Subgroup Analysis Confirms Darolutamide Efficacy in Black Prostate Cancer Patients - Quoc-Dien Trinh
June 11, 2025
Zachary Klaassen interviews Quoc-Dien Trinh about Black patient representation in the ARANOTE trial. Dr. Trinh emphasizes the critical importance of studying minority subgroups in prostate cancer trials, noting that most studies include less than 5% Black patient representation despite their disproportionate disease burden. The ARANOTE trial randomized 669 patients with de novo metastatic hormone-sensitive prostate cancer to darolutamide plus ADT versus placebo plus ADT, showing significant benefits in radiographic progression-free survival, PSA suppression, and time to castration-resistant disease. In the Black patient subgroup analysis, darolutamide demonstrated similar efficacy and safety profiles compared to the overall population, with a hazard ratio of 0.51 for radiographic progression-free survival versus 0.54 in the general population. Dr. Trinh stresses that while this post-hoc analysis isn't powered for statistical significance, the data provide crucial reassurance to clinicians and patients that treatment intensification with darolutamide is both effective and safe for Black patients, addressing important disparities in access to optimal care.
Biographies:
Quoc-Dien Trinh, MD, MBA, Chair, Department of Urology, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA
Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor of Surgery/Urology at the Medical College of Georgia at Augusta University, Wellstar MCG, Georgia Cancer Center, Augusta, GA
Biographies:
Quoc-Dien Trinh, MD, MBA, Chair, Department of Urology, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA
Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor of Surgery/Urology at the Medical College of Georgia at Augusta University, Wellstar MCG, Georgia Cancer Center, Augusta, GA
Related Content:
AUA 2025: Efficacy and Safety of Darolutamide Plus ADT in Black Patients with mHSPC from the Phase 3 ARANOTE Trial
Racial Disparities in Prostate Cancer Active Surveillance Outcomes "Presentation" - Quoc-Dien Trinh
ESMO 2024 Quick Take Insights: A Focus on ARANOTE
ARANOTE Trial Implications for Metastatic Prostate Cancer Management, Journal Club - Rashid Sayyid & Zachary Klaassen
AUA 2025: Efficacy and Safety of Darolutamide Plus ADT in Black Patients with mHSPC from the Phase 3 ARANOTE Trial
Racial Disparities in Prostate Cancer Active Surveillance Outcomes "Presentation" - Quoc-Dien Trinh
ESMO 2024 Quick Take Insights: A Focus on ARANOTE
ARANOTE Trial Implications for Metastatic Prostate Cancer Management, Journal Club - Rashid Sayyid & Zachary Klaassen
Read the Full Video Transcript
Zachary Klaassen: Hi. My name is Zach Klaassen, Urologic Oncologist at the Georgia Cancer Center in Augusta, Georgia. We're at AUA 2025 in Las Vegas, and joined on UroToday by Doctor Quoc-Dien Trinh, who's a Chair of Urology, University of Pittsburgh. Quoc, thanks so much for joining us on your show today.
Quoc-Dien Trinh: Thanks, Zach. Thanks for having me.
Zachary Klaassen: So ARANOTE had a huge splash. We had the big results presented at ESMO 2024. Before we get into the subgroup analysis, looking at the Black patients in ARANOTE. Just maybe set the stage for what the ITT population data showed us.
Quoc-Dien Trinh: Yeah, absolutely. So ARANOTE, very important study, obviously. 669 patients across 15 countries. We're looking, really, at the space of de novo metastatic hormone-sensitive prostate cancer. And what they did was a two to one randomization of darolutamide plus ADT, versus ADT plus placebo. And the study findings were very, very compelling. We saw that there was a benefit with regards to the primary endpoint of radiographic progression-free survival.
We also saw clear evidence that the rate of PSA suppression was significantly higher in the darolutamide group. We saw a benefit with regards to time to castrate resistant prostate cancer, and also some data with regards to overall survival.
Zachary Klaassen: Absolutely. And just looking at the Black subgroup population, I know ARASENS, which was the triplet therapy with darolutamide and docetaxel, versus placebo docetaxel and ADT. When we look at the subgroup in that setting, it's important, because we see about 54 patients had a benefit with the triple therapy as well. Why would you say it's important in these types of studies to look at these important minority subgroups?
Quoc-Dien Trinh: As you know, it's a very important topic, and it's something that I've focused a lot in many years. We know that there's an under-representation of certain populations in clinical trials. And that's true at large, but it's especially true in prostate cancer. If you look at this specific space, most trials have less than 5% of Black population representation. If you look at some of these studies, there's actually not even a discussion about race-specific data.
And it's very hard, because we know the data on African-American men, and incidence and mortality of prostate cancer. And we want to know if these drugs work for the African-American population, and we want clinicians to be reassured that treatment intensification works for that population. And then the patients-- the patients want to know if this is something that is good for them.
Zachary Klaassen: Yeah, and what you just summarized is perfect. We need to put into trials who we're going to be treating in the real world. And that's exactly what we need to get to from the outset for these big trials, but also these important subgroups. So maybe just walk through the key findings from this subgroup you presented for ARANOTE.
Quoc-Dien Trinh: Yeah, the take home message really here is that in the African and in the Black population, the data suggests that there's efficacy and there's safety. So if you look at the primary endpoint of radiographic progression-free survival, the hazard ratio was 0.51, which compares pretty well to the hazard ratio of 0.54 in the general population. If you look at time to castrate resistant prostate cancer, you find similar findings with a very compelling benefit that looks obviously, not statistically significantly, but slightly even better than the general population.
And with regards to safety, what we found is a safety profile-- a side effect profile that is pretty similar to the general population, and that includes discontinuation to treatments. There was no significant difference between the two.
Zachary Klaassen: Yeah. Great summary of the findings. When I think about these post-hoc analyses, obviously not powered to show differences. So from that standpoint, taking that into context. But it's important for our discussions with these patients. So based on this data, how can we sit down with an African-American patient who's considering treatment intensification with darolutamide?
Quoc-Dien Trinh: Yeah, it's super, super important. Because again, going back to what I said earlier, certain populations are potentially less likely to get the most up-to-date treatment, or treatment intensification. I think there's pretty good real world data about that. And what these data show is that treatment intensification, darolutamide plus ADT in this population works. It's a good treatment, and it's also safe.
And I think that is the message that we want clinicians to take home. That's the message that we want patients to know as they embark on this journey, and try to figure out what's best for them.
Zachary Klaassen: Absolutely. Great conversation on ARANOTE. It's a great trial, and this disease space is exciting. And we appreciate your time on UroToday, looking at the Black population in this trial.
Quoc-Dien Trinh: Hey, thanks Zach.
Zachary Klaassen: Hi. My name is Zach Klaassen, Urologic Oncologist at the Georgia Cancer Center in Augusta, Georgia. We're at AUA 2025 in Las Vegas, and joined on UroToday by Doctor Quoc-Dien Trinh, who's a Chair of Urology, University of Pittsburgh. Quoc, thanks so much for joining us on your show today.
Quoc-Dien Trinh: Thanks, Zach. Thanks for having me.
Zachary Klaassen: So ARANOTE had a huge splash. We had the big results presented at ESMO 2024. Before we get into the subgroup analysis, looking at the Black patients in ARANOTE. Just maybe set the stage for what the ITT population data showed us.
Quoc-Dien Trinh: Yeah, absolutely. So ARANOTE, very important study, obviously. 669 patients across 15 countries. We're looking, really, at the space of de novo metastatic hormone-sensitive prostate cancer. And what they did was a two to one randomization of darolutamide plus ADT, versus ADT plus placebo. And the study findings were very, very compelling. We saw that there was a benefit with regards to the primary endpoint of radiographic progression-free survival.
We also saw clear evidence that the rate of PSA suppression was significantly higher in the darolutamide group. We saw a benefit with regards to time to castrate resistant prostate cancer, and also some data with regards to overall survival.
Zachary Klaassen: Absolutely. And just looking at the Black subgroup population, I know ARASENS, which was the triplet therapy with darolutamide and docetaxel, versus placebo docetaxel and ADT. When we look at the subgroup in that setting, it's important, because we see about 54 patients had a benefit with the triple therapy as well. Why would you say it's important in these types of studies to look at these important minority subgroups?
Quoc-Dien Trinh: As you know, it's a very important topic, and it's something that I've focused a lot in many years. We know that there's an under-representation of certain populations in clinical trials. And that's true at large, but it's especially true in prostate cancer. If you look at this specific space, most trials have less than 5% of Black population representation. If you look at some of these studies, there's actually not even a discussion about race-specific data.
And it's very hard, because we know the data on African-American men, and incidence and mortality of prostate cancer. And we want to know if these drugs work for the African-American population, and we want clinicians to be reassured that treatment intensification works for that population. And then the patients-- the patients want to know if this is something that is good for them.
Zachary Klaassen: Yeah, and what you just summarized is perfect. We need to put into trials who we're going to be treating in the real world. And that's exactly what we need to get to from the outset for these big trials, but also these important subgroups. So maybe just walk through the key findings from this subgroup you presented for ARANOTE.
Quoc-Dien Trinh: Yeah, the take home message really here is that in the African and in the Black population, the data suggests that there's efficacy and there's safety. So if you look at the primary endpoint of radiographic progression-free survival, the hazard ratio was 0.51, which compares pretty well to the hazard ratio of 0.54 in the general population. If you look at time to castrate resistant prostate cancer, you find similar findings with a very compelling benefit that looks obviously, not statistically significantly, but slightly even better than the general population.
And with regards to safety, what we found is a safety profile-- a side effect profile that is pretty similar to the general population, and that includes discontinuation to treatments. There was no significant difference between the two.
Zachary Klaassen: Yeah. Great summary of the findings. When I think about these post-hoc analyses, obviously not powered to show differences. So from that standpoint, taking that into context. But it's important for our discussions with these patients. So based on this data, how can we sit down with an African-American patient who's considering treatment intensification with darolutamide?
Quoc-Dien Trinh: Yeah, it's super, super important. Because again, going back to what I said earlier, certain populations are potentially less likely to get the most up-to-date treatment, or treatment intensification. I think there's pretty good real world data about that. And what these data show is that treatment intensification, darolutamide plus ADT in this population works. It's a good treatment, and it's also safe.
And I think that is the message that we want clinicians to take home. That's the message that we want patients to know as they embark on this journey, and try to figure out what's best for them.
Zachary Klaassen: Absolutely. Great conversation on ARANOTE. It's a great trial, and this disease space is exciting. And we appreciate your time on UroToday, looking at the Black population in this trial.
Quoc-Dien Trinh: Hey, thanks Zach.