177Lu-PSMA-617 + Pembrolizumab for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase Ib trial studies the dose and schedule of 177Lu-PSMA-617 and pembrolizumab in treating persons with castration-resistant prostate cancer that has spread to other places in the body. 177Lu-PSMA-617 carries a radioactive component which attached to the prostate specific membrane antigen (PSMA) receptor found on tumor cells. Its radiation component destroys the tumor cell. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving 177Lu-PSMA-617 and pembrolizumab may work better at treating prostate cancer.
Research Team
Rahul Aggarwal, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for patients with metastatic castration-resistant prostate cancer who've progressed after treatment with androgen signaling inhibitors. They must have good blood counts, organ function, agree to contraception, and not have untreated brain metastases or certain other health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lutetium Lu 177-PSMA-617 and pembrolizumab according to one of three dosing schedules. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years).
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Extension
Participants who achieve stable disease or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Treatment Details
Interventions
- Lutetium Lu 177-PSMA-617
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Prostate Cancer Foundation
Collaborator
National Cancer Institute (NCI)
Collaborator