Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

Prostate Cancer Clinical Trial

— Solar-Recur  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235099
• Other study ID #: CURCu64PSM0002
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Curium US LLC
• Contact: Darcy Denner, PhD
• Phone: 314-600-4844
• Email: SOLAR[@]curiumpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 0.2 ng/mL followed by subsequent confirmatory PSA value greater than 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 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.

Related Conditions & MeSH terms

• Neoplasms
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Drug:
• Copper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York
United States	Excel Diagnostics and Nuclear Oncology Center	Houston	Texas
United States	Indiana University Health Neuroscience Center	Indianapolis	Indiana
United States	Tower Urology	Los Angeles	California
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Great Plains Health, Diagnostic Imaging	North Platte	Nebraska
United States	XCancer	Omaha	Nebraska
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Urology San Antonio	San Antonio	Texas
United States	Florida Urology Partners	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Curium US LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Level Correct Detection Rate (CDR)	To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 minutes to 240 minutes post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.	4 hours
Primary	Region-Level Correct Localization Rate (CLR)	To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 and 240 minutes post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.	4 hours
Secondary	CDR and CLR by Prostate-Specific Antigen level	Comparison of patient level CDR and region level CLR of copper Cu 64 PSMA I&T PET/CT stratified by Prostate-Specific Antigen level.	4 hours
Secondary	CDR and CLR by histopathology available and histopathology unavailable	Comparison of patient-level CDR and region level CLR of copper Cu 64 PSMA I&T PET/CT separated into subgroups of patients with histopathology available and unavailable.	4 hours
Secondary	Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis	Reader kappa statistics of copper Cu 64 PSMA I&T PET/CT scan interpretation by the blinded independent readers.	4 hours
Secondary	Incidence of adverse events of copper Cu 64 PSMA I&T injection	Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	At time of dose administration up to 72 hours