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

NCT06056830 · tracked via the Priya Life Science USA tracker

Sponsor

Clarity Pharmaceuticals Ltd

Phase

Phase 3

Started

2023-12-21

Last updated

2026-09-11

Condition(s) studied

Prostate CancerProstatic Neoplasms

Investigational drug(s) / intervention(s)

64Cu-SAR-bisPSMA

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

Study summary

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

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases — Up to 16 weeks
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.

Trial sites (34)

Facility	City	Region	Status
University of Alabama Birmingham Hospital	Birmingham	Alabama	Recruiting
Mayo Clinic- Phoenix	Phoenix	Arizona	Recruiting
Arkansas Urology Research Center, LLC	Little Rock	Arkansas	Recruiting
Urology Group of Southern California	Los Angeles	California	Recruiting
Greater Los Angeles VA Medical Center	Los Angeles	California	Recruiting
UC Irvine Health	Orange	California	Recruiting
Stanford University Medical Center	Stanford	California	Recruiting
Mayo Clinic- Jacksonville	Jacksonville	Florida	Recruiting
Biogenix Molecular, LLC	Miami	Florida	Recruiting
NorthShore University Health System, Glenbrook Hospital	Glenview	Illinois	Recruiting
Indiana University School of Medicine	Indianapolis	Indiana	Recruiting
Wichita Urology Group	Wichita	Kansas	Recruiting
BAMF Health	Grand Rapids	Michigan	Recruiting
Corewell Health	Grand Rapids	Michigan	Recruiting
Mayo Clinic- Rochester	Rochester	Minnesota	Recruiting
XCancer Omaha LLC	Omaha	Nebraska	Recruiting
Albany Medical College, Department of Urology	Albany	New York	Recruiting
Mount Sinai Doctors Urology Faculty Practice	New York	New York	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
Urologic Specialists	Tulsa	Oklahoma	Recruiting
Oregon Urology	Springfield	Oregon	Recruiting
Carolina Urologic Research Center	Myrtle Beach	South Carolina	Recruiting
Urology Associates of Nashville	Nashville	Tennessee	Recruiting
Urology Austin, PLLC - Research Department	Austin	Texas	Recruiting
Urology Clinics of North Texas	Dallas	Texas	Recruiting
University of Texas Southwestern Medical Center	Dallas	Texas	Recruiting
The Urology Place	San Antonio	Texas	Recruiting
Intermountain Health	Murray	Utah	Recruiting
University of Wisconsin	Madison	Wisconsin	Recruiting
St. Vincent's Sydney	Sydney	New South Wales	Recruiting
Princess Alexandra Hospital	Woolloongabba	Queensland	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private Hospital	Nedlands	Western Australia	Recruiting
Pan American Center for Oncology Trials, LLC - Ciudadela	San Juan	Puerto Rico	Recruiting

More Clarity Pharmaceuticals Ltd trials in the USA

64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer Active, not recruiting

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) Recruiting

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Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer Recruiting

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Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06056830 on ClinicalTrials.gov ↗ ← All trials in the USA