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A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

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Trial Profile

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2025

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At a glance

  • Drugs Enzalutamide (Primary) ; Leuprorelin (Primary) ; Leuprorelin (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBARK
  • Sponsors Medivation; Pfizer

Most Recent Events

  • 10 Jul 2025 Results presented in the Astellas Pharma Media Release.
  • 19 May 2025 According to a Astellas Pharma media release, data from this trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3).
  • 23 Apr 2024 According to an Astellas Pharma media release, announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy based on results from the Phase 3 EMBARK trial.

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