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

Last updated: April 7, 2026
Sponsor: Clarity Pharmaceuticals Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

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:
September 30, 2026

Connect with a study center

  • St. Vincent's Sydney

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • St. Vincent's Sydney

    Sydney 2147714, New South Wales 2155400
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch 8349091, Western Australia 2058645 6150
    Australia

    Site Not Available

  • University of Alabama Birmingham Hospital

    Birmingham, Alabama 35249-6830
    United States

    Active - Recruiting

  • Mayo Clinic- Phoenix

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic- Phoenix

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • Greater Los Angeles VA Medical Center

    Los Angeles, California 90073
    United States

    Active - Recruiting

  • Urology Group of Southern California

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305-5105
    United States

    Active - Recruiting

  • Greater Los Angeles VA Medical Center

    Los Angeles 5368361, California 5332921 90073
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford 5398563, California 5332921 94305-5105
    United States

    Site Not Available

  • Mayo Clinic- Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Biogenix Molecular, LLC

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Mayo Clinic- Jacksonville

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • NorthShore University Health System

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • NorthShore University Health System, Glenbrook Hospital

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • NorthShore University Health System

    Glenview 4893886, Illinois 4896861 60026
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University School of Medicine

    Indianapolis 4259418, Indiana 4921868 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

  • BAMF Health

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Active - Recruiting

  • Mayo Clinic- Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic- Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • XCancer Omaha LLC

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • XCancer Omaha LLC

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Site Not Available

  • Mount Sinai Doctors Urology Faculty Practice

    New York, New York 10029
    United States

    Active - Recruiting

  • Mount Sinai Doctors Urology Faculty Practice

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Urologic Specialists

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Urologic Specialists

    Tulsa 4553433, Oklahoma 4544379 74146
    United States

    Site Not Available

  • Oregon Urology

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Oregon Urology

    Springfield 5754005, Oregon 5744337 97477
    United States

    Site Not Available

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach 4588718, South Carolina 4597040 29572
    United States

    Site Not Available

  • Urology Associates PC

    Nashville, Tennessee 37209
    United States

    Site Not Available

  • Urology Associates of Nashville

    Nashville, Tennessee 37209
    United States

    Active - Recruiting

  • Urology Associates of Nashville

    Nashville 4644585, Tennessee 4662168 37209
    United States

    Site Not Available

  • 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

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390-8896
    United States

    Active - Recruiting

  • Urology Clinics of North Texas

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • The Urology Place

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

  • Intermountain Health

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Intermountain Health

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Site Not Available

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