Status:
RECRUITING
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Lead Sponsor:
Clarity Pharmaceuticals Ltd
Conditions:
Prostate Cancer
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT06056830
Start Date
December 21 2023
End Date
September 1 2026
Last Update
December 17 2025
Active Locations (23)
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1
Mayo Clinic- Phoenix
Phoenix, Arizona, United States, 85054
2
Greater Los Angeles VA Medical Center
Los Angeles, California, United States, 90073
3
Stanford University Medical Center
Stanford, California, United States, 94305-5105
4
Mayo Clinic- Jacksonville
Jacksonville, Florida, United States, 32224