Clinical trials

Solar-Stage: A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of 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

ClinicalTrials.gov identifier

NCT06235151

Interventions

Intervention Type: Drug
Intervention Name: Copper Cu64 PSMA I&T
Intervention Description: Intravenous radionuclide used for PET imaging

Curium Protocol Number

CURCu64PSM0003

Phase

Phase III

Trial Status

Enrollment is Open

Protocol Title

A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of 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

Purpose

The purpose of this study is to evaluate the safety, biodistribution, and image quality of Copper Cu64 PSMA I&T Injection to detect metastatic prostate cancer in PET imaging.