CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 48 target
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed progressive metastatic CRPC by PCWG3 criteria
  • ✓Male, at least 18 years old
  • ✓Castrate serum testosterone <50 ng/dL at study entry
  • ✓Prior progression on at least one second-generation androgen signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Key exclusion· 22
  • ✕De novo small cell neuroendocrine prostate cancer
  • ✕Soft tissue lesions negative on PSMA PET (lymph nodes >1.5 cm short axis, visceral/soft tissue >1 cm)
  • ✕Systemic anti-cancer therapy within 14 days or 5 half-lives prior to study (except LHRH analogues)
  • ✕Untreated brain metastases at study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT05766371Phase 2RecruitingOn TrackUpdated 2mo ago
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A Phase 2 Study of Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Metastatic Castration Resistant Prostate Cancer

University of California, San Francisco·interventional·Posted Mar 13, 2023·Updated Apr 17, 2026

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and 177Lu-PSMA-617 for Castrate Resistant Prostate Cancer and 3 related conditions. Currently recruiting, targeting 48 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCastrate Resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Carcinoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Prostate Cancer Foundation

Timeline

Phase 2Recruiting
202320242025202620272028202920302031
First PostedMar 13, 2023
Enrollment StartDec 15, 2023
Primary CompletionMay 31, 2027
Study CompletionMay 31, 2031
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 3.3 years agoPrimary completion in 11 months

Interventions

Pembrolizumabdrug

Given IV

177Lu-PSMA-617drug

Given IV