NCT06235151

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 439 (estimated)
• Sponsor: Curium US LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Copper Cu 64 PSMA I&T	Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-01-31
• Last updated: 2026-04-08

Locations

43 sites across 1 country: United States

Regulatory

• FDA-regulated drug study