Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Recruiting now · Phase 3
Conditions studied: Prostate Cancer, Prostatic Neoplasms
In brief
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Key facts
- Study ID
- NCT06056830
- Run by
- Clarity Pharmaceuticals Ltd
- People needed
- 383
- Starts
- 2023-12-21
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- University of Alabama Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
- Mayo Clinic- Phoenix — Phoenix, Arizona, United States (enrolling)
- Arkansas Urology Research Center, LLC — Little Rock, Arkansas, United States (enrolling)
- Urology Group of Southern California — Los Angeles, California, United States (enrolling)
- Greater Los Angeles VA Medical Center — Los Angeles, California, United States (enrolling)
- UC Irvine Health — Orange, California, United States (enrolling)
- Stanford University Medical Center — Stanford, California, United States (enrolling)
- Mayo Clinic- Jacksonville — Jacksonville, Florida, United States (enrolling)
- Biogenix Molecular, LLC — Miami, Florida, United States (enrolling)
- NorthShore University Health System, Glenbrook Hospital — Glenview, Illinois, United States (enrolling)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
- Wichita Urology Group — Wichita, Kansas, United States (enrolling)
- BAMF Health — Grand Rapids, Michigan, United States (enrolling)
- Corewell Health — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic- Rochester — Rochester, Minnesota, United States (enrolling)
- XCancer Omaha LLC — Omaha, Nebraska, United States (enrolling)
- Mount Sinai Doctors Urology Faculty Practice — New York, New York, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Urologic Specialists — Tulsa, Oklahoma, United States (enrolling)
- Oregon Urology — Springfield, Oregon, United States (enrolling)
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
- Urology Associates of Nashville — Nashville, Tennessee, United States (enrolling)
- Urology Clinics of North Texas — Dallas, Texas, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- The Urology Place — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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