Actively Recruiting
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
Eligibility Criteria
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
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
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
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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