Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer (Solar-Stage)

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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Estimated): 439
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hassan El Gazri; Phone Number: +33 7 69 28 53 40; Email: SOLAR@curiumpharma.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Urology
  • California
    • Fullerton, California, United States, 92835
      • Recruiting
      • Providence Medical Foundation
    • 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
    • Orange, California, United States, 92868
      • Recruiting
      • University of California, Irvine
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Helen Diller Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94121
      • Recruiting
      • San Francisco VA Medical Center
    • Santa Monica, California, United States, 90404
      • Completed
      • Providence Saint John's Health Center
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Hospital & Clinics
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Completed
      • Georgetown University Medical Center
  • Florida
    • Miami, Florida, United States, 33165
      • Recruiting
      • CIRA Health
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Health Care System
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Florida Urology Partners
  • Illinois
    • Hines, Illinois, United States, 60141
      • Recruiting
      • Edward Hines Jr. VA Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • Urology of Indiana, LLC
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • IU Health Neuroscience Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Hospital
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Recruiting
      • United Theranostics
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Completed
      • VA Boston Healthcare System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • M Health Fairview University of Minnesota Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63104
      • Recruiting
      • SSM Health Saint Louis University Hospital
    • St Louis, Missouri, United States, 63106
      • Completed
      • John Cochran VA Medical Center
  • Nebraska
    • North Platte, Nebraska, United States, 69101
      • Recruiting
      • Great Plains Health, Diagnostic Imaging
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Xcancer
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Recruiting
      • United Theranostics
  • New York
    • Hawthorne, New York, United States, 10532
      • Recruiting
      • Adaptive Research Inc.
    • Jamaica, New York, United States, 11432
      • Withdrawn
      • Queens Hospital Center
    • New York, New York, United States, 10032
      • Completed
      • Columbia University Medical Center
    • The Bronx, New York, United States, 10468
      • Recruiting
      • James J. Peters VA Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Completed
      • UNC Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
    • Kettering, Ohio, United States, 45409
      • Recruiting
      • Dayton Physicians Network / Greater Dayton Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Completed
      • VA Portland Health Care System
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Hollings Cancer Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center, LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee 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
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • The Urology Place
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

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 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 staging of prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.	4 Hours
Specificity	Determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.	4 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 in 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the relationship of Prostate Specific Antigen (PSA) level, Gleason score, and the diagnostic performance of copper Cu 64 PSMA I&T PET/CT	Correlation of sensitivity, specificity, detection rate, and Positive Predictive Value (PPV) to baseline PSA and unfavorable intermediate-risk, high-risk or very high-risk at the time of prostatectomy.	4 Hours
Assess PPV of lesions on copper Cu 64 PSMA I&T PET/CT outside the prostate and pelvic lymph nodes (M1 disease)	Proportion of patients with M1 lesions on copper Cu 64 PSMA I&T PET/CT subsequently confirmed to be TP by biopsy, surgery and confirmatory imaging.	4 Hours
Assess the impact of copper Cu 64 PSMA I&T PET/CT on the intended clinical management of study participants	Percentage of patients in whom the copper Cu 64 PSMA I&T PET/CT changed the intended patient management (major and other changes).	4 Hours
Assess the detection rate on patient level and split by pelvic lymph nodes and extra pelvic lesions	Patient level positivity rates of copper Cu 64 PSMA I&T split by pelvic lymph nodes and extra pelvic lesions.	4 Hours
Determine sensitivity and specificity by risk group (unfavorable intermediate, high, or very high risk)	Determine the diagnostic performance of copper Cu 64 PSMA I&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients by risk group (unfavorable intermediate, high, or very high risk).	4 Hours

Collaborators and Investigators

• Sponsor: Curium US LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

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 (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PET; Prostate Cancer; PSMA; Cu-64 PSMA; Solar; Initial Staging; Solar-Stage
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• Other Study ID Numbers: CURCu64PSM0003

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