The New England Journal of MedicineDarolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer

The study included 1,306 patients (darolutamide: 651, placebo: 655), with 86.1% having metastatic disease at the time of diagnosis. At the primary analysis’s data cutoff date (October 25, 2021), the risk of death in the darolutamide group was 32.5% lower than in the placebo group. Adverse events were comparable in both groups, and the most common adverse events (occurring in 10% of patients) were most common during the overlapping docetaxel treatment period in both groups.