Phase III Study Comparing AZD2265 Versus Standard Treatments for PSMA-positive Metastatic Castration-resistant Prostate Cancer

What this Trial Is About

This research aims to evaluate the superiority of AZD2265 compared to standard care treatments in adult men with PSMA-positive metastatic castration-resistant prostate cancer mCRPC. The study focuses on measuring radiographic progression-free survival and overall survival to understand how well AZD2265 performs against existing therapies. Approximately 670 participants will be involved in this phase III randomized controlled trial sponsored by AstraZeneca. Participants will be randomly assigned to receive either AZD2265 or one of the standard care treatments chosen by the investigator, which may include cabazitaxel chemotherapy, switching androgen receptor pathway inhibitors ARPIs, or radium-223 therapy. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. Tumor scans will be conducted during and after treatment to monitor disease status. Throughout the study, participants will undergo tumor evaluation scans regularly to detect progression or response. They will be followed for survival until the study ends in 2029. Safety and scientific integrity will be overseen by an independent committee. Researchers will assess various outcomes, including progression-free survival, PSA reductions, response rates, and bone event-free survival, with plasma levels of AZD2265 monitored during early treatment cycles.

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)