Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial | Journal of Clinical Oncology
Purpose For patients with metastatic hormone-sensitive prostate cancer (mHSPC), delaying progression to castration-resistant disease is important not only for overall survival (OS) but also for patients’ quality of life . Darolutamide plus androgen-deprivation therapy (ADT) with docetaxel improved OS versus ADT and docetaxel in patients with mHSPC. The ARANOTE trial evaluated darolutamide and ADT without chemotherapy in patients with mHSPC. Methods In this global phase 3 trial, patients were randomized 2:1 to receive darolutamide 600 mg twice daily or placebo, with concomitant ADT. The primary endpoint was radiological progression-free survival (rPFS). Results From March 2021 to August 2022, 669 patients were randomized (darolutamide n=446; placebo n=223). At the primary cutoff date (June 7, 2024), darolutamide plus ADT significantly improved rPFS by 46% versus placebo plus ADT (hazard ratio [HR] 0.54; 95% confidence interval [CI], 0.41–0.71; P<0.0001), with consistent benefits across
