A Multicenter, Randomized Controlled Superiority Trial Comparing Robotic-Assisted Versus Expert Cognitive Fusion Prostate Biopsy in Obese Men

The trial aims to find out if using a robotic system to help perform prostate biopsies is better than having a highly experienced doctor perform the biopsy by hand in men with a high Body Mass Index (BMI). While MRI-guided prostate biopsies are highly effective, carrying them out in men with obesity can be physically challenging for doctors. Extra pelvic tissue increases the depth the biopsy needle must travel and makes it difficult to manually hold the ultrasound probe perfectly steady. This physical difficulty might cause doctors to miss some aggressive prostate cancers. This study tests whether a robotic arm-which completely locks the biopsy needle on target and eliminates human hand tremors-can improve cancer detection. The study will enroll up to 570 men with high BMI who have suspicious areas on their prostate MRI. Participants will be randomly assigned to receive either a robotic-assisted biopsy or a standard manual biopsy performed by an expert urologist. To ensure the results are completely unbiased, participants will not know which method is being used on them. They will be placed behind a surgical drape and wear noise-canceling headphones playing music during the procedure to block out the sounds of the robotic motors. The main goal is to see if the robotic method safely and significantly increases the detection rate of clinically significant prostate cancer in this specific group of patients.

NCT Number	NCT07600216
Lead Sponsor	Shanghai East Hospital
Conditions	Prostate Biopsy
Enrollment	570 participants
Start Date	2026-05-30
Primary Completion	2028-05-30 (estimated)
Study Completion	2028-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-24