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
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with histologically proven prostate adenocarcinoma.
• 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.
Locations
United States
Arkansas
Arkansas Urology
RECRUITING
Little Rock
California
Providence Medical Foundation
RECRUITING
Fullerton
Tower Urology
RECRUITING
Los Angeles
VA Greater Los Angeles Healthcare System
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
University of California, Irvine
RECRUITING
Orange
San Francisco VA Medical Center
RECRUITING
San Francisco
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
Providence Saint John's Health Center
COMPLETED
Santa Monica
Stanford Hospital & Clinics
RECRUITING
Stanford
Washington, D.c.
Georgetown University Medical Center
COMPLETED
Washington D.c.
Florida
CIRA Health
RECRUITING
Miami
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
NOT_YET_RECRUITING
Miami
Sarasota Memorial Health Care System
RECRUITING
Sarasota
Florida Urology Partners
RECRUITING
Tampa
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Edward Hines Jr. VA Hospital
RECRUITING
Hines
Indiana
Urology of Indiana, LLC
RECRUITING
Carmel
IU Health Neuroscience Center
COMPLETED
Indianapolis
Kansas
The University of Kansas Hospital
RECRUITING
Kansas City
Massachusetts
VA Boston Healthcare System
COMPLETED
Boston
Maryland
United Theranostics
RECRUITING
Glen Burnie
Minnesota
M Health Fairview University of Minnesota Medical Center
RECRUITING
Minneapolis
Missouri
John Cochran VA Medical Center
RECRUITING
St Louis
SSM Health Saint Louis University Hospital
RECRUITING
St Louis
North Carolina
UNC Cancer Center
COMPLETED
Chapel Hill
Nebraska
Great Plains Health, Diagnostic Imaging
RECRUITING
North Platte
XCancer
RECRUITING
Omaha
New Jersey
United Theranostics
RECRUITING
Princeton
New York
Adaptive Research Inc.
RECRUITING
Hawthorne
Queens Hospital Center
WITHDRAWN
Jamaica
Columbia University Medical Center
COMPLETED
New York
James J. Peters VA Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Dayton Physicians Network / Greater Dayton Cancer Center
RECRUITING
Kettering
Oregon
VA Portland Health Care System
COMPLETED
Portland
South Carolina
Hollings Cancer Center
RECRUITING
Charleston
Carolina Urologic Research Center, LLC
RECRUITING
Myrtle Beach
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
Excel Diagnostics and Nuclear Oncology Center
RECRUITING
Houston
The Urology Place
RECRUITING
San Antonio
Urology San Antonio
RECRUITING
San Antonio
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
Hassan El Gazri
SOLAR@curiumpharma.com
+33 7 69 28 53 40
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 323
Treatments
Experimental: Diagnostic Imaging with Copper Cu 64 PSMA I&T
Copper Cu 64 PSMA I\&T Injection
Related Therapeutic Areas
Sponsors
Leads: Curium US LLC