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
Trial Information
Current as of July 24, 2025
Recruiting
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.
About Clarity Pharmaceuticals Ltd
Clarity Pharmaceuticals Ltd. is a pioneering biopharmaceutical company focused on advancing innovative radiopharmaceutical therapies for the treatment of cancer and other serious diseases. With a commitment to improving patient outcomes, Clarity leverages cutting-edge technology and a robust pipeline of targeted therapies designed to enhance precision medicine. The company’s multidisciplinary team of experts collaborates to develop safe and effective solutions that address unmet medical needs, ensuring rigorous adherence to regulatory standards and ethical practices throughout the clinical trial process. Through its dedication to research and development, Clarity Pharmaceuticals aims to transform the landscape of oncology treatment and improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Dallas, Texas, United States
Madison, Wisconsin, United States
Jacksonville, Florida, United States
Myrtle Beach, South Carolina, United States
Woolloongabba, Queensland, Australia
Los Angeles, California, United States
Dallas, Texas, United States
Glenview, Illinois, United States
Murdoch, Western Australia, Australia
Murray, Utah, United States
Rochester, Minnesota, United States
San Antonio, Texas, United States
Nashville, Tennessee, United States
Grand Rapids, Michigan, United States
Grand Rapids, Michigan, United States
Phoenix, Arizona, United States
Omaha, Nebraska, United States
Tulsa, Oklahoma, United States
Sydney, New South Wales, Australia
Nashville, Tennessee, United States
Stanford, California, United States
Dallas, Texas, United States
Springfield, Oregon, United States
New York, New York, United States
Patients applied
Trial Officials
Clarity Pharmaceuticals
Study Director
Clarity Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported