Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Recruiting · NCT06056830 · Interventional (participants receive a specific treatment) · Lead sponsor: Clarity Pharmaceuticals Ltd
View the official record on ClinicalTrials.gov →Interventions studied
64Cu-SAR-bisPSMA
What this trial is about
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
31 locations listed across 20 US states.
- University of Alabama Birmingham Hospital - Birmingham, Alabama, United States
- Mayo Clinic- Phoenix - Phoenix, Arizona, United States
- Arkansas Urology Research Center, LLC - Little Rock, Arkansas, United States
- Urology Group of Southern California - Los Angeles, California, United States
- Greater Los Angeles VA Medical Center - Los Angeles, California, United States
- UC Irvine Health - Orange, California, United States
- Stanford University Medical Center - Stanford, California, United States
- Mayo Clinic- Jacksonville - Jacksonville, Florida, United States
- Biogenix Molecular, LLC - Miami, Florida, United States
- NorthShore University Health System, Glenbrook Hospital - Glenview, Illinois, United States
- Indiana University School of Medicine - Indianapolis, Indiana, United States
- Wichita Urology Group - Wichita, Kansas, United States
- BAMF Health - Grand Rapids, Michigan, United States
- Corewell Health - Grand Rapids, Michigan, United States
- Mayo Clinic- Rochester - Rochester, Minnesota, United States
- XCancer Omaha LLC - Omaha, Nebraska, United States
- Mount Sinai Doctors Urology Faculty Practice - New York, New York, United States
- Duke University Medical Center - Durham, North Carolina, United States
- Urologic Specialists - Tulsa, Oklahoma, United States
- Oregon Urology - Springfield, Oregon, United States
- Carolina Urologic Research Center - Myrtle Beach, South Carolina, United States
- Urology Associates of Nashville - Nashville, Tennessee, United States
- Urology Clinics of North Texas - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- The Urology Place - San Antonio, Texas, United States
- Intermountain Health - Murray, Utah, United States
- University of Wisconsin - Madison, Wisconsin, United States
- Pan American Center for Oncology Trials, LLC - Ciudadela - San Juan, Puerto Rico
- St. Vincent's Sydney - Sydney, New South Wales, Australia
- Princess Alexandra Hospital - Woolloongabba, Queensland, Australia
- Fiona Stanley Hospital - Murdoch, Western Australia, Australia