Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy
Conditions
Prostate CancerDrugs
18F-Labeled Positron Emission Tomography (PET) Diagnostic AgentSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Herbert Lepor, MD
- 646-825-6340
- [email protected]
Principal Investigator
- Herbert Lepor, MD
Eligibility Criteria
Inclusion Criteria:
Eligible patients will include all men between age 18 -100 years old,-that have had RP, at the first point in time the PSA > 0.2 ng/ml.
Exclusion Criteria:
* Any contraindication for MRI imaging.
* Prior allergic reaction to rhPSMA-7.3 (18F).
* Patient refuses rhPSMA-7.3 (18F) PET/MRI.
Outcome Measures
Primary Outcome Measures
Change from Baseline in Percentage of Positive PCa Screens
Timeline
Last Updated
June 24, 2024Start Date
January 10, 2023Today
February 5, 2025Completion Date ( Estimated )
November 1, 2025
Sponsors of this trial
Lead Sponsor
NYU Langone HealthCollaborating Sponsors
Blue Earth Diagnostics