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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678322
• Other study ID #: 22-00547
• Status: Recruiting
• Phase: Phase 3
• Start date: January 31, 2023
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Herbert Lepor, MD
• Phone: 646-825-6340
• Email: Herbert.lepor[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Smilow Comprehensive Prostate Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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