Safety and Efficacy Clinical Trial of Robot‐Assisted Prostate Biopsy Using a Hand‐Held Robotic System

BACKGROUND: Robotic systems are increasingly utilised to improve clinical outcomes in prostate interventions. METHODS: We enroled 20 patients to verify the clinical feasibility of transrectal ultrasound (TRUS)-guided robot-assisted prostate biopsy (PBx). For each patient, controlled trials of systematic 12-core PBx were initially conducted manually using a biopsy gun, followed by a 3-core cognitive fusion targeted biopsy performed by the hand-held robot. RESULTS: The targeting errors for robot-assisted biopsy and freehand biopsy were 3.71 ± 1.41 mm and 3.94 ± 1.49 mm, respectively. Their cancer core rates were 19.1% and 12.6%, and the average duration of each biopsy was 6.94 min and 1.62 min, respectively. CONCLUSIONS: The robot's sampling success rate was lower than that of freehand with a biopsy gun in the clinical trial. However, robot-assisted PBx has shown improved cancer core rate, slightly enhanced surgical accuracy, and the capability to reach clinically significant tumours' 5 mm error range, all demonstrating its clinical value.