Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Recruiting now · Phase 3

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

Key facts

Study ID

NCT06235151

Run by

Curium US LLC

People needed

439

Starts

2024-04-01

Expected to finish

2026-09-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically proven prostate adenocarcinoma.
• Planned prostatectomy with pelvic lymph node dissection.
• Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
• Male aged greater than or equal to 18 years.
• Able to understand and provide signed written informed consent.

You may not qualify if…

• Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.
• Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
• Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
• Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
• Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.
• Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
• Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.

Where it is running

• Fred Hutchinson Cancer Center — Seatle, Washington, United States (enrolling)
• Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• Tower Urology — Los Angeles, California, United States (enrolling)
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• University of California, Irvine — Orange, California, United States (enrolling)
• San Francisco VA Medical Center — San Francisco, California, United States (enrolling)
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• James J. Peters VA Medical Center — The Bronx, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Dayton Physicians Network / Greater Dayton Cancer Center — Kettering, Ohio, United States (enrolling)
• Hollings Cancer Center — Charleston, South Carolina, United States (enrolling)
• Carolina Urologic Research Center, LLC — Myrtle Beach, South Carolina, United States (enrolling)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)
• Excel Diagnostics and Nuclear Oncology Center — Houston, Texas, United States (enrolling)
• Urology San Antonio — San Antonio, Texas, United States (enrolling)
• The Urology Place — San Antonio, Texas, United States (enrolling)
• Urology Centers of Alabama — Homewood, Alabama, United States (enrolling)
• Stanford Hospital & Clinics — Stanford, California, United States (enrolling)
• CIRA Health — Miami, Florida, United States (enrolling)
• Sarasota Memorial Health Care System — Sarasota, Florida, United States (enrolling)
• Florida Urology Partners — Tampa, Florida, United States (enrolling)
• Edward Hines Jr. VA Hospital — Hines, Illinois, United States (enrolling)
• Urology of Indiana, LLC — Carmel, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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