Maha H. Hussain, MD, FACP, FASCO, presents “Darolutamide Plus Androgen-Deprivation Therapy in Patients with Metastatic Hormone-Sensitive Prostate Cancer: Efficacy and Safety by Disease Volume in the Phase 3 ARANOTE Study”
How to cite: Hussain, Maha H. “Darolutamide Plus Androgen-Deprivation Therapy in Patients with Metastatic Hormone-Sensitive Prostate Cancer: Efficacy and Safety by Disease Volume in the Phase 3 ARANOTE Study” February 19, 2025. Accessed Feb 2026. https://grandroundsinurology.com/darolutamide-plus-androgen-deprivation-therapy-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-efficacy-and-safety-by-disease-volume-in-the-phase-3-aranote
Darolutamide Plus Androgen-Deprivation Therapy in Patients with Metastatic Hormone-Sensitive Prostate Cancer: Efficacy and Safety by Disease Volume in the Phase 3 ARANOTE Study – Summary
E. David Crawford, MD, Editor of Grand Rounds in Urology and Professor of Urology at the University of California, San Diego, introduces Maha H. Hussain, MD, FACP, FASCO, Professor of Medicine and Deputy Director, Northwestern University – The Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Evanston, Illinois. In this 9-minute talk, Dr. Crawford and Dr. Hussain discuss the recent FDA approval of darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT), with or without docetaxel, based on results from the phase III ARANOTE trial.
This approval represents a significant advancement in the treatment of metastatic castration-sensitive prostate cancer (mCSPC). Dr. Hussain underscores the importance of expanding therapeutic options to personalize treatment based on patient-specific factors such as age, comorbidities, and disease characteristics. She traces the evolution of therapy from first-generation antiandrogens to third-generation AR pathway inhibitors.
The conversation moves to triplet therapy—ADT, docetaxel, and an AR inhibitor—which may benefit younger, fitter patients with de novo high-volume disease. In contrast, doublet therapy remains appropriate for others.
Darolutamide is noted for a favorable safety profile and fewer drug interactions, which may simplify clinical decision-making. Dr. Hussain emphasizes the critical balance between therapeutic benefit and toxicity. Both agree that patient preferences and quality of life must guide care.
