Wednesday, January 06, 2021 PR21 A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease has been centrally activated. Investigating a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617 can slow the growth of prostate cancer compared to standard chemotherapy treatment. Objectives: (Primary): To compare radiographic progression-free survival (rPFS) of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA radioligand therapy vs. docetaxel in the post androgen receptor (AR)-targeted therapy setting. (Secondary): Second rPFS in patients who meet criteria for rPFS and crossover to the alternate therapy (Secondary):Time to commencement of third line therapy (Secondary): Overall survival (Secondary):proportion of patients with decreased PSA from baseline and the magnitude of change (Secondary):Clinical benefit rate (CBR) and response duration including partial response (PR), complete response (CR) or stable disease > 24 weeks (Secondary): Determine adverse event (AE) profile (Secondary): Patient reported QOL (Secondary): Cost-effectiveness (Tertiary): explore biomarkers of response and resistance using cell free DNA (Tertiary): retrospectively explore a dosimetry-based approach to determine administered activity. For more information please visit the CCTG PR21 Trial page
