NCT06235099

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• 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 recurrent prostate cancer after radical prostatectomy or radiation therapy.

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.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma
• Biochemical Recurrence of Malignant Neoplasm of Prostate

Interventions

Type	Name	Description
DRUG	Copper Cu 64 PSMA I&T	Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2024-01-31
• Last updated: 2026-02-18

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study