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Robot arm vs expert hand: can tech beat tremor in prostate biopsies for obese men?

NCT ID NCT07600216

Diagnosis Sponsor: Shanghai East Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares robotic-assisted prostate biopsy to expert manual biopsy in 570 men with high BMI and suspicious MRI findings. The robot locks the needle in place to avoid hand tremors and improve accuracy. The main goal is to see if the robot detects more clinically significant prostate cancers safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robotic-assisted fusion biopsy procedure
What this could lead to
If successful, this could show that robotic assistance helps detect more aggressive prostate cancers in men with obesity, improving diagnosis in a group where manual biopsy is challenging.
What could go wrong
This is a relatively early-stage trial (not yet recruiting) and the benefit may be small or not clinically meaningful. The robotic system may also have technical issues or higher costs that limit widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 570 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate biopsy

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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