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NCT Number: NCT05678322

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Smilow Comprehensive Prostate Cancer Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: rhPSMA-7.3 (18F)

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.

Primary outcomes

  1. Positive PCa Screens at Baseline

    Time frame: Baseline

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

  2. Positive PCa Screens at Second Scan Visit

    Time frame: Up to Month 24

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 10, 2023
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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