NCT05653856

Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer

A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Curium US LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.

Detailed description

The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 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 in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. Analysis of the reads will be used for determination of the CLR and CDR for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I\&T PET/CT by comparison to the Composite Reference Standard.

Conditions

• Metastasis From Malignant Tumor of Prostate (Disorder)

Interventions

Type	Name	Description
DRUG	64Cu-PSMA I&T	Radiolabeled Receptor-Targeted Diagnostic Product

Timeline

• Start date: 2022-12-05
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2022-12-16
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study