Exploring the Distribution of 99mTc-PSMA-I&S in Men Undergoing Surgery for Prostate Cancer Using Imaging and Histopathology for Validation

What this Trial Is About

This research aims to study the distribution of a radioactive imaging agent called 99mTc-PSMA-I&S in men with prostate cancer who are undergoing pelvic lymph node dissection. The study focuses on detecting prostate cancer spread by using a special imaging method that targets prostate-specific membrane antigen PSMA in both normal and cancerous tissues. This exploratory study is conducted under a regulatory research program and includes histopathology validation when possible. Participants receive intravenous doses of 99mTc-PSMA-I&S. The first five patients get an initial dose followed by five SPECTCT scans at multiple time points between 3 and 46 hours after injection. These five patients then receive a second dose before standard pelvic lymph node surgery. All other patients receive one dose before their scheduled surgery. The study uses advanced imaging techniques to track the agents accumulation in tissues and aims to find the best timing for surgery based on tumor-to-background ratios. During the study, participants undergo imaging scans and surgery as part of their standard care. Researchers collect data on the radioactive agents presence in tissues using imaging and gamma measurements, alongside examining tissue samples for PSMA expression. The main measurement is the uptake values of the agent in tissues over time. Safety and follow-up are aligned with normal surgical care. The study duration extends up to June 2028, with detailed imaging and surgery scheduling during the treatment period.

99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer