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Brief Title: Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
Official Title: A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer
Study ID: NCT06235099
Brief Summary: 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.
Detailed Description: The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection. The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Florida Urology Partners, Tampa, Florida, United States
Indiana University Health Neuroscience Center, Indianapolis, Indiana, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Great Plains Health, Diagnostic Imaging, North Platte, Nebraska, United States
XCancer, Omaha, Nebraska, United States
James J. Peters VA Medical Center, Bronx, New York, United States
Excel Diagnostics and Nuclear Oncology Center, Houston, Texas, United States
Urology San Antonio, San Antonio, Texas, United States