Phase 3, randomized, international trial (EMBARK))
Adult patients with prostate cancer who had biochemical recurrence after local therapy and meet the following criteria at screening: high-risk disease (defined as a PSA doubling time of ≤9 months and a PSA level of ≥2 ng per milliliter above nadir after RT or ≥1 ng per milliliter after surgery)
Enzalutamide + ADT(n=355) vs. ADT monotherapy (n=358) vs. Enzalutamide monotherapy (n=355)
Efficacy
5-year metastasis-free survival: 87.3% vs. 71.4% vs. 80%, HR:0.42, p<0.001
5-year OS: 92.2% vs. 87.2% vs. 89.2%, HR: 0.59, p=0.020
Safety
Grade3: Fatigue (3.4% vs. 1.4% vs. 4.0%), hematuria (2.0% vs. 0.8% vs. 1.7%)
