Actively Recruiting
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
Led by University of California, San Francisco · Updated on 2026-04-17
48
Participants Needed
1
Research Sites
389 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic castration-resistant prostate cancer progressing per PCWG3 criteria
- Male participants aged 18 years or older
- Castrate serum testosterone level below 50 ng/dL; if no bilateral orchiectomy, must continue LHRH analogue treatment
- Prior progression on at least one second-generation androgen signaling inhibitor (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
- Recovery to Grade �3=1 for prior anti-cancer treatment side effects (except alopecia and Grade �2 neuropathy)
- Prior radiotherapy allowed if last treatment was over 2 weeks before study start and patient has recovered with no corticosteroid need or pneumonitis
- At least one PSMA PET avid lesion with uptake above liver background
- ECOG performance status of 0 or 1 (Karnofsky �3= 70%)
- Adequate bone marrow, liver, and kidney function as specified
- Use of effective contraception during treatment and for 6 months after
- Consent to follow radioprotection precautions
- Willingness to undergo tumor biopsy if accessible
- Previously treated brain metastases allowed if treatment was over 28 days ago, no new lesions on MRI, and stable without steroids
- Prior or concurrent malignancies allowed if not interfering with study
- Ability and willingness to sign informed consent
You will not qualify if you...
- De novo small cell neuroendocrine prostate cancer
- Soft tissue lesions larger than specified that are negative on PSMA PET
- Systemic anti-cancer therapy within 14 days before study start (except LHRH analogues)
- Untreated brain metastases
- Prior PSMA-directed treatment
- Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Participation in other investigational studies within 4 weeks before study start
- More than 2 prior lines of taxane chemotherapy
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within 2 years
- Diagnosis of immunodeficiency or recent immunosuppressive therapy
- History of significant pneumonitis or interstitial lung disease
- Receipt of live vaccine within 30 days before study start
- Inability to give valid informed consent due to age, medical, or psychiatric conditions
- Significant cardiovascular disease as detailed
- Recent major surgery or radiation involving large bone marrow area
- Active infection requiring IV antibiotics
- Active or untreated Hepatitis B or C infections except controlled cases
- Active tuberculosis
- Psychiatric or substance abuse disorders interfering with study participation
- Bleeding disorders that prevent safe biopsy
- Any condition impairing ability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Genitourinary Medical Oncology Recruitment
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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