Clinical trial NCT06235151: Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Official title: Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: PSMA
Prostate Cancer
Initial Staging
Solar-Stage
Cu-64 PSMA
PET
Solar
Lead sponsor: Curium US LLC
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 323
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: Sensitivity
timeFrame: 4 Hours
measure: Specificity
timeFrame: 4 Hours
Secondary outcomes:
measure: Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis
timeFrame: 4 Hours
measure: Incidence of adverse events in copper Cu 64 PSMA I&T injection
timeFrame: At time of dose administration up to 72 Hours
Other outcomes:
measure: Determine the relationship of Prostate Specific Antigen (PSA) level, Gleason score, and the diagnostic performance of copper Cu 64 PSMA I&T PET/CT
timeFrame: 4 Hours
measure: Assess PPV of lesions on copper Cu 64 PSMA I&T PET/CT outside the prostate and pelvic lymph nodes (M1 disease)
timeFrame: 4 Hours
measure: Assess the impact of copper Cu 64 PSMA I&T PET/CT on the intended clinical management of study participants
timeFrame: 4 Hours
measure: Assess the detection rate on patient level and split by pelvic lymph nodes and extra pelvic lesions
timeFrame: 4 Hours
measure: Determine sensitivity and specificity by risk group (unfavorable intermediate, high, or very high risk)
timeFrame: 4 Hours
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: CIRA Health
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Neuroscience Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: John Cochran VA Medical Center
state: Missouri
city: North Platte
country: United States
facility: Great Plains Health, Diagnostic Imaging
state: Nebraska
city: Omaha
country: United States
facility: XCancer
state: Nebraska
city: Hawthorne
country: United States
facility: Adaptive Research Inc.
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center, LLC
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: Excel Diagnostics and Nuclear Oncology Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
References: