Clinical Trial

Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy

Active, Not Recruiting Phase 3
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Summary
All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA \> 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidence of disease recurrence. Early identification of the site(s) of disease recurrence enables early salvage intervention. Men will be eligible for the study at the point in time their post-prostatectomy PSA level first becomes \>0.2 ng/ml. Only those patients with rhPSMA-7.3 (18F) identifiable disease (local, nodal or systemic) will be offered salvage intervention per standard of care. All patients with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA is \> 0,5 ng/ml or one year after the initial PET study. The salvage interventions will be at the discretion of the investigator. The study will compare the diagnostic yield of the first and second rhPSMA-7.3 (18F) studies.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-12-28; most recent amendment 2026-03-04.
Status change: Recruiting → Active, Not Recruiting 2025-04-22
Status change: Not Yet Recruiting → Recruiting 2023-02-08
Trial Details
NCT Number NCT05678322
Lead Sponsor NYU Langone Health
Collaborators: Blue Earth Diagnostics
Conditions Prostate Cancer
Enrollment 26 participants
Start Date 2023-01-31
Primary Completion 2025-05-08 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-25