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 recurrent prostate cancer after radical prostatectomy or radiation therapy.
The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. 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 prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
235
Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.
Patient-Level Correct Detection Rate (CDR)
To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 minutes to 240 minutes post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.
Time frame: 4 hours
Region-Level Correct Localization Rate (CLR)
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 and 240 minutes post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.
Time frame: 4 hours
CDR and CLR by Prostate-Specific Antigen level
Comparison of patient level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT stratified by Prostate-Specific Antigen level.
Time frame: 4 hours
CDR and CLR by histopathology available and histopathology unavailable
Comparison of patient-level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT separated into subgroups of patients with histopathology available and unavailable.
Time frame: 4 hours
Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis
Reader kappa statistics of copper Cu 64 PSMA I\&T PET/CT scan interpretation by the blinded independent readers.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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 Miller School of Medicine
Miami, Florida, United States
...and 21 more locations
Time frame: 4 hours
Incidence of adverse events of copper Cu 64 PSMA I&T injection
Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: At time of dose administration up to 72 hours
Patient Level Detection Rate including subgroup analysis
Endpoint elevated from exploratory to secondary.
Time frame: 4 hours