Phase 2 Study of Safety and Diagnostic Accuracy of uPAR PET Imaging to Assess Prostate Cancer Aggressiveness in Men with Localized, Untreated Prostate Cancer

What this Trial Is About

Researchers are investigating a new diagnostic PET imaging agent called 64Cu-DOTA-AE105 to assess the aggressiveness of low-risk, localized prostate cancer without the need for repeated biopsies. This phase 2 trial focuses on patients with untreated prostate cancer verified by biopsy, aiming to see if the imaging agent can accurately classify cancer severity based on ISUP grades. The study is sponsored by Curasight and seeks to provide a less invasive method for monitoring prostate cancer progression. The trial is divided into two parts. In Part 1, participants receive two injections of the test drug on two separate days Day 1 and Day 8, followed by PETCT scans to capture images of the prostate. Dose groups include 100 MBq, 150 MBq, and 200 MBq of 64Cu-DOTA-AE105. Part 2 involves a larger group receiving a single injection of 200 MBq of the test drug with subsequent PETCT scanning. Before and after injections, participants undergo health evaluations including ECG, blood, and urine tests. Participants will be involved in imaging sessions on specified days with health monitoring before and after each scan. Researchers will measure the maximum standard uptake value SUVmax of the imaging agent at various time points post-injection to assess tumor visibility and consistency. Additional blood and urine samples will be analyzed to monitor drug distribution and elimination. Safety and diagnostic performance are evaluated throughout, with the entire study lasting until January 2027.

Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer