NCT05766371

Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer

Recruiting now Phase 2 Last updated 17 April 2026

What this trial tests

Phase 2 trial testing Pembrolizumab in Castrate Resistant Prostate Cancer in 48 participants. Currently enrolling.

Timeline

15 December 2023

Primary endpoint
31 May 2027

31 May 2031

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	15 December 2023
Primary completion	31 May 2027
Estimated completion	31 May 2031
Sites	1 location across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• 177Lu-PSMA-617 — full drug profile →

Conditions studied

• Castrate Resistant Prostate Cancer — all drugs for Castrate Resistant Prostate Cancer →
• Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →
• Prostate Carcinoma — all drugs for Prostate Carcinoma →

Sponsor

University of California, San Francisco

Who can join

18 and older, male only, with Castrate Resistant Prostate Cancer or Metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Single-dose <sup>177</sup>Lu-PSMA-617 followed by maintenance pembrolizumab in patients with metastatic castration-resistant prostate cancer: an open-label, dose-expansion, phase 1 trial.
   Aggarwal R, Starzinski S, de Kouchkovsky I, Koshkin V, et al · · 2023 · cited 63× · PMID 37922930 · DOI 10.1016/s1470-2045(23)00451-5
2. Emerging Immunotherapy Approaches for Treating Prostate Cancer.
   Meng L, Yang Y, Mortazavi A, Zhang J. · · 2023 · cited 25× · PMID 37762648 · DOI 10.3390/ijms241814347
3. Intensification Approaches and Treatment Sequencing in Metastatic Castration-resistant Prostate Cancer: A Systematic Review.
   Francini E, Agarwal N, Castro E, Cheng HH, et al · · 2025 · cited 21× · PMID 39306478 · DOI 10.1016/j.eururo.2024.09.008
4. Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey.
   McManus HD, Dorff T, Morgans AK, Sartor O, et al · · 2025 · cited 14× · PMID 39420184 · DOI 10.1038/s41391-024-00906-z
5. Current clinical application of lutetium‑177 in solid tumors (Review).
   Niu T, Fan M, Lin B, Gao F, et al · · 2024 · cited 13× · PMID 38596660 · DOI 10.3892/etm.2024.12514
6. Prostate-Specific Membrane Antigen-Targeted Therapy in Prostate Cancer: History, Combination Therapies, Trials, and Future Perspective.
   Mattana F, Muraglia L, Barone A, Colandrea M, et al · · 2024 · cited 9× · PMID 38730595 · DOI 10.3390/cancers16091643
7. Efficacy of combined targeted radionuclide therapy and immune checkpoint Inhibition in animal tumour models: a systematic review and meta-analysis of the literature.
   Kleinendorst SC, Hooijmans CR, Muselaers S, Oosterwijk E, et al · · 2025 · cited 5× · PMID 40281282 · DOI 10.1007/s00259-025-07293-0
8. PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future.
   Ayzman A, Pachynski RK, Reimers MA. · · 2025 · cited 5× · PMID 40266437 · DOI 10.1007/s11864-025-01317-5