AUANews Inside Tract American Urological Association

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.

Dr. Andrew Lai, a University of Illinois College of Medicine Co-Chief Resident and author of the AUANews article, “My Journey as an Out and Proud Urology Resident,” talks with his fellow Co-Chief Resident Dr. Rabun Jones about the challenges they have faced being gay and bi-sexual throughout their residency, and the importance of representation as they prepare to graduate this year. 

Today’s podcast episode is part of the “Voices” series and is brought to you by the Diversity, Equity & Inclusion Committee. Join Dr. Larissa Bresler, Professor of urology, obstetrics and gynecology at the Loyola University Medical Center, Dr. Randy Vince, Director of Minority Men’s Health at the Cutler Center for Men at University Hospitals, Assistant Professor of urology at Case Western Reserve University in Cleveland, Ohio and the AUA’s 2023 Health Equity Fellow, as well as Dr. Chuck Scales, Associate Dean for Clinical Research Initiatives and Associate Professor at Duke University Health System as they discuss HealthEMe, their new endeavor developing health outcome metrics for our minority patients.

Today’s podcast episode is part of the “Voices” series and is brought to you by the Diversity, Equity & Inclusion Committee. Join Dr. Raju Thomas, former president of the AUA and the Departmental Chair and Professor of Urology at Tulane University School of Medicine, and Nader Shayegh, a medical student at the Howard University College of Medicine, as they talk about our experience as a mentor/mentee pair for the FUTURE Program at the Annual Urology Advocacy Summit in Washington, D.C.

This episode of JU Insights on the Go contains JU Insights of articles published in the January 2024 issue of The Journal of Urology®.

Welcome to the AUANews Inside Tract Podcast! In this episode, Dr. Rosalyn Adam, a cell biologist and biochemist with over 20 years of experience in studies related to fundamental mechanisms of urologic disease at Boston Children’s Hospital and Harvard Medical School, talks with Dr. Kristian Stensland, a urologic oncologist and health services researcher at the University of Michigan and the VA Ann Arbor Healthcare System, about the AUA’s most recent Early-Career Investigator Workshop (ECIW). Dr. Adam served as Dr. Stensland’s mentor as Dr. Stensland navigated the labyrinth of grant writing during ECIW.