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Clinical Trials in the USA / NCT06056830
Recruiting Phase 3

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
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.

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)

FacilityCityRegionStatus
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 and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) Recruiting
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer Active, not recruiting

Other trials for the same condition

A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life Active, not recruiting
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors Active, not recruiting
Stratagen Quantitative Prostate MRI Platform Pilot Study Active, not recruiting
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy Starting soon
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