EMBARK — Enzalutamide With or Without Leuprolide in High-Risk Biochemically Recurrent Nonmetastatic Hormone-Sensitive Prostate Cancer

Phase 3 · 2023 · Prostate Cancer

Design

Randomized phase 3 to enzalutamide + leuprolide, enzalutamide monotherapy, or leuprolide alone.

Population

High-risk biochemically recurrent nonmetastatic hormone-sensitive prostate cancer with a short PSA doubling time after definitive local therapy.

Primary Endpoint

metastasis-free survival (MFS)

Key Result

5-yr MFS 87.3% with enzalutamide + leuprolide vs 71.4% with leuprolide alone (HR 0.42); enzalutamide monotherapy also improved MFS.

Guideline Impact

High-risk biochemically recurrent prostate cancer