Clinical Trial

Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy

Recruiting Phase 2
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Summary
Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \[GG4\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-01-22; most recent amendment 2026-03-20.
Status change: Not Yet Recruiting → Recruiting 2025-03-07
Trial Details
NCT Number NCT06798558
Lead Sponsor Hackensack Meridian Health
Collaborators: Lombardi Comprehensive Cancer Center, Novartis
Conditions Prostate Adenocarcinoma
Enrollment 54 participants
Start Date 2025-03-05
Primary Completion 2029-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-23