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Robot aims to improve prostate cancer diagnosis

NCT ID NCT07271017

Diagnosis Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a new robot and ultrasound probe, called ProBot, designed to make prostate biopsies more precise and comfortable. The study will enroll 60 men with suspected prostate cancer to see if the device is safe and works as intended. If successful, it could lead to better detection of aggressive cancers while reducing unnecessary procedures.

What this could mean

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

Active substance
ProBot robot and novel ultrasound probe
What this could lead to
If successful, this could make prostate biopsies more accurate and less painful, improving cancer detection.
What could go wrong
This is a small, early-phase safety and feasibility study. The device may not work better than current methods, and unexpected complications could arise.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Sep 2025

Expected to finish

May 2030

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 to 75 years

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.

Included in the study will be: * Men between the ages of 40 and 75 * Men must have one of the following "high risk" features: 1. PSA \> 4.0 ng/ml and/or abnormal digital rectal examination (DRE) 2. ASAP (atypical small acinar proliferation) on previous biopsy * Men with mpMRI or bpMRI exams, including both PI-RADS ≤2 and PI-RADS ≥3. Excluded from the study will be patients without available mpMRI exams and patients: * Females and children because of the prostate cancer targeted disease. * Patients who are not recommended or in whom TR or TP prostate biopsy is considered high-risk: 1. Patients with previous rectal surgery. 2. Patients with anal stenosis or coagulopathy. 3. Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin). 4. Patients who cannot tolerate periprostatic Lidocaine block anesthesia or in whom anesthesia is considered high-risk. * Patients who already had a prostate biopsy taken with the ProBot investigational device. * Vulnerable populations, such as prisoners, institutionalized individuals. * Patients who are unwilling or unable to sign informed consent (no assent required).

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

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

Prostate cancer (diagnosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

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