Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

Last updated: September 10, 2025
Sponsor: Blue Earth Diagnostics
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

Positron emission tomography scan

rhPSMA-7.3 (18F) Injection

Clinical Study ID

NCT04186845
BED-PSMA-302
  • Ages > 18
  • Male

Study Summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is male and aged >18 years old.

  2. History of localized adenocarcinoma of the prostate with prior curative intenttreatment.

  3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

  • Following Radical Prostatectomy: PSA >0.2 ng/mL

  • Following Radiotherapy: nadir +2 ng/mL.

  1. Potentially eligible for salvage therapy with curative intent.

Exclusion

Exclusion Criteria:

  1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.

  2. Patients currently receiving Androgen Deprivation Therapy (ADT).

Study Design

Total Participants: 391
Treatment Group(s): 2
Primary Treatment: Positron emission tomography scan
Phase: 3
Study Start date:
May 04, 2020
Estimated Completion Date:
April 28, 2021

Study Description

The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

Connect with a study center

  • Turku University Hospital

    Turku, FI-20520
    Finland

    Site Not Available

  • Turku University Hospital

    Turku 633679, FI-20520
    Finland

    Site Not Available

  • CWZ

    Nijmegen, 6532
    Netherlands

    Site Not Available

  • CWZ

    Nijmegen 2750053, 6532
    Netherlands

    Site Not Available

  • Maxima MC

    Veldhoven, 5504 DB
    Netherlands

    Site Not Available

  • Maxima MC

    Veldhoven 2745706, 5504 DB
    Netherlands

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Tower Urology

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California Irvine Medical Center (UCIMC)

    Orange, California 92868
    United States

    Site Not Available

  • John Wayne Cancer Institute

    Santa Monica, California 90403
    United States

    Site Not Available

  • Tower Urology

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • University of California Irvine Medical Center (UCIMC)

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • John Wayne Cancer Institute

    Santa Monica 5393212, California 5332921 90403
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northside Hospital

    Austell, Georgia 30342
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Northside Hospital

    Austell 4180564, Georgia 4197000 30342
    United States

    Site Not Available

  • Northshore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Northshore University HealthSystem

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood 4901514, Illinois 4896861 60153
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Towson, Maryland 21204
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Towson 4371582, Maryland 4361885 21204
    United States

    Site Not Available

  • University of Michigan Ann Arbor

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Michigan Ann Arbor

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Montefiore Hospital

    Bronx, New York 10461
    United States

    Site Not Available

  • Queens Hospital Center (QHC - Queens Cancer Center

    Jamaica, New York 11432
    United States

    Site Not Available

  • Mount Sinai Faculty Practice Associates

    New York, New York 10029
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Queens Hospital Center (QHC - Queens Cancer Center

    Jamaica 5122520, New York 5128638 11432
    United States

    Site Not Available

  • Mount Sinai Faculty Practice Associates

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook 5139865, New York 5128638 11794
    United States

    Site Not Available

  • Montefiore Hospital

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27701
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27701
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • MidLantic Urology

    Philadelphia, Pennsylvania 19004
    United States

    Site Not Available

  • MidLantic Urology

    Philadelphia 4560349, Pennsylvania 6254927 19004
    United States

    Site Not Available

  • MD Anderson Hospital

    Houston, Texas 77054
    United States

    Site Not Available

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MD Anderson Hospital

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Urology San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • University of Virginia - Health Science Center

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • University of Virginia - Health Science Center

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

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