This is the second approved indication in
The approval is based on results from the PROSPER trial, a double-blind, placebo-controlled, pivotal Phase 3 trial that evaluated enzalutamide plus ADT versus placebo plus ADT in 1,401 men with nmCRPC and rapidly rising prostate-specific antigen levels. PROSPER met its primary endpoint of metastasis-free survival (MFS), with a median MFS of 36.6 months for men who received enzalutamide plus ADT, compared to 14.7 months with placebo plus ADT. Results demonstrated a 71 percent reduction in the risk of radiographic progression or death in men who received enzalutamide plus ADT, compared to placebo plus ADT (hazard ratio=0.29 [95% confidence interval: 0.24-0.35]; p
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