RecruitingPhase 3NCT06235151

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

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

Sponsor

Curium US LLC

Enrollment

439 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Prostate Adenocarcinoma

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new PET scan imaging agent (Copper Cu 64 PSMA I&T) for staging prostate cancer before surgery, to help determine whether cancer has spread to nearby lymph nodes. **You may be eligible if...** - You are male and 18 or older - You have been diagnosed with prostate cancer (confirmed by biopsy) - You are planning to have prostate removal surgery with lymph node dissection - Your cancer is classified as unfavorable intermediate-risk, high-risk, or very high-risk **You may NOT be eligible if...** - You have already received hormone therapy, chemotherapy, or radiation for prostate cancer before surgery - You have participated in another clinical trial within the last 30 days - You have a known allergy to the imaging agent being tested - You have had recent X-ray contrast or other PET scans within certain timeframes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCopper 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

View Full Details on ClinicalTrials.gov

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NCT06235151

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