGNITUDE trial, which is Abstract 12, in the same context, as these have very similar populations and combination regimens.   So, MAGNITUDE is a randomized phase 3 trial evaluating the efficacy and safety of niraparib plus abiraterone vs placebo plus abiraterone in the first-line metastatic castrate resistant prostate cancer setting. The eligible patient population was slightly different from that in the PROpel trial—prior attacks in therapy or novel hormonal therapy in the metastatic castration sensitive prostate cancer or non-metastatic castrate resistant prostate cancer were allowed. Also, patients were eligible if they had received up to 4 months of abiraterone in the first-line metastatic CRPC setting. Prospective selection of the patients with, and without homologous recombination repair gene mutations was required.   So, the primary endpoint was radiographic progression-free survival by central with multiple secondary endpoints, including overall survival and safety. A pre-specified early fragility analysis was planned after enrolling 200 patients who are [homologous recombination repair] (HRR) negative and who were randomly assigned to receive either niraparib plus abiraterone or placebo plus abiraterone. The pre-planned fertility analysis showed no benefit in the biomarker negative cohort. Four hundred and twenty-three patients who were HRR positive were randomly assigned to receive either the combination of niraparib plus abiraterone or placebo plus niraparib at the pre-planned interim analysis. The results show that trial method—primary endpoint with a significant improvement in the radiographic progression-free survival for BRCA1 and 2 patients—and all patients who are homologous recombination repair mutation positive [were] receiving the combination of niraparib plus abiraterone versus placebo plus niraparib. Overall survival reserve is still immature.   My combined take on the PROpel and the MAGNITUDE trial, based on the data presented so far or available in the public domain so far, is that both trials establish that combination of a PARP inhibitor plus abiraterone on in the first-line settings for me, for [patients with] HRR mutation positive metastatic castration resistant prostate cancer [will] improve radiographic progression-free survival. Even though overall survival data immature for both trials, I expect both combinations will be approved by the U.S. Food and Drug Administration in the near future and will be available to our patients. The HRR negative in the PROpel trial also seemed to benefit with the combination of abiraterone plus olaparib.   I'm looking forward to data on confirmation of HRR negative status by tissue-based genomic profiling results in the full-length publication, which we expect to be published soon. If indeed confirmed, I see the combination of abiraterone plus olaparib to be reasonable option for patients who are HRR negative in the first metastatic castration prostate cancer set. The last practice changing abstract in the oral prostate session was Abstract 13 on the results of the ARASENS trial. ARASENS is a randomized phase 3 trial evaluating the efficacy and safety of darolutamide plus ADT or androgen deprivation therapy plus docetaxel versus placebo plus ADT plus docetaxel in patients with metastatic castration sensitive prostate cancer or mCSPC.   It is important to note that this study only included patients that were eligible for ADT plus docetaxel chemotherapy. The primary endpoint was overall survival with multiple secondary endpoints, including time to casted resistance, time to pain progression, time to first symptomatic skeletal event, and time to start of next antineoplastic therapy and of course, safety. A total of 1,300 patients were randomly assigned to the darolutamide plus ADT plus docetaxel vs placebo plus ADT plus docetaxel.   Results show the primary endpoint of the study was met with a significant improvement in overall survival and a 32% reduction in risk of death for patients on the triplet therapy with thalidomide plus ADT plus docetaxel. While this study offers an additional excellent option for our patients with metastatic castration sensitive prostate cancer, in an older patient population [the] use of docetaxel may be a significant limitation to this combination. In addition, this study did not answer the question [of] if adding docetaxel to ADT plus a novel hormonal therapy backbone will also improve survival with the advent of multiple doublets and triplet combinations. In the recent years, it is very important to find biomarkers which may predict response to these treatments and personalized therapy.   Dr. Jason Efstathiou: Well, Neeraj, it certainly is a mic drop moment. Isn't it? When you can announce that the New England Journal of Medicine has just released the publication of your ARASENS trial, as you're presenting it at ASCO GU don't you think (DOI: 10.1056/NEJMoa2119115)?   Dr. Neeraj Agarwal: Indeed, I think this is one of the most exciting ASCO GU meetings I've seen ever from GU ASCO. This is not an exaggeration.   Dr. Jason Efstathiou: I totally agree. It was a phenomenal meeting and a very dynamic rich prostate day.   Dr. Neeraj Agarwal: So, let's move on to the bladder cancer. Jason, what are your key takeaways from the studies of bladder cancer presented in this meet?   Dr. Jason Efstathiou: Thanks, Neeraj. Yeah, the sessions on urothelial cancer were phenomenal and there were great sessions on novel therapies, such as antibody drug conjugates in advanced urothelial cancer and management of toxicities. There were abstracts such as [Abstract] 440 suggesting that neoadjuvant gemcitabine and cisplatin produced a favorable pathologic response rate and was well tolerated in patients with high grade upper tract urothelial carcinoma, and thus should be potentially deemed a new standard. Abstract 442 was a phase 2 trial that suggested that maintenance treatment with niraparib plus best supportive care did not improve outcomes compared to best supportive care alone, in patients with advanced urothelial carcinoma that did not progress after first-line chemotherapy.   There was Abstract 435, which was an earlier face study suggesting that neoadjuvant treatment with enfortumab demonstrated promising activity among patients who are cisplatin ineligible with muscle invasive bladder cancer. And then there was a lot of focus in the meeting on trimodality therapy and optimizing bladder preservation. Dr. Alexandre R. Zlotta presented Abstract 433, which was a large multi-institutional match comparison of radical cystectomy to trimodality therapy for patients with muscle-invasive bladder cancer. And it suggested equivalent oncologic outcomes for select patients, and that trimodality therapy should be offered as an effective alternative for these patients. So Neeraj, moving on to kidney cancer, what were your key takeaways from these studies on kidney cancer presented in this meeting?   Dr. Neeraj Agarwal: Yes, Jason, thank you. There were exciting results presented from multiple studies in kidney cancer as well. For example, Abstract 290 presented by Dr. Toni K. Choueiri from the Dana-Farber Cancer Institute on the 30-month follow-up of the KEYNOTE-564, which showed continued and strong disease-free survival benefit with adjuvant pembrolizumab in the context of localized or completely dissected renal cell carcinoma. I would like to highlight that highest benefit was seen in those patients who had oligometastatic disease, who on different surgery to remove those metastatic foresight and then were randomly assigned to receive pembrolizumab vs placebo in this trial. Abstract 291, presented by Dr. Matthew Zibelman from Fox Chase Cancer Center, showed the combination of axitinib with nivolumab was associated with close to 70% objective responses. Abstract 300 on kidney cancer on more than 1,000 patients—and on the International Metastatic Renal Cell Carcinoma Consortium, or IMDC Consortium—show that in the context of first-line immunotherapy regimens, presence of lung metastasis, CT nephrectomy and better MDC risk scores correlated with improved objective responses on this novel immunotherapy regimens.   Abstract 350 on the update of the cabozantinib nivolumab was a sunitinib trial in metastatic renal cell carcinoma in the first-line setting. And it showed that the combination of cabozantinib nivolumab continues to be associated with an improved survival with the 30% reduction risk of death, even after this longer follow up—approximately 3 years. So, indeed, multiple abstracts on kidney cancer with real impact on how we practice medicine. So, Jason, let me switch gears here and talk about the education session. For example, there was a compelling keynote addressed by Dr. Karen Knudsen, the CEO of the American Cancer Society, about disparities in GU cancers in the United States. Are there any key messages that you would like to highlight briefly before we wrap up the podcast today?   Dr. Jason Efstathiou: Thanks, Neeraj. Absolutely. The educational sessions were phenomenal. There was a must-see session, by the way, on management of rare variants in GU cancers. They made management of nuanced, rare variants and rare situations, very practical. And then there was an exciting prostate focus session called “Regulating the Wild West: PET-Based Imaging in Trials and the Clinic.” This session was planned with representatives from the U.S. Food and Drug Administration as we have done for the past 3 years. But this year it looked at how often PET based imaging affects clinical decision making and prostate cancer and how the integration of novel molecular based imaging like PET informs clinical trial design and endpoints, including regulatory considerations. And yes, of course, as you noted this year's program also focused on identifying and addressing disparities in cancer care and research with sessions each day, focused on this topic (Abstract 225, 446, 472, and 26). There were great oral presentations and there was a phenomenal Virtual Poster Walk with Dr. Ahmedin Jemal from the American Cancer Society. He, by the way, is an author that we have all quoted. So, please check that out. But we were thrilled, absolutely thrilled to have Dr. Karen Knudsen, the CEO of the American Cancer Society (ACS) as our keynote speaker to address this important topic in her phenomenal and frankly, inspiring talk called “A Path Forward: Addressing Disparities in Genitourinary Cancers.” This talk was especially poignant because as you know, there is a new and robust collaboration between ASCO and the ACS that was announced earlier this month on February 1, regarding equity, diversity, and inclusion in cancer care. ASCO's work aims to address all of the important differences that can impact access to cancer care and outcomes, including age, gender, race, sexual orientation, and geography, both in the U.S. and internationally. ASCO has clearly aligned its equity, diversity, and inclusion (EDI) goals within the mission pillars of research, education, and quality.   Dr. Neeraj Agarwal: Thank you, Jason, for sharing your insights with us today. It is really an exciting time in GU oncology. Thank you.   Dr. Jason Efstathiou: Thank You, Neeraj. I totally agree.   Dr. Neeraj Agarwal: And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you like what you're hearing on the ASCO Daily News podcast, please take a moment to rate, review and subscribe wherever you get your podcast. Thank you so much.   Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas   Dr. Jason Efstathiou: Consulting or Advisory Role: Blue Earth Diagnostics, AstraZeneca, Boston Scientific, Roivant Pharma, Merck, and Myovant Sciences   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. Guests' 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.  

Dr. Karim Fizazi, medical oncologist at Gustave Roussy and professor in Oncology at the University of Paris-Saclay in France, tells guest host, Neeraj Agarwal, editor-in-chief of ASCO Daily News and director of the Genitourinary Cancers Programs at the University of Utah's Huntsman Cancer Institute, about the practice-changing PEACE-1 trial, an ongoing phase 3 trial among men diagnosed with de novo metastatic castration-sensitive prostate cancer.   Transcript: Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of Genitourinary Oncology Program and professor of medicine at the University of Utah Huntsman Cancer Institute and editor-in-chief of the ASCO Daily News. Our topic today is the practice-changing PEACE-1 trial, an ongoing phase 3 trial among men with de novo metastatic castration-sensitive prostate cancer.   Joining me today to discuss the results of this trial is Dr. Karim Fizazi, who is a world-renowned medical oncologist practicing at Gustave Roussy and a full professor in Oncology at the University of Paris-Saclay in Villejuif, France. Dr. Fizazi has led multiple practice-changing trials in advanced prostate cancer and is also the founder of the Prostate Cancer Consortium in Europe known as PEACE Consortium. Our full disclosures are available in the show notes, and disclosures related to all episodes of the podcast can be found on our transcripts at the asco.org podcasts. Welcome, Karim. It is so great to have you on the podcast today, and thank you so much for taking time to be with us.   Dr. Karim Fizazi: Thank you very much, Neeraj. It's a pleasure and an honor.   Dr. Neeraj Agarwal: You recently presented the primary results of the phase 3 PEACE-1 trial in men with de novo metastatic castration-sensitive prostate cancer in the ESMO 2021 meeting. Could you please tell us more about the design of this study and why you did this study?   Dr. Karim Fizazi: Sure, yes, happy to do so. So, PEACE-1 is a large academic European phase 3 trial, which is enrolling patients with de novo metastatic prostate cancer. And it is basically asking 2 questions. Number 1, should we add abiraterone acetate on top of standard of care for these men? And in most of them, standard of care consisted in androgen prevention therapy plus chemotherapy with docetaxel. So, this is the number 1 question—in other words, 3 drugs instead of just 2.   And the second question is whether we should use radiation therapy directed to the primary cancer in these men who are treated with intensive systemic treatments? And we're doing that because we already know the answer regarding the radiation question, and it's a yes answer for men who received androgen deprivation therapy (ADT) alone, but we don't really know whether this applies when intensified treatment is being used.   So, it's a 2x2 design, and we were able to enroll almost 1,200 men in the trial. We completed the inclusion in the trial back in 2018, so the patients or at least those who are alive are on follow-up. And this year, 2021, we have analyzed the co-primary endpoints of radiographic progression-free survival and overall survival for the abiraterone equation. In probably 1 or 2 years from now, we will be able to do the same thing regarding the radiation therapy equations when we have sufficient number of events for these patients.   Dr. Neeraj Agarwal: Very interesting trial design and massive effort at the multinational level in Europe. So please tell us about the results of the study and how it will affect the current treatment paradigm of our patients with de novo metastatic castration-sensitive prostate cancer.   Dr. Karim Fizazi: Sure. So, as I said, right now, we have data regarding the abiraterone question. And again, the question is whether we should use ADT plus docetaxel with or without abiraterone acetate and prednisone. At ASCO [Annual Meeting] this year, we reported the radiographic progression-free survival data, which is a co-primary endpoint of the trial, and this is clearly positive (Abstract 5000). If patients received 3 agents—ADT, docetaxel, and abiraterone—they will enjoy 4.5 years without radiographic progression or death in the experimental arm versus only 2 years in the control arm. So, in other words, this mean 2 and a half year of additional life without problems, if you will, without a significant progression or death for this patient, which is big.   I think many people were already convinced with this data and thought this could be practice changing. I remember our discussion, you and me, Neeraj, at this time. But some others were not necessarily convinced and request the overall survival data before making their decision. Or if it's possible to collect the events, and of course, in the COVID-19 times, this has been challenging. But I think we made it, and we were able to show the data for overall survival at ESMO this year in September. And of course, this was planned—pre-planned and dependent on a pre-planned number of events, which was reached. The news here is good again. And actually, patients receiving ADT plus docetaxel plus abiraterone clearly have an improvement significantly by overall survival as compared to those who received just 2 treatments. The reduction in the risk of death was approximately 25% for these patients receiving the triplet treatment, and it's even greater for men with what we call high-volume disease, so those with multiple bone metastases, at least 4, or visceral metastases, of course, men with a poor outcome. For these men, the reduction in the risk of death achieved by the triplet treatment was 28% in reduction of risk of death and was translated in a marked difference in medians, 3.5 years in the control arm with ADT plus docetaxel, and this was actually what we were expecting for this population of men, as compared to 5.1 years for patients receiving the triplet treatment. So, in other words, it's more than 1 and a half additional year of life for these men receiving 3 treatments up front.   I think what is very unique also in this trial is that men in the control arm were treated very aggressively when they progressed. And actually, more than 80% of them received at least one next-generation hormonal agents, and basically, 85% of them received at least 1 drug associated with proven life prolongation. Again, this is in marked contrast to what we saw in previous pharma industry-sponsored trial conducted in the past, where patients in the control arm were not necessarily very aggressively treated. This is clearly showing us that—   Dr. Neeraj Agarwal: Yeah. This is very interesting. I was really impressed by the fact that patients in control arm and as well as experimental arm—so basically patient on ADT plus docetaxel versus ADT plus docetaxel plus abiraterone—more than 80% patients were receiving subsequent life prolonging therapies, which is in marked contrast to other trials we have seen in the recent past. And despite that, you were able to show a remarkable, clinically meaningful improvement in overall survival with the triplet therapy. I think that is the most important message I got from the updated presentation in ESMO 2021. Would you agree?   Dr. Karim Fizazi: Absolutely. I think it's truly a demonstration that early intensification is better than use—a subsequent use of these agents when the cancer is already more heterogeneous, more aggressive, and harder to treat. We should intensify treatment up front. I think this is very important, especially those with predicted poor outcome.   Dr. Neeraj Agarwal: So, Karim, these data are obviously very impressive, in my view, practice changing. Many of my community oncology colleagues have asked me about the potential side effects of this combination versus chemotherapy with docetaxel or abiraterone therapy alone in addition to ADT. Any tips for our colleagues and friends out there in the community on how to manage side effects or what should we be looking for as a community? What should we be telling the patients and any tips on managing the side effects?   Dr. Karim Fizazi: Absolutely. I think this is a key question, and also, this was great news from the trial. We couldn't find basically synergistic toxicity between docetaxel and abiraterone in the trial. So, in other words, what we saw was the expected toxicity from docetaxel, and we expected toxicity from abiraterone, but nothing additional or nothing worse, if you will. For example, the neutropenic fever incidence was exactly the same in the two arms. The GI toxicity from docetaxel was not increased, and actually, it was even a bit less, numerically speaking at least.   And regarding the abiraterone toxicity, what we saw mainly was an excess in hypertension, usually of lower grade, and an excess in transaminase increase, which was actually rare, approximately 6% if I recall well, which is really in line with what you would expect with the general use of this agent. And of course, this is something you can monitor, and you should monitor. We know how to handle toxicity with abiraterone, and the same also applies to the hypertension management with this agent.   Dr. Neeraj Agarwal: Got it. So, say a patient is hesitant, and of course, this was not addressed by the clinical trial. But given compelling survival benefit, if I'm talking to a patient in the clinic tomorrow morning and the patient is hesitant to start all 3 drugs at the same time, do you think it would be reasonable to start chemotherapy with docetaxel, finish 4 to 6 cycles, and then start abiraterone? With the caveat that this was not addressed by the trial, but I'm just asking a very practical question.   Dr. Karim Fizazi: Again, this is a difficult question you're asking. And I'm saying that because, as you rightly said, in PEACE-1 we combined abiraterone with docetaxel. So, in other words, abiraterone was given concomitantly with docetaxel and then was continued when docetaxel was stopped. So, we don't really know whether giving abiraterone as a maintenance strategy, if you will, in your example, post docetaxel would be associated with the same benefit. It's probably reasonable to think it does, but it's not a given. So, my preference would be actually to combine up front, if possible, of course.   Dr. Neeraj Agarwal: Absolutely. And as I said, this was not tested or addressed by the trial. So final message is, as far as combination therapy is concerned, there is no synergy—there is synergy with the efficacy, but we are not seeing synergy, if you will, from the side effect perspective. And if we are deciding to start triplet therapy, we should be starting all drugs at the same time. At least docetaxel and abiraterone should be started together and not sequenced. Any final message for our friends and colleagues in the community by you, Karim?   Dr. Karim Fizazi: Well, maybe just 1 or 2 final messages. The 1 is a hurrah message because I'm happy, of course, with the data. And just to put this into perspective, back in 2015, before we had all of the recent trials in M1 castration-sensitive disease, men with high-volume disease had approximately 3 years of life expectancy. And now just 5 or 6 years afterwards, thanks to all clinical research we conducted during this time frame, in PEACE-1, these patients can live more than 5 years, which I think is remarkable.   I think the second and last message is that we should soon have more data for these men regarding the triplet combination with ADT, docetaxel, and a next-generation hormonal agent. Specifically, the ARASENS trial (NCT02799602), which is testing darolutamide randomly in this setting, is to release its data probably very soon. And the same applies to the enzalutamide trial with ENZAMET, which should be updated specifically for these men receiving the triplet treatment. So, we should see even more data than what I was fortunate enough to report this year with PEACE-1.   Dr. Neeraj Agarwal: Thank you. So, thank you, Karim, again, for sharing these exciting data from the PEACE-1 trial. Congratulations for conducting this massive trial and coming out with such great news for our patients. I wish you all the best.   Dr. Karim Fizazi: Thank you very much, Neeraj. It was a pleasure. Thank you so much.   Dr. Neeraj Agarwal: And thank you to our listeners for your time today. If you enjoyed this podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you very much.   Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Foundation Medicine, Gilead Sciences Research Funding (inst.): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas   Dr. Karim Fizazi: Honoraria (inst.): Janssen, Sanofi, Astellas Pharma, Bayer Consulting or Advisory Role (inst.): Janssen Oncology, Astellas Pharma, Sanofi, AstraZeneca, ESSA, Amgen, Bristol-Myers Squibb, Clovis Oncology Consulting or Advisory Role: Curevac, Orion Pharma GmbH, Bayer Travel, Accommodations, Expenses: Janssen, MSD   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. Guests' 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.  

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/BCF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. A new, expert-led MasterClass from PeerView and the Us TOO International Prostate Cancer Education & Support Network will provide guidance on individualizing treatment regimens for patients with prostate cancer and will address the latest clinical evidence and guidelines/expert consensus recommendations. The program will also offer information on relevant patient-, tumor-, and treatment-related factors, as well as how to handle patients' specific needs and preferences. Upon completion of this activity, participants should be better able to: Review recent safety and efficacy data of emerging and available agents across the prostate cancer disease continuum (nmCRPC, mCSPC, mCRPC), including the latest evidence and expert recommendations for selection and sequencing of approved hormonal and chemotherapy options, Outline the latest clinical evidence for appropriate use of novel therapies (eg, PARP inhibitors and immunotherapy) in mCRPC, including monotherapy and combination approaches, Evaluate the latest genetic testing guidelines to better direct treatment decision-making throughout the prostate cancer disease continuum, Develop evidence-based, tailored treatment plans, including the option of clinical trial enrollment, for patients with prostate cancer, based on disease-, patient-, and treatment-specific factors.

Go online to PeerView.com/QAT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in urologic oncology discusses hormonal therapy in prostate cancer. Upon completion of this activity, participants should be better able to: Summarize the recent safety and efficacy data on novel hormonal therapy for metastatic castration-sensitive prostate cancer (mCSPC), as well as for other prostate cancer settings including castration-resistant (nmCRPC and mCRPC) disease, Counsel patients on current hormonal therapy standards for personalized management of prostate cancer, including for treatment selection based on disease progression, prior therapy, and patient characteristics, Design individualized, evidence-based treatment plans for patients with prostate cancer, taking into consideration disease, treatment, and patient-specific factors, Manage the spectrum of adverse events associated with novel hormonal therapies in patients with prostate cancer.

Go online to PeerView.com/QAT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in urologic oncology discusses hormonal therapy in prostate cancer. Upon completion of this activity, participants should be better able to: Summarize the recent safety and efficacy data on novel hormonal therapy for metastatic castration-sensitive prostate cancer (mCSPC), as well as for other prostate cancer settings including castration-resistant (nmCRPC and mCRPC) disease, Counsel patients on current hormonal therapy standards for personalized management of prostate cancer, including for treatment selection based on disease progression, prior therapy, and patient characteristics, Design individualized, evidence-based treatment plans for patients with prostate cancer, taking into consideration disease, treatment, and patient-specific factors, Manage the spectrum of adverse events associated with novel hormonal therapies in patients with prostate cancer.

Go online to PeerView.com/QAT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in urologic oncology discusses hormonal therapy in prostate cancer. Upon completion of this activity, participants should be better able to: Summarize the recent safety and efficacy data on novel hormonal therapy for metastatic castration-sensitive prostate cancer (mCSPC), as well as for other prostate cancer settings including castration-resistant (nmCRPC and mCRPC) disease, Counsel patients on current hormonal therapy standards for personalized management of prostate cancer, including for treatment selection based on disease progression, prior therapy, and patient characteristics, Design individualized, evidence-based treatment plans for patients with prostate cancer, taking into consideration disease, treatment, and patient-specific factors, Manage the spectrum of adverse events associated with novel hormonal therapies in patients with prostate cancer.

Go online to PeerView.com/QAT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in urologic oncology discusses hormonal therapy in prostate cancer. Upon completion of this activity, participants should be better able to: Summarize the recent safety and efficacy data on novel hormonal therapy for metastatic castration-sensitive prostate cancer (mCSPC), as well as for other prostate cancer settings including castration-resistant (nmCRPC and mCRPC) disease, Counsel patients on current hormonal therapy standards for personalized management of prostate cancer, including for treatment selection based on disease progression, prior therapy, and patient characteristics, Design individualized, evidence-based treatment plans for patients with prostate cancer, taking into consideration disease, treatment, and patient-specific factors, Manage the spectrum of adverse events associated with novel hormonal therapies in patients with prostate cancer.

Go online to PeerView.com/QAT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in urologic oncology discusses hormonal therapy in prostate cancer. Upon completion of this activity, participants should be better able to: Summarize the recent safety and efficacy data on novel hormonal therapy for metastatic castration-sensitive prostate cancer (mCSPC), as well as for other prostate cancer settings including castration-resistant (nmCRPC and mCRPC) disease, Counsel patients on current hormonal therapy standards for personalized management of prostate cancer, including for treatment selection based on disease progression, prior therapy, and patient characteristics, Design individualized, evidence-based treatment plans for patients with prostate cancer, taking into consideration disease, treatment, and patient-specific factors, Manage the spectrum of adverse events associated with novel hormonal therapies in patients with prostate cancer.

Go online to PeerView.com/QAT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in urologic oncology discusses hormonal therapy in prostate cancer. Upon completion of this activity, participants should be better able to: Summarize the recent safety and efficacy data on novel hormonal therapy for metastatic castration-sensitive prostate cancer (mCSPC), as well as for other prostate cancer settings including castration-resistant (nmCRPC and mCRPC) disease, Counsel patients on current hormonal therapy standards for personalized management of prostate cancer, including for treatment selection based on disease progression, prior therapy, and patient characteristics, Design individualized, evidence-based treatment plans for patients with prostate cancer, taking into consideration disease, treatment, and patient-specific factors, Manage the spectrum of adverse events associated with novel hormonal therapies in patients with prostate cancer.

Making the Case for Personalized Management in mCSPC: Pertinent Characteristics to Choose the Right Therapy

Making the Case for Personalized Management in mCSPC: Pertinent Characteristics to Choose the Right Therapy

Making the Case for Personalized Management in mCSPC: Pertinent Characteristics to Choose the Right Therapy

Making the Case for Personalized Management in mCSPC: Pertinent Characteristics to Choose the Right Therapy