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