Using 64Cu-SAR-bisPSMA PET to detect prostate cancer spread before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of 64Cu-SAR-bisPSMA positron emission tomography (PET) in identifying regional nodal metastases in patients with high-risk prostate cancer. Participants will undergo this imaging technique prior to radical prostatectomy to determine its diagnostic performance. The study focuses on patients who have untreated, histologically confirmed adenocarcinoma of the prostate and meet specific high-risk criteria. The results could provide valuable insights into the staging of prostate cancer and guide treatment decisions.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic- Phoenix
  Phoenix, Arizona, United States Recruiting
• Arkansas Urology Research Center, LLC
  Little Rock, Arkansas, United States Recruiting
• Urology Group of Southern California
  Los Angeles, California, United States Recruiting
• Greater Los Angeles VA Medical Center
  Los Angeles, California, United States Recruiting
• UC Irvine Health
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Clarity Pharmaceuticals
• Email: clinicaltrials@claritypharmaceuticals.com
• Phone: +61 (0) 2 9209 4037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.