Phase 1 Study of PRL-02 Depot Injection with or without Enzalutamide for Men with Advanced Prostate Cancer

What this Trial Is About

Researchers are studying PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer, including those whose cancer has returned or not responded to previous treatments. The trial aims to evaluate the safety and tolerability of PRL-02 depot alone or combined with enzalutamide, as well as to determine the appropriate dose. This Phase 1 study is sponsored by Astellas Pharma Global Development, Inc. and focuses on men with metastatic or biochemical relapse forms of prostate cancer. Participants will be divided into groups receiving different doses of PRL-02 depot injected into a muscle every 12 weeks. They will also take daily oral doses of either dexamethasone, prednisone, or enzalutamide depending on their study group and prior treatments. The study has two parts dose escalation with small groups receiving increasing doses, and dose expansion involving men previously treated with specific hormone therapies. During the trial, men will visit the clinic multiple times for health checks, scans, and blood tests to monitor side effects, disease progression, and testosterone suppression. After the final visit, those whose cancer has not worsened will continue to have periodic health assessments and scans. The main outcomes include tracking dose limiting toxicities and adverse events over up to four years, along with detailed pharmacokinetic and response measurements.

A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer