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Taking people in United StatesPhase 1

Testing a New Robot for Prostate Biopsy in Men With Suspected Prostate Cancer

Tests a new ultrasound-guided robot for prostate biopsy in men with suspected prostate cancer.

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the site
Trial code
Registry title
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
Status
Recruiting
Phase
Phase 1
People taking part
60 people, planned
Started
23 Sept 2025
Expected to end
31 May 2030
Type of study
Interventional, 2 groups
Treatments tested
  • Prostate biopsy
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men aged 40 to 75 who have a higher chance of prostate cancer and need a prostate biopsy. It tests a new robot and ultrasound probe for taking the biopsy.

Age
40 to 75 years
Sex
Men only
Disease stage
Men with a higher chance of prostate cancer: PSA above 4.0 ng/ml and/or an abnormal digital rectal examination, or ASAP (atypical small acinar proliferation) on a previous biopsy. They must have an MRI exam (mpMRI or bpMRI), with PI-RADS 2 or lower, or 3 or higher.
Earlier treatment
Men who already had a prostate biopsy with the ProBot device cannot join.
Biomarker or test result
PSA above 4.0 ng/ml and/or an abnormal digital rectal examination, or ASAP on a previous biopsy.

Main reasons for not taking part

  • No available mpMRI exam
  • Previous rectal surgery
  • Anal stenosis or coagulopathy
  • Taking blood thinners such as Coumadin, Lovenox or Heparin
  • Cannot tolerate periprostatic Lidocaine block anesthesia, or anesthesia is high-risk

The registry criteria, word for word

Show all 9 criteriaShow less

Other criteria

  • Included in the study will be:
  • Men between the ages of 40 and 75
  • Men must have one of the following "high risk" features:; PSA > 4.0 ng/ml and/or abnormal digital rectal examination (DRE); 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:; Patients with previous rectal surgery; Patients with anal stenosis or coagulopathy; Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin); 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 75 years old?

Where in United States

  • Johns Hopkins HospitalBaltimore, United StatesContact: Rana HarbTaking people

About the trial

What the trial wants to find out

Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Efforts to address the rise in PCa diagnosis without overdetection and overtreatment include targeted biopsy techniques for clinically significant PCa using magnetic resonance imaging (MRI), and precision targeted biopsy guided by ultrasound and fused to the MRI.

Read full original descriptionShow less

The study aims to improve prostate biopsy with a novel ultrasound probe and robot developed at Johns Hopkins, the ProBot device. The trial is a Phase 1 clinical trial to evaluate the safety and feasibility of the new device.

ProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for the prostate. It operates with only two degrees of freedom configured such that the motions for 3D image scanning and biopsy may not deform the prostate gland, thus improving the accuracy of MRI-ultrasound fusion and needle targeting at biopsy.

ProBot is a small and lightweight robot (1.3Kg including the ultrasound probe). It allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting supervised by the urologist.

In addition to MRI-targeted biopsy (TB), at systematic biopsy (SB), instead of using the common template plan that is the same for all patients, the innovative software optimizes the plan for each patient to obtain a diagnosis that is representative of the whole gland histology. The ProBot robot is also uniquely capable of transrectal (TR) and transperineal (TP) biopsy.

The aims of the study are to determine the safety and feasibility of the new device at TR and TP biopsies.

The 2 groups in the trial

  • Transrectal biopsy (TR)Treatment being tested

    Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path

    Treatment: Prostate biopsy

  • Transperineal biopsy (TP)Treatment being tested

    Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path.

    Treatment: Prostate biopsy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
Plain-language title
Testing a New Robot for Prostate Biopsy in Men With Suspected Prostate CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07271017, who can take part
Record updated
6 November 2026