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

NCT06235099 | Completed Phase 3 FDA Drug

• 1 other identifier: CURCu64PSM0002
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 31

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.

Conditions

Prostate Adenocarcinoma; Biochemical Recurrence of Malignant Neoplasm of Prostate; Prostate Cancer

Keywords

PSMA; Prostate Cancer; BCR; Solar-Recur; Cu-64 PSMA; PET; Solar

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 hours

Secondary Outcomes (5)

• CDR and CLR by Prostate-Specific Antigen level

  4 hours

• CDR and CLR by histopathology available and histopathology unavailable

  4 hours

• Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis

  4 hours

• Incidence of adverse events of copper Cu 64 PSMA I&T injection

  At time of dose administration up to 72 hours

• Patient Level Detection Rate including subgroup analysis

  4 hours

Study Arms (1)

Diagnostic imaging with Copper Cu 64 PSMA I&T

EXPERIMENTAL

Copper Cu 64 PSMA I\&T Injection

Drug: Copper Cu 64 PSMA I&T

Interventions

Copper Cu 64 PSMA I&T DRUG

Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

Diagnostic imaging with Copper Cu 64 PSMA I&T

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Curium US LLC: lead

Study Sites (31)

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

Location

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Edward Hines Jr VA Hospital

Hines, Illinois, 60141, United States

Location

Urology of Indiana, LLC

Carmel, Indiana, 46032, United States

Location

Indiana University Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63104, United States

Location

John Cochran VA Medical Center

St Louis, Missouri, 63106, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Great Plains Health, Diagnostic Imaging

North Platte, Nebraska, 69101, United States

Location

XCancer

Omaha, Nebraska, 68130, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, 77042, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: April 1, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)