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June 22, 2026Open Access

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

Key Points

This analysis aims to evaluate the efficacy and safety of darolutamide plus androgen-deprivation therapy in Black patients with metastatic hormone-sensitive prostate cancer.
Subgroup analysis of Black patients from the ARANOTE phase 3 trial with N=669 total participants.
Patients were randomized 2:1 to receive darolutamide 600 mg twice daily or placebo alongside androgen-deprivation therapy.
The subgroup consisted of 65 Black patients, with 41 receiving darolutamide and 24 receiving placebo.
Darolutamide plus ADT reduced the risk of radiological progression or death by 49% compared to ADT alone in Black patients.
Improvement in radiological progression-free survival in Black patients aligns with findings from the overall ARANOTE trial population.

Abstract

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.

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