Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Diagnostic Imaging with Copper Cu 64 PSMA I&T |
Copper Cu 64 PSMA I&T Injection |
|
Recruiting Locations
Little Rock, Arkansas 72211
Fullerton, California 92835
Los Angeles, California 90048
Los Angeles, California 90073
Newport Beach, California 92663
Orange, California 92868
San Francisco, California 94121
San Francisco, California 94158
Stanford, California 94305
Miami, Florida 33165
Sarasota, Florida 34239
Tampa, Florida 33615
Hines, Illinois 60141
Carmel, Indiana 46032
Iowa City, Iowa 52242
Kansas City, Kansas 66160
Glen Burnie, Maryland 21061
Minneapolis, Minnesota 55455
St Louis, Missouri 63104
North Platte, Nebraska 69101
Omaha, Nebraska 68130
Princeton, New Jersey 08540
Hawthorne, New York 10532
The Bronx, New York 10468
Cleveland, Ohio 44195
Kettering, Ohio 45409
Charleston, South Carolina 29425
Myrtle Beach, South Carolina 29572
Knoxville, Tennessee 37920
Houston, Texas 77042
San Antonio, Texas 78229
San Antonio, Texas 78240
Seattle, Washington 98109
More Details
- Status
- Recruiting
- Sponsor
- Curium US LLC
Detailed Description
The study will include approximately 439 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very 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.