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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent; Device: PET MRI Imaging

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Herbert Lepor, MD; Phone Number: 646-825-6340; Email: Herbert.lepor@nyulangone.org
• Study Contact Backup: Name: Rozalba Gogaj, MD, MPH; Phone Number: 646-825-6356; Email: Rozalba.gogaj@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Smilow Comprehensive Prostate Cancer Center
      • Contact: Herbert Lepor, MD; Phone Number: 646-825-6340; Email: Herbert.lepor@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with PSA > 0.2 ng/ml following Radical Prostatectomy; 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.

Drug: 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent; Under development for the diagnosis of prostate cancer by Blue Earth Diagnostics. rhPSMA-7.3 (18F) will be administered intravenously as a single-dose injection. The molecular structure of the drug substance comprises a prostate-specific membrane antigen (PSMA) binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor moiety and a gallium chelator complex.; Other Names: rhPSMA-7.3 (18F); Device: PET MRI Imaging; rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Percentage of Positive PCa Screens	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.	Baseline, Up to Month 24

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Blue Earth Diagnostics
• Investigators: Principal Investigator: Herbert Lepor, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 22-00547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes