Phase II Study of Enhertu for HER2-Positive Metastatic Castration-Resistant Prostate Cancer After Hormonal Therapy

What this Trial Is About

Researchers are evaluating the use of Enhertu as a treatment for men with HER2-positive metastatic castration-resistant prostate cancer mCRPC who have not responded to prior androgen deprivation therapy and novel hormonal agents. This Phase II trial focuses on patients who are either not candidates for or have declined taxane-based chemotherapy. The study is led by Dr. Maneesh Jain at the Washington DC VA and aims to assess both the effectiveness and safety of Enhertu. Participants will receive Enhertu as a single-arm treatment in an open-label, multi-center setting. The study will include 60 men who meet the criteria and will monitor the drugs anti-tumor activity and safety profile. The treatment involves ongoing androgen deprivation therapy to maintain low testosterone levels, and patients must provide tumor tissue samples for HER2 testing. During the study, participants will be regularly assessed for tumor response, progression-free survival, overall survival, and quality of life over a two-year period. Researchers will monitor heart function, blood clotting, organ health, and other safety parameters. The study involves continuous evaluation to measure the duration and control of disease response while ensuring participant safety throughout the trial period.

Castrate Resistant Prostate Cancer Enhertu Therapy