Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Sponsor: Clarity Pharmaceuticals Ltd
Sponsor score: 0
ClinicalTrials ID:NCT06056830
This clinical trial evaluates the diagnostic accuracy of 64Cu-SAR-bisPSMA PET in detecting nodal metastases in high-risk prostate cancer patients. Eligible participants are adults with untreated, confirmed adenocarcinoma, meeting specific high-risk criteria, and planning radical prostatectomy with lymph node dissection. Exclusions include recent high-energy radioisotope use and hypersensitivity to the drug. Participants receive a single 200MBq 64Cu-SAR-bisPSMA injection.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic- Phoenix | 85054 | Phoenix | Arizona |
| Greater Los Angeles VA Medical Center | 90073 | Los Angeles | California |
| Stanford University Medical Center | 94305-5105 | Stanford | California |
| Mayo Clinic- Jacksonville | 32224 | Jacksonville | Florida |
| NorthShore University Health System | 60026 | Glenview | Illinois |
| BAMF Health | 49503 | Grand Rapids | Michigan |
| Corewell Health | 49503 | Grand Rapids | Michigan |
| Mayo Clinic- Rochester | 55905 | Rochester | Minnesota |
| XCancer Omaha LLC | 68130 | Omaha | Nebraska |
| Urologic Specialists | 74146 | Tulsa | Oklahoma |
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