Kelly L. Stratton, MD, FACS, discusses the OS gains seen with enzalutamide plus ADT in EMBARK

In this video, recorded at the 2025 Society of Urologic Oncology Annual Meeting in Phoenix, Arizona, Kelly L. Stratton, MD, FACS, deemed the of the EMBARK trial results from the European Society for Medical Oncology Congress as one of the most significant advancements in prostate cancer care. This trial focused on men with high-risk biochemical recurrence after definitive local therapy—either prostatectomy or radiation—who had no detectable metastases but were experiencing a rising prostate-specific antigen (PSA) level. These patients often face considerable anxiety because PSA levels should remain undetectable or very low after treatment, making biochemical recurrence an especially challenging clinical stage.

The EMBARK trial randomized patients into three groups: Enzalutamide (Xtandi) plus leuprolide, enzalutamide alone, or standard observation with leuprolide alone. Importantly, the study included men whose PSA was rising rapidly—doubling in less than 9 months. Eligibility thresholds differed based on prior treatment: PSA greater than 1 ng/mL after prostatectomy or greater than 2 ng/mL after radiation. Patients received 9 months of therapy, and if their PSA level fell below 0.2 ng/mL, treatment was stopped, offering the possibility of a medication “holiday.”

The key finding was a clear overall survival benefit for patients treated with the combination of enzalutamide and leuprolide. This outcome marks a major shift in managing high-risk biochemical recurrence, moving away from older strategies such as intermittent androgen deprivation therapy. The finite treatment duration, along with physicians’ existing familiarity with both medications, has made adoption of the new regimen smooth in clinical practice.

Stratton emphasized that the trial’s results provide greater confidence in recommending therapy and allow clinicians to counsel patients more decisively about next steps when PSA begins to rise. The approach gives patients both a structured treatment plan and the reassurance that early intervention can improve survival. Overall, he said he sees the EMBARK trial as a transformative development in 2025, offering meaningful improvements in how recurrent prostate cancer is treated and monitored.

REFERENCE

1. Shore ND, de Almeida Luz M, De Giorgi U, et al. Overall survival with enzalutamide in biochemically recurrent prostate cancer. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract LBA87