OncoMatch/Clinical Trials/NCT05766371
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
Is NCT05766371 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and 177Lu-PSMA-617 for castrate resistant prostate cancer.
Treatment: Pembrolizumab · 177Lu-PSMA-617 — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) psma pet avid lesion (uptake above background liver)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: second generation androgen signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Cannot have received: psma-directed therapy
Cannot have received: anti-pd-1/pd-l1/pd-l2 or co-inhibitory t-cell receptor therapy
Cannot have received: taxane-based chemotherapy
Exception: ≤2 lines allowed
Cannot have received: external beam radiation involving >25% of bone marrow
Lab requirements
Blood counts
anc ≥1,500/mcl; platelets ≥100,000/mcl; hemoglobin > 9.0 g/dl
Kidney function
creatinine ≤ 1.5 x uln or creatinine clearance (gfr) ≥ 50 ml/min/1.73 m^2
Liver function
total bilirubin ≤ 1.5 x uln (direct bilirubin ≤ uln if gilbert's); ast/alt ≤ 2.5 x uln (≤ 5 x uln with liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05766371 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior psma-directed therapy, anti-pd-1/pd-l1/pd-l2 or co-inhibitory t-cell receptor therapy, taxane-based chemotherapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 psma pet avid lesion is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify