Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK
Year: 2025
Type: article
Abstract: 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.
Institutions: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Cedars-Sinai Medical Center, Durham VA Medical Center, University of Helsinki, Helsinki University Hospital, Fundación Instituto Valenciano de Oncología, Université de Lille, Hôpital Claude Huriez, Pfizer (United States), Astellas Pharma (United States), Carolina Urologic Research Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,190
Funders: Pfizer, Astellas Pharma US
OpenAlex ID: W4408876797