Fizazi K, et al. - In a double-blind, placebo-controlled phase 3 trial (the ARAMIS trial), researchers tested darolutamide, a structurally unique androgen receptor (AR) antagonist, in terms of efficacy and safety in nmCRPC patients. Participants included 1,509 patients who were given darolutamide 600 mg (two 300 mg tablets) twice-daily (n=955) or placebo (n=554) while continuing androgen deprivation therapy. Taking into account prostate-specific antigen doubling time (≤6 months or >6 months) and use of osteoclast-targeted therapy, stratification of patients was done. Darolutamide vs placebo offered a median metastasis-free survival (MFS) of 40.4 months vs 18.4 months, respectively. Darolutamide was also favored by the observed overall survival (OS) trend. Overall, in an asymptomatic population of men with nmCRPC, treatment with darolutamide vs placebo was associated with significantly longer MFS and a low incidence of treatment-related adverse events.