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.
Prostate cancer and prostatic diseases. 2026 Jun 20 [Epub ahead of print]
Quoc-Dien Trinh, Daniel J George, Neal Shore, Egils Vjaters, David Olmos, Andrea Juliana P de Santana Gomes, Augusto Cesar de Andrade Mota, Natasha Littleton, Shankar Srinivasan, Frank Verholen, Kunhi Parambath Haresh, Fred Saad
University of Pittsburgh Medical Center, Pittsburgh, PA, USA. ., Duke University School of Medicine, Duke Cancer Institute, Durham, NC, USA., Carolina Urologic Research Center and AUC Urology Specialists, Myrtle Beach, SC, USA., P. Stradinš Clinical University Hospital, Riga, Latvia., Department of Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (Imas12), Madrid, Spain., Liga Norte Riograndense Contra O Cancer, Natal, Brazil., Medical Oncology, Instituto ETICA - Clinica AMO/DASA, Salvador, Brazil., Bayer Ltd, Dublin, Ireland., Bayer Healthcare, Whippany, NJ, USA., Bayer Consumer Care AG, Basel, Switzerland., All India Institute of Medical Sciences, New Delhi, India., University of Montreal Hospital Centre, Montreal, QC, Canada.