Actively Recruiting
Phase 3 Multi-Center Open-label Study of Copper Cu 64 PSMA I&T PET/CT for Staging Men With Newly Diagnosed High-risk Prostate Cancer Undergoing Radical Prostatectomy with Pelvic Lymph Node Dissection
Led by Curium US LLC · Updated on 2026-06-04
439
Participants Needed
44
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating copper Cu 64 PSMA I&T injection as a PET/CT imaging tracer in men newly diagnosed with unfavorable intermediate high-risk, high-risk, or very high-risk prostate cancer. This Phase 3, open-label study aims to assess the diagnostic accuracy of this imaging method in staging prostate cancer before surgery. The study involves patients who are planning to undergo radical prostatectomy with pelvic lymph node dissection. Participants will receive an intravenous dose of approximately 8 mCi of copper Cu 64 PSMA I&T. PET/CT scans will be performed between 1 to 4 hours after the injection. The images will be independently reviewed by three experts who will identify and score lesions positive for prostate cancer in the pelvic lymph nodes, prostate, extra pelvic lymph nodes, bones, and soft tissues. The imaging results will be compared to findings from histopathology and conventional imaging to determine sensitivity and specificity. During the study, patients will undergo PET/CT imaging and their scans will be carefully analyzed to evaluate the detection of cancer lesions. Researchers will monitor safety by tracking any adverse events up to 72 hours after the injection. The primary measures include sensitivity and specificity of the imaging at 4 hours post-injection. Additional assessments include agreement among image readers and predictive values. The study is expected to last until September 2026.
CONDITIONS
Brief 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...
- Patients with histologically proven prostate adenocarcinoma
- Planned prostatectomy with pelvic lymph node dissection
- Unfavorable intermediate-risk, high-risk, or very high-risk disease as defined by NCCN Guidelines
- Male aged 18 years or older
- 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 another interventional clinical trial within 30 days and received investigational product within five biological half-lives
- Any medical condition or circumstance that may affect data quality or study compliance
- Planned x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives before PET scan
- Administration of high energy gamma-emitting radioisotopes within five physical half-lives before copper Cu 64 PSMA I&T injection
- Known hypersensitivity to the active substance or excipients of the investigational product
- Previous 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous injection of Copper Cu 64 PSMA I&T followed by PET/CT imaging to detect prostate cancer lesions.
1 imaging visit (in-person) occurring 1 to 4 hours after injection
Duration - Up to 1 week
Participants undergo radical prostatectomy with pelvic lymph node dissection following imaging.
Approximately 1 to 2 post-operative visits
Duration - Up to 72 hours post dose administration
Participants are monitored for outcomes including lesion detection accuracy and adverse events up to 72 hours after injection.
Follow-up assessments may occur during this period
Trial Site Locations
Total: 44 locations
1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
Actively Recruiting
2
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
4
Tower Urology
Los Angeles, California, United States, 90048
Actively Recruiting
5
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
6
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
7
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
8
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Actively Recruiting
9
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
10
Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Completed
11
Stanford Hospital & Clinics
Stanford, California, United States, 94305
Actively Recruiting
12
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Completed
13
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Not Yet Recruiting
14
CIRA Health
Miami, Florida, United States, 33165
Actively Recruiting
15
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
16
Florida Urology Partners
Tampa, Florida, United States, 33615
Actively Recruiting
17
Edward Hines Jr. VA Hospital
Hines, Illinois, United States, 60141
Actively Recruiting
18
Urology of Indiana, LLC
Carmel, Indiana, United States, 46032
Actively Recruiting
19
IU Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
Completed
20
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
21
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
22
United Theranostics
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
23
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Completed
24
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
25
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
26
John Cochran VA Medical Center
St Louis, Missouri, United States, 63106
Completed
27
Great Plains Health, Diagnostic Imaging
North Platte, Nebraska, United States, 69101
Actively Recruiting
28
XCancer
Omaha, Nebraska, United States, 68130
Actively Recruiting
29
United Theranostics
Princeton, New Jersey, United States, 08540
Actively Recruiting
30
Adaptive Research Inc.
Hawthorne, New York, United States, 10532
Actively Recruiting
31
Queens Hospital Center
Jamaica, New York, United States, 11432
Withdrawn
32
Columbia University Medical Center
New York, New York, United States, 10032
Completed
33
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
34
UNC Cancer Center
Chapel Hill, North Carolina, United States, 27514
Completed
35
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
36
Dayton Physicians Network / Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
Actively Recruiting
37
VA Portland Health Care System
Portland, Oregon, United States, 97239
Completed
38
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
39
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
40
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
41
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
Actively Recruiting
42
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
43
The Urology Place
San Antonio, Texas, United States, 78240
Actively Recruiting
44
Fred Hutchinson Cancer Center
Seatle, Washington, United States, 98109
Actively Recruiting
Research Team
H
Hassan El Gazri
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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