Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Prostate Cancer Clinical Trial

— Solar-Stage  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235151
• Other study ID #: CURCu64PSM0003
• 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: 314-660-4844
• 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 newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 323
• 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.
• 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 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.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Copper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital	Hines	Illinois
United States	Excel Diagnostics and Nuclear Oncology Center	Houston	Texas
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	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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 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