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

Phase 3

Recruiting

• Conditions: Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Drug: Copper Cu 64 PSMA I&T

• 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.

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-31
• Study Start: 2024-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 323

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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