Multicenter randomized phase 2 trial of darolutamide maintenance after successful taxane chemotherapy for mCRPC

The multicenter randomized phase 2 SAKK 08/16 trial evaluated darolutamide maintenance therapy in patients with metastatic castration-resistant prostate cancer who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane. Darolutamide maintenance resulted in statiscally significant but clinically modest prolongation of the radiographic progession-free survival, event-free survival, and 50% PSA response rate, with good tolerability.