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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Feb 17, 2026, no change to tracked fieldsv4-v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    • Primary and study completion dates: Feb 2029 to Mar 2029
    • Start date changed from estimate of Feb 2025 to Mar 5, 2025
    v3
  3. Primary and study completion dates: Jan 2029 to Feb 2029
    • Start date: Jan 2025 to Feb 2025
    • Site contacts updated at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06798558
Lead Sponsor Hackensack Meridian Health
Collaborators: Lombardi Comprehensive Cancer Center, Novartis
Conditions
(from sponsor)		 Prostate Adenocarcinoma
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov