A phase 2 trial of ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a AR targeting agent and non-progressive on a second line taxane (SAKK 08/16).

TPS393Background: Treatment with the AR targeting agents abirateroneor enzalutamidefollowed by a taxaneis currently the most used treatment for men with mCRPC. Further treatment after response to chemotherapy is only indicated in case of disease progression, with limited treatment options available. ODM-201 ( Darolutamide) is a second-generation oral androgen receptorantagonist which has demonstrated a good safety profile and antitumor activity in mCRPC. This trial evaluates whether the immediate use of darolutamideafter successful chemotherapy can prolong radiographic progression-free survival(rPFS) compared with watchful waitingin patients with mCRPC. Methods: This is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial (NCT02933801) conducted in approximately 19 sites in Switzerland and Italy. Patients with mCRPC are required to have been previously treated with abirateroneor enzalutamideand have no evidence of disease progression on docetaxel or cabazitaxel. Patients (N = ...