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.
Age ≥ 40 years.
Serum PSA levels between 4 and 20 ng/ml and/or abnormal digital rectal examination (DRE).
High Body Mass Index (BMI): defined as ≥ 28 kg/m ² for Asian cohorts and ≥ 30 kg/m ² for Non-Asian cohorts.
MRI-Positive: Presence of at least one suspicious lesion (PI-RADS score ≥ 3) on mpMRI.
Prior treatment for prostate cancer.
History of major anorectal surgery preventing safe transperineal probe insertion.
Contraindications to MRI.
Negative screening MRI (PI-RADS 1-2).
Parallel
Robotic-Assisted Fusion Biopsy
Procedure/SurgeryParticipants 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.
Expert Cognitive Fusion Biopsy
Procedure/SurgeryParticipants 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.
Detection Rate of Clinically Significant Prostate Cancer (csPCa) by Targeted Biopsy
The primary efficacy endpoint is the proportion of participants in the intention-to-treat (ITT) population diagnosed with clinically significant prostate cancer (csPCa) specifically from the targeted biopsy cores. csPCa is strictly defined histopathologically as International Society of Urological Pathology (ISUP) Grade Group 2 or higher (Gleason score 3+4=7 or greater).
Detection Rate of Any Prostate Cancer by Targeted Biopsy
The proportion of participants in whom any prostate cancer, defined as ISUP Grade Group 1 or higher (Gleason score 3+3=6 or greater), is detected specifically from the targeted biopsy cores.
Detection Rate of csPCa by Combined Biopsy
The proportion of participants diagnosed with clinically significant prostate cancer (ISUP Grade Group 2 or higher) when combining the pathological results from both the targeted biopsy cores and the standard systematic biopsy cores.
Pathological Upgrade Rate
The proportion of participants in whom the targeted biopsy cores detect a higher ISUP Grade Group of prostate cancer compared to the ISUP Grade Group detected by the background systematic biopsy cores in the same patient.
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