Trial Title:
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
NCT ID:
NCT06235151
Condition:
Prostate Cancer
Prostate Adenocarcinoma
Conditions: Official terms:
Prostatic Neoplasms
Copper
Conditions: Keywords:
PSMA
Prostate Cancer
Initial Staging
Solar-Stage
Cu-64 PSMA
PET
Solar
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Copper Cu 64 PSMA I&T
Description:
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate
cancer.
Arm group label:
Diagnostic Imaging with Copper Cu 64 PSMA I&T
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.
Detailed description:
The study will include approximately 323 patients with newly diagnosed unfavorable
intermediate high-risk, high-risk or veru high-risk prostate cancer electing to undergo
radical prostatectomy with pelvic lymph node dissection. Each patient will be
administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I&T injection.
PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu
64 PSMA I&T injection.
The PET/CT images will be interpreted independently by three readers blinded to all
patient information. Each patient study will be assessed and scored for the detection of
lesions considered positive for Prostate Cancer (PC) in pelvic lymph nodes. Positive
lesions in the prostate, extra pelvic lymph nodes, bones and soft tissue/viscera will
also be recorded. Analysis of the reads will be used for determination of sensitivity and
specificity of copper Cu 64 PSMA I&T PET/CT by comparison to the reference standard of
histopathology after matching by hemipelvis with at least one true positive lesion
defining a true positive patient. Detection of PC outside the pelvis on the copper Cu 64
PSMA I&T PET/CT will be assessed using reference standard of histopathology and if not
available conventional imaging. Baseline conventional imaging will be reviewed for PC
disease or no disease by independent radiology readers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arkansas Urology
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Medical Foundation
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Facility:
Name:
Tower Urology
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Greater Los Angeles Healthcare System
Address:
City:
Los Angeles
Zip:
90073
Country:
United States
Status:
Recruiting
Facility:
Name:
Hoag Memorial Hospital Presbyterian
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
San Francisco VA Medical Center
Address:
City:
San Francisco
Zip:
94121
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Saint John's Health Center
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Hospital & Clinics
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgetown University Medical Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
CIRA Health
Address:
City:
Miami
Zip:
33165
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarasota Memorial Health Care System
Address:
City:
Sarasota
Zip:
34239
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Urology Partners
Address:
City:
Tampa
Zip:
33615
Country:
United States
Status:
Recruiting
Facility:
Name:
Edward Hines Jr. VA Hospital
Address:
City:
Hines
Zip:
60141
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology of Indiana, LLC
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Facility:
Name:
IU Health Neuroscience Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Kansas Hospital
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Boston Healthcare System
Address:
City:
Boston
Zip:
02130
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
M Health Fairview University of Minnesota Medical Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Facility:
Name:
SSM Health Saint Louis University Hospital
Address:
City:
Saint Louis
Zip:
63104
Country:
United States
Status:
Recruiting
Facility:
Name:
John Cochran VA Medical Center
Address:
City:
Saint Louis
Zip:
63106
Country:
United States
Status:
Recruiting
Facility:
Name:
Great Plains Health, Diagnostic Imaging
Address:
City:
North Platte
Zip:
69101
Country:
United States
Status:
Recruiting
Facility:
Name:
XCancer
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Facility:
Name:
Adaptive Research Inc.
Address:
City:
Hawthorne
Zip:
10532
Country:
United States
Status:
Recruiting
Facility:
Name:
Queens Hospital Center
Address:
City:
Jamaica
Zip:
11432
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Portland Health Care System
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina Urologic Research Center, LLC
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
Excel Diagnostics and Nuclear Oncology Center
Address:
City:
Houston
Zip:
77042
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
The Urology Place
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Status:
Recruiting
Start date:
April 1, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Curium US LLC
Agency class:
Industry
Source:
Curium US LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06235151
