Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
- Conditions
- Prostate AdenocarcinomaProstate Cancer
- Interventions
- Registration Number
- NCT06235151
- Lead Sponsor
- Curium US LLC
- Brief 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 323 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or veru 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 323
- 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.
- Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic Imaging with Copper Cu 64 PSMA I&T Copper Cu 64 PSMA I&T Copper Cu 64 PSMA I\&T Injection
- Primary Outcome Measures
Name Time Method Sensitivity 4 Hours 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.
Specificity 4 Hours 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.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events in copper Cu 64 PSMA I&T injection At time of dose administration up to 72 Hours 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.
Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis 4 Hours Reader kappa statistics of copper Cu 64 PSMA I\&T PET/CT scan interpretation by the blinded independent readers.
Related Research Topics
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Trial Locations
- Locations (76)
UNC Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
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
Providence Saint John's Health Center
🇺🇸Santa Monica, California, United States
Stanford Hospital & Clinics
🇺🇸Stanford, California, United States
Georgetown University Medical Center
🇺🇸Washington, 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
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
🇺🇸Saint Louis, Missouri, United States
John Cochran VA Medical Center
🇺🇸Saint Louis, Missouri, United States
Great Plains Health, Diagnostic Imaging
🇺🇸North Platte, Nebraska, United States
XCancer
🇺🇸Omaha, Nebraska, 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
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
VA Portland Health Care System
🇺🇸Portland, Oregon, 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
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
Providence Saint John's Health Center
🇺🇸Santa Monica, California, United States
Stanford Hospital & Clinics
🇺🇸Stanford, California, United States
Georgetown University Medical Center
🇺🇸Washington, 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
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
🇺🇸Saint Louis, Missouri, United States
John Cochran VA Medical Center
🇺🇸Saint Louis, Missouri, United States
Great Plains Health, Diagnostic Imaging
🇺🇸North Platte, Nebraska, United States
XCancer
🇺🇸Omaha, Nebraska, 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
UNC Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Cleveland Clinic
🇺🇸Cleveland, 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
Excel Diagnostics and Nuclear Oncology Center
🇺🇸Houston, Texas, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
The Urology Place
🇺🇸San Antonio, Texas, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States