Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Last updated: April 29, 2025
Sponsor: Clarity Pharmaceuticals Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

64Cu-SAR-bisPSMA

Clinical Study ID

NCT06056830
CLP04
  • Ages > 18
  • Male

Study Summary

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years of age.

  • Signed informed consent.

  • Untreated, histologically confirmed adenocarcinoma of the prostate.

  • High-risk or greater PC defined by National Comprehensive Cancer Network GuidelinesVersion 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).

  • Patients electing to undergo RP with PLND.

Exclusion

Exclusion Criteria:

  • Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5physical half-lives prior to Day 1.

  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.

  • Patients with known predominant small cell or neuroendocrine PC.

Study Design

Total Participants: 383
Treatment Group(s): 1
Primary Treatment: 64Cu-SAR-bisPSMA
Phase: 3
Study Start date:
December 21, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • St. Vincent's Sydney

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Mayo Clinic- Phoenix

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Greater Los Angeles VA Medical Center

    Los Angeles, California 90073
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305-5105
    United States

    Active - Recruiting

  • Mayo Clinic- Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • NorthShore University Health System

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • BAMF Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Mayo Clinic- Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • XCancer Omaha LLC

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Mount Sinai Doctors Urology Faculty Practice

    New York, New York 10029
    United States

    Active - Recruiting

  • Urologic Specialists

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Oregon Urology

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Urology Associates PC

    Nashville, Tennessee 37209
    United States

    Active - Recruiting

  • Urology Associates of Nashville

    Nashville, Tennessee 37209
    United States

    Active - Recruiting

  • UT Southwest Medical Center

    Dallas, Texas 75390-8896
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390-8896
    United States

    Active - Recruiting

  • Urology Clinics of North Texas

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • The Urology Place

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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