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

Summary

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.

Conditions

• Prostate Biopsy

Interventions

PROCEDURE

Robotic-Assisted Fusion Biopsy

Participants in this arm will undergo a transperineal prostate biopsy utilizing a dedicated robotic fusion platform. The system features a mechanical arm or rigid fixator that completely locks the ultrasound probe and needle guide into a pre-planned coordinate trajectory. This mechanical stabilization uncouples the needle guide from manual human force, eliminating operator hand tremor and the "fulcrum effect" caused by deep pelvic adiposity. The urologist will obtain 3 to 4 targeted cores per MRI-visible lesion (PI-RADS ≥ 3) using the robotic interface, followed by a standard systematic biopsy. To prevent performance bias and placebo effects, participants will be blinded to the intervention using a high surgical drape and noise-canceling headphones.

PROCEDURE

Expert Cognitive Fusion Biopsy

Participants in this arm will undergo a standard manual transperineal prostate biopsy. To represent "peak human performance," the procedure will be performed exclusively by an expert urologist credentialed with a documented history of \>500 total prostate biopsies, including \>200 cognitive fusion targeted cases. The operator will mentally register the MRI lesion onto the real-time ultrasound image using anatomical landmarks, without the aid of any software overlay or robotic mechanical stabilization. The urologist will manually obtain 3 to 4 targeted cores per MRI-visible lesion (PI-RADS ≥ 3), followed by a standard systematic biopsy. To maintain the single-blind study design, participants will be shielded by a surgical drape and wear noise-canceling headphones.

Sponsors & Collaborators

• Shanghai East Hospital

  lead OTHER

Principal Investigators

• haifeng wang · Shanghai East Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-30

Primary Completion

2028-05-30

Completion

2028-05-30