Evaluating Needle Size for MRI-Guided Transperineal Prostate Biopsy to Improve Cancer Detection Without Increasing Side Effects

What this Trial Is About

Researchers are evaluating if using a larger needle size 16 gauge during transperineal MRI-targeted prostate biopsy improves the detection of prostate cancer compared to a smaller needle size 18 gauge, without increasing side effects or complications. This study focuses on patients suspected of having prostate cancer based on elevated prostate-specific antigen levels or suspicious digital rectal exams, with at least one suspicious lesion on MRI. Participants will undergo a prostate biopsy using either a 16 gauge or 18 gauge needle guided by MRI fusion technology. This randomized study compares the diagnostic accuracy and side effect profiles of these two needle sizes. The main treatments involve device-based prostate biopsy performed through the skin between the scrotum and anus transperineal. During the study, researchers will assess the number of biopsies detecting prostate cancer, including clinically significant cases, using histology reports. They will also monitor pain levels, hospitalizations, and complications up to 60 days after biopsy. Participants will be followed for safety and outcomes, with pain assessed via a visual scale and clinical data collected post-procedure.

Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?