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
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.
Detailed description
The study will include approximately 439 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection. 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 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.
Arms & interventions
- DrugCopper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Outcome measures
Primary
Sensitivity
Determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.
Time frame: 4 Hours
Specificity
Determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.
Time frame: 4 Hours
Secondary
Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis
Time frame: 4 Hours
Incidence of adverse events in copper Cu 64 PSMA I&T injection
Time frame: At time of dose administration up to 72 Hours
Positive Predictive Value and Negative Predictive Value
Time frame: 4 hours
Eligibility criteria
Study locations (44)
Urology Centers of Alabama
Homewood, Alabama, 35209
Arkansas Urology
Little Rock, Arkansas, 72211
Providence Medical Foundation
Fullerton, California, 92835
Tower Urology
Los Angeles, California, 90048
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of California, Irvine
Orange, California, 92868
San Francisco VA Medical Center
San Francisco, California, 94121
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Providence Saint John's Health Center
Santa Monica, California, 90404
Stanford Hospital & Clinics
Stanford, California, 94305
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
CIRA Health
Miami, Florida, 33165
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Florida Urology Partners
Tampa, Florida, 33615
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
Urology of Indiana, LLC
Carmel, Indiana, 46032
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
The University of Kansas Hospital
Kansas City, Kansas, 66160
United Theranostics
Glen Burnie, Maryland, 21061
VA Boston Healthcare System
Boston, Massachusetts, 02130
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104
John Cochran VA Medical Center
St Louis, Missouri, 63106
Great Plains Health, Diagnostic Imaging
North Platte, Nebraska, 69101
XCancer
Omaha, Nebraska, 68130
United Theranostics
Princeton, New Jersey, 08540
Adaptive Research Inc.
Hawthorne, New York, 10532
Queens Hospital Center
Jamaica, New York, 11432
Columbia University Medical Center
New York, New York, 10032
James J. Peters VA Medical Center
The Bronx, New York, 10468
UNC Cancer Center
Chapel Hill, North Carolina, 27514
Cleveland Clinic
Cleveland, Ohio, 44195
Dayton Physicians Network / Greater Dayton Cancer Center
Kettering, Ohio, 45409
VA Portland Health Care System
Portland, Oregon, 97239
Hollings Cancer Center
Charleston, South Carolina, 29425
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042
Urology San Antonio
San Antonio, Texas, 78229
The Urology Place
San Antonio, Texas, 78240
Fred Hutchinson Cancer Center
Seatle, Washington, 98109