Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06235151

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

Led by Curium US LLC · Updated on 2026-04-08

439

Participants Needed

43

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Histologically confirmed prostate adenocarcinoma
  • Planned radical prostatectomy with pelvic lymph node dissection
  • Unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer as defined by NCCN Guidelines
  • Able to understand and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Prior androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy, or investigational therapy for prostate cancer before prostatectomy
  • Participation in an interventional clinical trial within 30 days with investigational product use within five biological half-lives prior to administration
  • Any medical condition or circumstance that may compromise study data or participation
  • Planned x-ray contrast within 24 hours or PET radiotracer within 10 physical half-lives before PET scan; barium contrast must be cleared before PET scan
  • Administration of high energy gamma emitting radioisotopes within five physical half-lives prior to copper Cu 64 PSMA I&T
  • Known hypersensitivity to the active substance or any excipients
  • PSMA PET scan as part of standard care within 90 days prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 43 locations

1

Arkansas Urology

Little Rock, Arkansas, United States, 72211

Actively Recruiting

2

Providence Medical Foundation

Fullerton, California, United States, 92835

Actively Recruiting

3

Tower Urology

Los Angeles, California, United States, 90048

Actively Recruiting

4

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States, 90073

Actively Recruiting

5

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

6

University of California, Irvine

Orange, California, United States, 92868

Actively Recruiting

7

San Francisco VA Medical Center

San Francisco, California, United States, 94121

Actively Recruiting

8

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94158

Actively Recruiting

9

Providence Saint John's Health Center

Santa Monica, California, United States, 90404

Completed

10

Stanford Hospital & Clinics

Stanford, California, United States, 94305

Actively Recruiting

11

Georgetown University Medical Center

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

Completed

12

University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Not Yet Recruiting

13

CIRA Health

Miami, Florida, United States, 33165

Actively Recruiting

14

Sarasota Memorial Health Care System

Sarasota, Florida, United States, 34239

Actively Recruiting

15

Florida Urology Partners

Tampa, Florida, United States, 33615

Actively Recruiting

16

Edward Hines Jr. VA Hospital

Hines, Illinois, United States, 60141

Actively Recruiting

17

Urology of Indiana, LLC

Carmel, Indiana, United States, 46032

Actively Recruiting

18

IU Health Neuroscience Center

Indianapolis, Indiana, United States, 46202

Completed

19

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

20

The University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Actively Recruiting

21

United Theranostics

Glen Burnie, Maryland, United States, 21061

Actively Recruiting

22

VA Boston Healthcare System

Boston, Massachusetts, United States, 02130

Completed

23

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

24

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States, 63104

Actively Recruiting

25

John Cochran VA Medical Center

St Louis, Missouri, United States, 63106

Completed

26

Great Plains Health, Diagnostic Imaging

North Platte, Nebraska, United States, 69101

Actively Recruiting

27

XCancer

Omaha, Nebraska, United States, 68130

Actively Recruiting

28

United Theranostics

Princeton, New Jersey, United States, 08540

Actively Recruiting

29

Adaptive Research Inc.

Hawthorne, New York, United States, 10532

Actively Recruiting

30

Queens Hospital Center

Jamaica, New York, United States, 11432

Withdrawn

31

Columbia University Medical Center

New York, New York, United States, 10032

Completed

32

James J. Peters VA Medical Center

The Bronx, New York, United States, 10468

Actively Recruiting

33

UNC Cancer Center

Chapel Hill, North Carolina, United States, 27514

Completed

34

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

35

Dayton Physicians Network / Greater Dayton Cancer Center

Kettering, Ohio, United States, 45409

Actively Recruiting

36

VA Portland Health Care System

Portland, Oregon, United States, 97239

Completed

37

Hollings Cancer Center

Charleston, South Carolina, United States, 29425

Actively Recruiting

38

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

39

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Actively Recruiting

40

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, United States, 77042

Actively Recruiting

41

Urology San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

42

The Urology Place

San Antonio, Texas, United States, 78240

Actively Recruiting

43

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

H

Hassan El Gazri

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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