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

NCT05678322 | Active Not Recruiting Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: 22-00547
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Positive PCa Screens at Baseline

  This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan.

  Baseline

• Positive PCa Screens at Second Scan Visit

  This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the second rhPSMA-7.3 (18F) scan.

  Up to Month 24

Study Arms (1)

Patients with PSA > 0.2 ng/ml following Radical Prostatectomy

EXPERIMENTAL

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; Device: PET MRI Imaging

Interventions

PET MRI Imaging DEVICE

rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan.

Patients with PSA > 0.2 ng/ml following Radical Prostatectomy

18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent DRUG

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.

Also known as: rhPSMA-7.3 (18F)

Patients with PSA > 0.2 ng/ml following Radical Prostatectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any contraindication for MRI imaging.
• Prior allergic reaction to rhPSMA-7.3 (18F).
• Patient refuses rhPSMA-7.3 (18F) PET/MRI.

Sponsors & Collaborators

• NYU Langone Health: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Smilow Comprehensive Prostate Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Majlinda Tafa, MD
• Organization: NYU Langone Health

Majlinda.Tafa@nyulangone.org

(646) 825-6338

Study Officials

• Herbert Lepor, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: January 31, 2023
• Primary Completion: May 8, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)