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NCT06056830PHASE3Recruiting

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

Clarity Pharmaceuticals Ltd

Start Date

12/21/2023

Completion Date

9/1/2026

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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 Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA \>20 ng/mL). * Patients electing to undergo RP with PLND. Exclusion Criteria: * Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical 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.

Interventions

DRUG

64Cu-SAR-bisPSMA

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Conditions

Prostate CancerProstatic Neoplasms

Locations

University of Alabama Birmingham Hospital

Birmingham, Alabama 35249-6830

United States

Mayo Clinic- Phoenix

Phoenix, Arizona 85054

United States

Arkansas Urology Research Center, LLC

Little Rock, Arkansas 72211

United States

Urology Group of Southern California

Los Angeles, California 90017

United States

Greater Los Angeles VA Medical Center

Los Angeles, California 90073

United States

UC Irvine Health

Orange, California 92868

United States

Stanford University Medical Center

Stanford, California 94305-5105

United States

Mayo Clinic- Jacksonville

Jacksonville, Florida 32224

United States

Biogenix Molecular, LLC

Miami, Florida 33165

United States

NorthShore University Health System, Glenbrook Hospital

Glenview, Illinois 60026

United States

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

Wichita Urology Group

Wichita, Kansas 67226

United States

BAMF Health

Grand Rapids, Michigan 49503

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Mayo Clinic- Rochester

Rochester, Minnesota 55905

United States

XCancer Omaha LLC

Omaha, Nebraska 68130

United States

Mount Sinai Doctors Urology Faculty Practice

New York, New York 10029

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Urologic Specialists

Tulsa, Oklahoma 74146

United States

Oregon Urology

Springfield, Oregon 97477

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

Urology Associates of Nashville

Nashville, Tennessee 37209

United States

Urology Clinics of North Texas

Dallas, Texas 75231

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390-8896

United States

The Urology Place

San Antonio, Texas 78240

United States

Intermountain Health

Murray, Utah 84107

United States

University of Wisconsin

Madison, Wisconsin 53705

United States

St. Vincent's Sydney

Sydney, New South Wales

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland

Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150

Australia

Pan American Center for Oncology Trials, LLC - Ciudadela

San Juan, 00918

Puerto Rico