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

StatusActive, Not Recruiting
PhasePhase 3
Started2023-01-31
View on ClinicalTrials.gov ↗

Amendment history

2026-03-04
minor
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v6
Primary completion dateestimated 2025-05→confirmed 2025-05-08
Completion date2025-11→2026-11
Results first postednot stated→2026-03-25
Primary endpoints1 to 2 entries
Change from Baseline in Percentage of Positive PCa Screens at Baseline Positive PCa Screens at Second Scan Visit
2025-04-22
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2024-06-20
minor
Study Status, Study Design, Contacts/Locations v4
Primary completion date2024-03→2025-05
Completion date2025-06→2025-11
Enrollment target22→26
2024-01-09
minor
Study Status, Study Design v3
Primary completion date2024-01→2024-03
Enrollment target24→22
2023-02-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-01→confirmed 2023-01-31
Study sitesdetails revised at 1 of 1 site
2023-01-09
minor
Study Status v1
Re-verified, no change to tracked fields
2022-12-28
minor
Original filing
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.
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