Diagnostic Study Comparing 68Ga-PSMA-11 PET Imaging and mpMRI in Newly Diagnosed, Untreated Prostate Cancer in Men Aged 18 to 80

What this Trial Is About

Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA-11 PET imaging compared to multi-parametric magnetic resonance imaging mpMRI in men with newly diagnosed, untreated prostate cancer. This study aims to further assess how well 68Ga-PSMA-11 PET using PETCT or PETMRI detects prostate tumors in this patient group. The trial is supported by the First Affiliated Hospital of Fujian Medical University and builds upon prior clinical trials validating 68Ga-PSMA-11 PET applications. Participants receive an intravenous injection of 68Ga-PSMA-11 at a dose of 111-148 MBq 3-4 mCi, followed by PETCT or PETMRI scans using standard imaging methods. The study directly compares the detection rates and diagnostic performance of 68Ga-PSMA-11 PET imaging with mpMRI. Radical prostatectomy surgery is scheduled within 28 days after imaging to confirm tumor presence through histopathology. During the study, researchers measure the sensitivity and specificity of 68Ga-PSMA-11 PET in identifying intraprostatic tumors relative to surgical pathology results. Additional assessments compare tumor detection rates between the PET imaging and mpMRI. Participants undergo a whole-body PET scan within 1-2 hours after tracer injection. The trial lasts from screening through imaging and surgery, with data collected to evaluate the diagnostic accuracy of these imaging methods in prostate cancer.

68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI