Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Launched by CLARITY PHARMACEUTICALS LTD · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a special imaging test called 64Cu-SAR-bisPSMA PET, which helps doctors find cancer that may have spread to nearby lymph nodes in men with high-risk prostate cancer. The goal is to see how well this test works before patients undergo surgery to remove their prostate and possibly some surrounding tissue.

To participate in the trial, men must be at least 18 years old and have recently been diagnosed with prostate cancer that is considered high-risk according to certain medical guidelines. This includes those with advanced cancer stages or higher levels of a specific protein called PSA. Participants will need to agree to take part by signing a consent form and will be monitored throughout the study. It's important to note that men who have had certain other treatments or have specific types of prostate cancer may not be eligible. This study is currently recruiting participants, and it's a great opportunity for those who qualify to help advance cancer research.

Gender

MALE

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.