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Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Sponsor: Curium US LLC
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 newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
Official title: Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
439
Start Date
2024-04-01
Completion Date
2026-09
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Copper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Locations (43)
Arkansas Urology
Little Rock, Arkansas, United States
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
UCSF Helen Diller Family Comprehensive Cancer 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 Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
CIRA Health
Miami, Florida, United States
Sarasota Memorial Health Care System
Sarasota, 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
IU 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
United Theranostics
Glen Burnie, Maryland, United States
VA Boston Healthcare System
Boston, Massachusetts, 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
Great Plains Health, Diagnostic Imaging
North Platte, Nebraska, United States
XCancer
Omaha, Nebraska, United States
United Theranostics
Princeton, New Jersey, United States
Adaptive Research Inc.
Hawthorne, New York, United States
Queens Hospital Center
Jamaica, New York, United States
Columbia University Medical Center
New York, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
UNC Cancer Center
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Dayton Physicians Network / Greater Dayton Cancer Center
Kettering, Ohio, United States
VA Portland Health Care System
Portland, Oregon, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
The Urology Place
San Antonio, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States