Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

Phase 3

Active, not recruiting

• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Biochemical Recurrence of Malignant Neoplasm of Prostate
• Interventions: Drug: Copper Cu 64 PSMA I&T

• Registration Number: NCT06235099
• 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 recurrent prostate cancer after radical prostatectomy or radiation therapy.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

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: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 235

Inclusion Criteria

• Patients with histologically proven prostate adenocarcinoma.

• Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.

• Recurrence of disease defined as:

  1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or
  2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.

• Male aged greater than or equal to 18 years.

• Able to understand and provide signed written informed consent.

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Exclusion Criteria

• Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.
• 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 scan) 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.

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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
Patient-Level Correct Detection Rate (CDR)	4 hours	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.
Region-Level Correct Localization Rate (CLR)	4 hours	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.

Secondary Outcome Measures

Name	Time	Method
CDR and CLR by Prostate-Specific Antigen level	4 hours	Comparison of patient level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT stratified by Prostate-Specific Antigen level.
CDR and CLR by histopathology available and histopathology unavailable	4 hours	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.
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.
Incidence of adverse events of 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.

Trial Locations

Locations (31)

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 Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Biogenix Molecular, LLC; 🇺🇸 Miami, 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

Indiana University 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

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

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Great Plains Health, Diagnostic Imaging; 🇺🇸 North Platte, Nebraska, United States

XCancer; 🇺🇸 Omaha, Nebraska, United States

James J. Peters VA Medical Center; 🇺🇸 Bronx, New York, United States

Queens Hospital Center; 🇺🇸 Jamaica, 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