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

NCT06235151 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CURCu64PSM0003
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 43

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

PSMA; Prostate Cancer; Initial Staging; Solar-Stage; Cu-64 PSMA; PET; Solar

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  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.

  4 Hours

• Specificity

  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.

  4 Hours

Secondary Outcomes (3)

• 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 in copper Cu 64 PSMA I&T injection

  At time of dose administration up to 72 Hours

• Positive Predictive Value and Negative Predictive Value

  4 hours

Other Outcomes (5)

• Determine the relationship of Prostate Specific Antigen (PSA) level, Gleason score, and the diagnostic performance of copper Cu 64 PSMA I&T PET/CT

  4 Hours

• Assess PPV of lesions on copper Cu 64 PSMA I&T PET/CT outside the prostate and pelvic lymph nodes (M1 disease)

  4 Hours

• Assess the impact of copper Cu 64 PSMA I&T PET/CT on the intended clinical management of study participants

  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 staging of prostate cancer.

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Curium US LLC: lead

Study Sites (43)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

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

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, 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 Hospital and Clinics - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

CIRA Health

Miami, Florida, 33165, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, 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

IU 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

United Theranostics

Glen Burnie, Maryland, 21061, United States

Location

VA Boston Healthcare System

Boston, Massachusetts, 02130, 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

Great Plains Health, Diagnostic Imaging

North Platte, Nebraska, 69101, United States

Location

XCancer

Omaha, Nebraska, 68130, United States

Location

United Theranostics

Princeton, New Jersey, 08540, United States

Location

Adaptive Research Inc.

Hawthorne, New York, 10532, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

UNC Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Dayton Physicians Network / Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, 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

The Urology Place

San Antonio, Texas, 78240, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, 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: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (43)