NCT07600216Not yet recruiting
A Multicenter, Randomized Controlled Superiority Trial Comparing Robotic-Assisted Versus Expert Cognitive Fusion Prostate Biopsy in Obese Men
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 14 May 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Obesity
- NCT number
- NCT07600216
What you commit to
- Study type: Interventional
- Planned participants: 570
- From 1 Jan 2027 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for prostate cancer.
Other illness
- History of major anorectal surgery preventing safe transperineal probe insertion.
Other
- Contraindications to MRI.
- Negative screening MRI (PI-RADS 1-2).
Who the study is looking for
- 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.
- Fitness for transperineal biopsy under local anaesthesia or conscious sedation.
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.