High-risk biochemical recurrence (BCR) definition varies across clinical studies/practice guidelines. We evaluated metastasis-free survival (MFS) by blinded, independent, central review and safety in EMBARK (NCT02319837) patients defined as high-risk BCR per European Association of Urology (EAU) criteria. Patients post-radical prostatectomy (prostatic-specific antigen doubling time ≤9 months) or post-radiation therapy with a Gleason score > 7, were considered EAU high-risk. MFS improved with enzalutamide + leuprolide (HR 0.37, 95% CI 0.25‒0.57) and enzalutamide monotherapy (HR 0.57, 95% CI 0.39‒0.83) versus leuprolide alone. MFS and safety for enzalutamide ± leuprolide versus leuprolide alone were similar in EMBARK patients with EAU-consistent or protocol-defined high-risk BCR. Clinical trial registration number: NCT02319837.
Prostate cancer and prostatic diseases. 2025 Mar 26 [Epub ahead of print]
Ugo De Giorgi, Stephen J Freedland, Antti Rannikko, Miguel Ramirez-Backhaus, Arnauld Villers, Jamal Tarazi, Yiyun Tang, Gabriel P Haas, Matt Rosales, Neal D Shore
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy., Department of Urology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Department of Urology and Research Program in Systems Oncology, University of Helsinki, Helsinki, Finland., Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, Spain., Department of Urology, Claude Huriez Hospital, CHU Lille, University of Lille, Lille, France., Global Product Development, Pfizer Inc., La Jolla, CA, USA., Pfizer Inc., South San Francisco, CA, USA., Global Product Development, Astellas Pharma Inc., Northbrook, IL, USA., Carolina Urologic Research Center, Myrtle Beach, SC, USA. .