Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study
About This Trial
- This clinical trial is testing a new type of imaging scan to see how accurately it detects whether cancer has spread to nearby lymph nodes.
- It is open to adults with high-risk prostate cancer who have already decided to have surgery to remove their prostate and surrounding lymph nodes.
- Before your planned surgery, you would receive an injection of a special imaging substance through a vein and undergo a scan.
- Before considering this study, patients should know that it tests an imaging tool rather than a new cancer treatment, and having had certain recent radioactive medications or imaging procedures may disqualify you.
More Information
- The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing a new type of imaging scan to see how accurately it detects whether cancer has spread to nearby lymph nodes.
Study Details
- Start Date: December 21, 2023
- Lead Sponsor: Clarity Pharmaceuticals Ltd
Full 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.
Treatments
- Drug: 64Cu-SAR-bisPSMA