Efficacy and safety of darolutamide plus androgen-deprivation therapy in Black patients with metastatic hormone-sensitive prostate cancer from the phase 3 ARANOTE trial

This analysis reports efficacy and safety data in the subgroup of Black patients from the ARANOTE phase 3 trial. Patients starting on androgen-deprivation therapy (ADT) were randomised 2:1 to receive darolutamide 600 mg twice daily or placebo. Of the total ARANOTE population ( N = 669), 65 patients (10%; darolutamide, n = 41; placebo, n = 24) were Black. In Black patients, darolutamide + ADT improved radiological progression-free survival (rPFS), reducing the risk of radiological progression or death by 49% vs ADT alone, consistent with the overall population. In Black patients from ARANOTE, darolutamide was associated with improvement in rPFS.