Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
Trial Parameters
Brief Summary
This is a single-center, open-label, study of Prostate-Specific Membrane Antigen (PSMA)-targeted radionuclide therapy with 177Lu-PSMA-617 in combination with pembrolizumab in participants with metastatic castrate-resistant prostate cancer (mCRPC) who have previously progressed on at least one prior androgen pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide).
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed prostate adenocarcinoma that is progressive metastatic castration-resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria at the time of study entry. 2. Male participants who are at least 18 years of age on the day of signing informed consent. 3. Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study. 4. Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide. 5. Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade \<= 1 (except for any grade alopecia and grade \<= 2 neuropathy). 6. Prior radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from st