Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer (Solar-Recur)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Biochemical Recurrence of Malignant Neoplasm of Prostate
• Intervention / Treatment: Drug: Copper Cu 64 PSMA I&T

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Darcy Denner, PhD; Phone Number: 314-600-4844; Email: SOLAR@curiumpharma.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • Recruiting
      • VA Greater Los Angeles Healthcare System
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Tower Urology
    • Newport Beach, California, United States, 92663
      • Recruiting
      • HOAG Memorial Hospital Presbyterian
  • Florida
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Florida Urology Partners
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health Neuroscience Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • Nebraska
    • North Platte, Nebraska, United States, 69101
      • Recruiting
      • Great Plains Health, Diagnostic Imaging
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • XCancer
  • New York
    • Bronx, New York, United States, 10468
      • Recruiting
      • James J. Peters VA Medical Center
  • Texas
    • Houston, Texas, United States, 77042
      • Recruiting
      • Excel Diagnostics and Nuclear Oncology Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic imaging with Copper Cu 64 PSMA I&T; Copper Cu 64 PSMA I&T Injection	Drug: Copper Cu 64 PSMA I&T; Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Curium US LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PET; Prostate Cancer; PSMA; BCR; Cu-64 PSMA; Solar-Recur; Solar
• Additional Relevant MeSH Terms: Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms; Prostatic Neoplasms; Recurrence; Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• Other Study ID Numbers: CURCu64PSM0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No