Study of 18FPSMA-1007 PETCT Imaging to Diagnose Newly-Diagnosed High-Risk Prostate Cancer in Adult Men

What this Trial Is About

Researchers are evaluating the diagnostic performance of the radiopharmaceutical 18FPSMA-1007 PETCT imaging in patients newly diagnosed with high-risk or very-high-risk prostate cancer. This phase 3 study focuses on men with biopsy-proven, localized prostate adenocarcinoma who are candidates for curative prostatectomy and extended pelvic lymph node dissection. The goal is to compare the accuracy of 18FPSMA-1007 PETCT scans with histology results to detect pelvic nodal disease. Participants will receive a single intravenous dose of 18FPSMA-1007, followed by a PETCT scan to assess prostate cancer spread. Before the PETCT, participants must have had conventional imaging such as CT or MRI and bone scans if needed, within 60 days of the PETCT procedure. The study does not use blinding or placebo controls. Throughout the study, researchers will collect imaging data and compare PETCT findings to surgical histology obtained 6 to 8 weeks after surgery. Safety and diagnostic accuracy will be monitored. The study is expected to continue through September 2027. Participants will be closely evaluated during the imaging and surgery process, with follow-up to assess the detection of cancer involvement in pelvic lymph nodes.

Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer