Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Official Title

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


The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiation therapy or both.

Trial Description

Primary Outcome:

  • Metastasis-free survival (MFS)
Secondary Outcome:
  • Overall survival
  • Proportion of patients per group who remain treatment-free 2 years after suspension of study drug treatment at week 37 due to undetectable Prostate-Specific Antigen (PSA).
  • Time to castration resistance
  • Prostate cancer-specific survival
  • Time to first symptomatic skeletal event
  • Composite of safety

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society