Phase 3 Multi-Center Open-label Study of Copper Cu 64 PSMA IT PETCT for Staging Men With Newly Diagnosed High-risk Prostate Cancer Undergoing Radical Prostatectomy with Pelvic Lymph Node Dissection

What this Trial Is About

Researchers are evaluating copper Cu 64 PSMA IT injection as a PETCT imaging tracer in men newly diagnosed with unfavorable intermediate high-risk, high-risk, or very high-risk prostate cancer. This Phase 3, open-label study aims to assess the diagnostic accuracy of this imaging method in staging prostate cancer before surgery. The study involves patients who are planning to undergo radical prostatectomy with pelvic lymph node dissection. Participants will receive an intravenous dose of approximately 8 mCi of copper Cu 64 PSMA IT. PETCT scans will be performed between 1 to 4 hours after the injection. The images will be independently reviewed by three experts who will identify and score lesions positive for prostate cancer in the pelvic lymph nodes, prostate, extra pelvic lymph nodes, bones, and soft tissues. The imaging results will be compared to findings from histopathology and conventional imaging to determine sensitivity and specificity. During the study, patients will undergo PETCT imaging and their scans will be carefully analyzed to evaluate the detection of cancer lesions. Researchers will monitor safety by tracking any adverse events up to 72 hours after the injection. The primary measures include sensitivity and specificity of the imaging at 4 hours post-injection. Additional assessments include agreement among image readers and predictive values. The study is expected to last until September 2026.

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