Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Purpose
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Conditions
- Prostate Cancer
- Prostatic Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 64Cu-SAR-bisPSMA |
200MBq 64Cu-SAR-bisPSMA. |
|
Recruiting Locations
University of Alabama Birmingham Hospital
Birmingham, Alabama 35249-6830
Birmingham, Alabama 35249-6830
More Details
- Status
- Recruiting
- Sponsor
- Clarity Pharmaceuticals Ltd