NCT06056830RecruitingPhase 3
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 383 (estimated)
- First submitted
- 21 Sept 2023
- Start date
- 21 Dec 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Diseases
- Prostate cancer
- NCT number
- NCT06056830
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 383
- From 21 Dec 2023 to the primary completion date, 30 Sept 2026
- 34 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
Other illness
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
Other
- Patients with known predominant small cell or neuroendocrine PC.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| St. Vincent's Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Pan American Center for Oncology Trials LLC - Ciudadela Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Albany Medical College, Department of Urology Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Urology Austin, PLLC - Research Department Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Alabama Birmingham Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Urology Clinics of North Texas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| NorthShore University Health System - Glenbrook Hospital Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Corewell Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Arkansas Urology Research Center, LLC Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Greater Los Angeles VA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Urology Group of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Biogenix Molecular, LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Intermountain Health Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Urology Associates of Nashville Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Mount Sinai Doctors Urology Faculty Practice Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| XCancer Omaha LLC Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| UC Irvine Health Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Mayo Clinic Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| The Urology Place Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Oregon Urology Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Urologic Specialists Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| Wichita Urology Group Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.