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RECRUITING
NCT06056830
PHASE3

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

Sponsor: Clarity Pharmaceuticals Ltd

View on ClinicalTrials.gov

Summary

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

Official title: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

383

Start Date

2023-12-21

Completion Date

2026-09

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

64Cu-SAR-bisPSMA

All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Locations (27)

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Mayo Clinic- Phoenix

Phoenix, Arizona, United States

Urology Group of Southern California

Los Angeles, California, United States

Greater Los Angeles VA Medical Center

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

Mayo Clinic- Jacksonville

Jacksonville, Florida, United States

Biogenix Molecular, LLC

Miami, Florida, United States

NorthShore University Health System, Glenbrook Hospital

Glenview, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

BAMF Health

Grand Rapids, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Mayo Clinic- Rochester

Rochester, Minnesota, United States

XCancer Omaha LLC

Omaha, Nebraska, United States

Mount Sinai Doctors Urology Faculty Practice

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Urologic Specialists

Tulsa, Oklahoma, United States

Oregon Urology

Springfield, Oregon, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Associates of Nashville

Nashville, Tennessee, United States

Urology Clinics of North Texas

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The Urology Place

San Antonio, Texas, United States

Intermountain Health

Murray, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

St. Vincent's Sydney

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia