Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma, Biochemical Recurrence of Malignant Neoplasm of Prostate

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 recurrent prostate cancer after radical prostatectomy or radiation therapy.

Key facts

Study ID

NCT06235099

Run by

Curium US LLC

People needed

235

Starts

2024-04-01

Expected to finish

2025-02-18

Last updated by the study team

2026-02-18

Who can join

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

You may qualify if…

• Patients with histologically proven prostate adenocarcinoma.
• Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.
• Recurrence of disease defined as:
• Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or
• Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.
• 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 (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.
• 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 scan) 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

• Providence Medical Foundation — Fullerton, California, United States
• Tower Urology — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• University of California, Irvine — Orange, California, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• Providence Saint John's Health Center — Santa Monica, California, United States
• Stanford Hospital & Clinics — Stanford, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Biogenix Molecular, LLC — Miami, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Edward Hines Jr VA Hospital — Hines, Illinois, United States
• Urology of Indiana, LLC — Carmel, Indiana, United States
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• The University of Kansas Hospital — Kansas City, Kansas, United States
• M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• SSM Health Saint Louis University Hospital — St Louis, Missouri, United States
• John Cochran VA Medical Center — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Great Plains Health, Diagnostic Imaging — North Platte, Nebraska, United States
• XCancer — Omaha, Nebraska, United States
• Queens Hospital Center — Jamaica, New York, United States
• James J. Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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