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

Phase 3

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent; Device: PET MRI Imaging

• Registration Number: NCT05678322
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2022-12-28
• Study First Posted: 2023-01-10
• Study Start: 2023-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with PSA > 0.2 ng/ml following Radical Prostatectomy	18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent	Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA \>0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA\> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator.
Patients with PSA > 0.2 ng/ml following Radical Prostatectomy	PET MRI Imaging	Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA \>0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA\> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Percentage of Positive PCa Screens	Baseline, Up to Month 24	This measurement will calculate the change in the percentage of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan vs. the second scan.

Trial Locations

Locations (1)

Smilow Comprehensive Prostate Cancer Center; 🇺🇸 New York, New York, United States