Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK
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.
Authors
- Yiyun Tang (ORCID: https://orcid.org/0000-0001-9810-1288)
- Stephen J. Freedland (ORCID: https://orcid.org/0000-0002-8104-6419)
- M. Backhaus (ORCID: https://orcid.org/0000-0001-6214-784X)
- Antti Rannikko (ORCID: https://orcid.org/0000-0002-4261-3484)
- Arnauld Villers (ORCID: https://orcid.org/0000-0002-6298-7758)
- Ugo De Giorgi (ORCID: https://orcid.org/0000-0001-7520-2908)
- Jamal Tarazi (ORCID: https://orcid.org/0000-0002-5452-2061)
- Neal D. Shore (ORCID: https://orcid.org/0000-0001-5767-0548)
- Gabriel P. Haas
- Matt Rosales
Institutions
- Cedars-Sinai Medical Center (US)
- University of Helsinki (FI)
- Pfizer (United States) (US)
- Université de Lille (FR)
- Helsinki University Hospital (FI)
- Centre Hospitalier Universitaire de Lille (FR)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Fundación Instituto Valenciano de Oncología (ES)
- Durham VA Medical Center (US)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Hôpital Claude Huriez (FR)
- Carolina Urologic Research Center (US)
- Astellas Pharma (United States) (US)
Publication Details
- Journal
- Prostate Cancer and Prostatic Diseases
- Published
- 2025-03-26
- DOI
- https://doi.org/10.1038/s41391-025-00959-8
- Citations
- 2
- Primary Topic
- Prostate Cancer Treatment and Research
- Type
- article
- Field-Weighted Citation Impact
- 3.04
Funders
- Pfizer
- Astellas Pharma US