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RecruitingInterventionalPhase 3

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

NCT ID: NCT06056830Sponsor: Clarity Pharmaceuticals LtdLast updated: 2026-05-14

Summary

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

Arms & interventions

  • Drug64Cu-SAR-bisPSMA

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

Outcome measures

Primary

  • Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases

    Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.

    Time frame: Up to 16 weeks

Secondary

  • Safety and tolerability of 64Cu-SAR-bisPSMA

    Time frame: Up to 16 weeks

  • Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers

    Time frame: Up to 16 weeks

  • PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs

    Time frame: Up to 16 weeks

  • Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer

    Time frame: Up to 16 weeks

  • Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching

    Time frame: Up to 16 weeks

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (27)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35249-6830

Recruiting
Ashley Barnes · Contact
205-996-5784alstrickland@uabmc.edu
Sebastian Eady · Contact
205-996-2636smeady@uabmc.edu
Jonathan E McConathy, MD, PhD · Principal Investigator

Mayo Clinic- Phoenix

Phoenix, Arizona, 85054

Recruiting
Jack Andrews, MD · Contact

Arkansas Urology Research Center, LLC

Little Rock, Arkansas, 72211

Recruiting
Katie · Contact
5012198900research@arkansasurology.com
Sarah · Contact
5012198900research@arkansasurology.com
R. Jonathan Henderson, MD · Principal Investigator

Urology Group of Southern California

Los Angeles, California, 90017

Recruiting
Carlos Lopez · Contact
clopez@folioclinicalresearch.com
Yvette Zuniga · Contact
yzuniga@folioclinicalresearch.com
John Kowalczyk · Principal Investigator

Greater Los Angeles VA Medical Center

Los Angeles, California, 90073

Recruiting
Gholam R. Berenji, MD · Contact

UC Irvine Health

Orange, California, 92868

Recruiting
· Contact
877-827-8839ucstudy@hs.uci.edu
Edward Uchio, MD, FACS, CPI · Principal Investigator

Stanford University Medical Center

Stanford, California, 94305-5105

Recruiting
Hong Song, MD, PhD · Contact

Mayo Clinic- Jacksonville

Jacksonville, Florida, 32224

Recruiting
Ephraim Parent, MD · Contact

Biogenix Molecular, LLC

Miami, Florida, 33165

Recruiting
Jerry Joseph, FMD · Contact
786-791-1799jjoseph@cira-health.com
Serguei A Castaneda, MD · Principal Investigator

NorthShore University Health System, Glenbrook Hospital

Glenview, Illinois, 60026

Recruiting
Brian Helfand, MD · Contact

Indiana University School of Medicine

Indianapolis, Indiana, 46202

Recruiting
Ashlee Frazee, PhD · Contact
(317)278-4959amfrazee@iu.edu
Clint D Bahler, MD · Principal Investigator

Wichita Urology Group

Wichita, Kansas, 67226

Recruiting
Timothy Richardson, MD · Principal Investigator

BAMF Health

Grand Rapids, Michigan, 49503

Recruiting
Clayton McNamara · Contact
ResearchClinicalTeam@bamfhealth.com
Harshad Kulkarni, MD · Principal Investigator

Corewell Health

Grand Rapids, Michigan, 49503

Recruiting
Josh Dejong · Contact
616-267-7566joshua.dejong@corewellhealth.org
Rachel Schmidt, BSN, RN · Contact
616-486-1545rachel.schmidt@corewellhealth.org
Conrad Tobert · Principal Investigator

Mayo Clinic- Rochester

Rochester, Minnesota, 55905

Recruiting
Jeffrey Karnes, MD · Contact

XCancer Omaha LLC

Omaha, Nebraska, 68130

Recruiting
Tony Romero · Contact
402-991-8468tromero@gucancer.com
Luke Nordquist, MD · Principal Investigator

Mount Sinai Doctors Urology Faculty Practice

New York, New York, 10029

Recruiting
Monali Fatterpekar · Contact
212-241-9955monali.fatterpekar@mountsinai.org
Ashutosh Tewari, MD · Principal Investigator

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting
Alex Sents, MA, MPH · Contact
(919) 668-0739alex.sents@duke.edu
Terence Z Wong, MD, PhD, FACR · Principal Investigator
Judd W Moul, MD, FACS · Principal Investigator

Urologic Specialists

Tulsa, Oklahoma, 74146

Recruiting
Shaun GS Grewal, MD · Contact

Oregon Urology

Springfield, Oregon, 97477

Recruiting
Bryan Mehllhaff, MD · Contact

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Recruiting
Neal Shore, MD · Principal Investigator

Urology Associates of Nashville

Nashville, Tennessee, 37209

Recruiting
David Morris, MD · Contact

Urology Clinics of North Texas

Dallas, Texas, 75231

Recruiting
Alexander Parker, MD · Contact

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8896

Recruiting
Orhan Oz, MD · Contact
214-645-1568RCRO@UTSouthwestern.edu
Radiology Clinical Research Office · Contact

The Urology Place

San Antonio, Texas, 78240

Recruiting
Naveen Kella, MD · Contact

Intermountain Health

Murray, Utah, 84107

Recruiting
Dustin L. Boothe, MD · Contact

University of Wisconsin

Madison, Wisconsin, 53705

Recruiting
Nandakumar Menon, MD · Contact