Clinical trial NCT06235099: Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
Official title: A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Biochemical Recurrence of Malignant Neoplasm of Prostate
Keywords: PSMA
Prostate Cancer
BCR
Solar-Recur
Cu-64 PSMA
PET
Solar
Lead sponsor: Curium US LLC
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 235
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 recurrent prostate cancer after radical prostatectomy or radiation therapy.

Detailed description: The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. 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 prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven prostate adenocarcinoma.
* Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.
* Recurrence of disease defined as:

  1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or
  2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.
* Male aged greater than or equal to 18 years.
* Able to understand and provide signed written informed consent.

Exclusion Criteria:

* Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.
* 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 scan) 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: Patient-Level Correct Detection Rate (CDR)
timeFrame: 4 hours
measure: Region-Level Correct Localization Rate (CLR)
timeFrame: 4 hours
Secondary outcomes:
measure: CDR and CLR by Prostate-Specific Antigen level
timeFrame: 4 hours
measure: CDR and CLR by histopathology available and histopathology unavailable
timeFrame: 4 hours
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 of copper Cu 64 PSMA I&T injection
timeFrame: At time of dose administration up to 72 hours
Other outcomes:
Locations:
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 Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Biogenix Molecular, LLC
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: Indiana University 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: 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: Saint Louis
country: United States
facility: Washington University School of Medicine
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: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
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
Study officials:
References: