Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
NCT ID: NCT06235151
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
323 participants
INTERVENTIONAL
2024-04-01
2026-03-31
Brief Summary
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Detailed Description
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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 lesions considered positive for Prostate Cancer (PC) in pelvic lymph nodes. Positive lesions in the prostate, extra pelvic lymph nodes, bones and soft tissue/viscera will also be recorded. Analysis of the reads will be used for determination of sensitivity and specificity of copper Cu 64 PSMA I\&T PET/CT by comparison to the reference standard of histopathology after matching by hemipelvis with at least one true positive lesion defining a true positive patient. Detection of PC outside the pelvis on the copper Cu 64 PSMA I\&T PET/CT will be assessed using reference standard of histopathology and if not available conventional imaging. Baseline conventional imaging will be reviewed for PC disease or no disease by independent radiology readers.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic Imaging with Copper Cu 64 PSMA I&T
Copper Cu 64 PSMA I\&T Injection
Copper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Interventions
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Copper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Curium US LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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CURCu64PSM0003
Identifier Type: -
Identifier Source: org_study_id
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