Recruiting

Phase 3

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

Sponsor:

Clarity Pharmaceuticals Ltd

Code:

NCT06056830

Conditions

Prostate Cancer

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

64Cu-SAR-bisPSMA

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Prostatic Neoplasms

Study ID

NCT06056830

Start date

Dec 21, 2023

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

383 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 64Cu-SAR-bisPSMA

200MBq 64Cu-SAR-bisPSMA.

Interventions

64Cu-SAR-bisPSMA

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

Primary outcome measure

Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases [ Time Frame: Up to 16 weeks ]

Central Contacts and Locations

Central contacts

Clarity Pharmaceuticals

+61 (0) 2 9209 4037 clinicaltrials@claritypharmaceuticals.com

Locations

University of Alabama Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35249-6830

Contacts

Ashley Barnes

205-996-5784 alstrickland@uabmc.edu

Sebastian Eady

205-996-2636 smeady@uabmc.edu

Principal Investigator:

Jonathan E McConathy, MD, PhD

Mayo Clinic- Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

Arkansas Urology Research Center, LLC

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Katie

5012198900 research@arkansasurology.com

Sarah

5012198900 research@arkansasurology.com

Principal Investigator:

R. Jonathan Henderson, MD

Urology Group of Southern California

Recruiting

Los Angeles, California, United States, 90017

Contacts

Carlos Lopez

clopez@folioclinicalresearch.com

Yvette Zuniga

yzuniga@folioclinicalresearch.com

Principal Investigator:

John Kowalczyk

Greater Los Angeles VA Medical Center

Recruiting

Los Angeles, California, United States, 90073

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Contacts

877-827-8839 ucstudy@hs.uci.edu

Principal Investigator:

Edward Uchio, MD, FACS, CPI

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305-5105

Mayo Clinic- Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Biogenix Molecular, LLC

Recruiting

Miami, Florida, United States, 33165

Contacts

Jerry Joseph, FMD

786-791-1799 jjoseph@cira-health.com

Principal Investigator:

Serguei A Castaneda, MD

NorthShore University Health System, Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Ashlee Frazee, PhD

(317)278-4959 amfrazee@iu.edu

Principal Investigator:

Clint D Bahler, MD

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Principal Investigator:

Timothy Richardson, MD

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Clayton McNamara

ResearchClinicalTeam@bamfhealth.com

Principal Investigator:

Harshad Kulkarni, MD

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Josh Dejong

616-267-7566 joshua.dejong@corewellhealth.org

Rachel Schmidt, BSN, RN

616-486-1545 rachel.schmidt@corewellhealth.org

Principal Investigator:

Conrad Tobert

Mayo Clinic- Rochester

Recruiting

Rochester, Minnesota, United States, 55905

XCancer Omaha LLC

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Tony Romero

402-991-8468 tromero@gucancer.com

Principal Investigator:

Luke Nordquist, MD

Mount Sinai Doctors Urology Faculty Practice

Recruiting

New York, New York, United States, 10029

Contacts

Monali Fatterpekar

212-241-9955 monali.fatterpekar@mountsinai.org

Principal Investigator:

Ashutosh Tewari, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Alex Sents, MA, MPH

(919) 668-0739 alex.sents@duke.edu

Principal Investigator:

Terence Z Wong, MD, PhD, FACR

Urologic Specialists

Recruiting

Tulsa, Oklahoma, United States, 74146

Oregon Urology

Recruiting

Springfield, Oregon, United States, 97477

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Principal Investigator:

Neal Shore, MD

Urology Associates of Nashville

Recruiting

Nashville, Tennessee, United States, 37209

Urology Clinics of North Texas

Recruiting

Dallas, Texas, United States, 75231

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-8896

Contacts

Orhan Oz, MD

214-645-1568 RCRO@UTSouthwestern.edu

The Urology Place

Recruiting

San Antonio, Texas, United States, 78240

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

Clarity Pharmaceuticals Ltd

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Clarity Pharmaceuticals Ltd on 2026-05-14.