ARCHES — Enzalutamide Plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer (ARCHES)

Phase 3 · 2019 · Prostate Cancer

Design

Randomized double-blind trial of enzalutamide plus ADT versus placebo plus ADT.

Population

Metastatic hormone-sensitive prostate cancer, including patients with prior docetaxel.

Primary Endpoint

radiographic progression-free survival (rPFS)

Key Result

5-year analysis (median 61.4 mo): 5-yr OS 66% vs 53% (HR 0.70; medians not reached); rPFS HR 0.39 in the primary analysis.

Guideline Impact

NCCN category 1 enzalutamide plus ADT for metastatic castration-sensitive prostate cancer