Robot-assisted prostate biopsy using a new ultrasound probe
Official title: Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
Run by Johns Hopkins University · NCT07271017 · Data updated 2026-11-12
This trial will try a robot-guided ultrasound probe to take MRI-fused prostate biopsies in men 40–75 with elevated PSA, abnormal rectal exam, or prior atypical biopsy findings.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 75 Years |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | September 23, 2025 |
| Main results expected | May 31, 2030 |
| Study ends | May 31, 2030 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07271017 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 40–75 with elevated PSA (>4.0 ng/mL), abnormal DRE, or atypical small acinar proliferation on prior biopsy who have mpMRI or bpMRI available are ideal candidates.
✕Probably not a fit
Patients without available mpMRI/bpMRI, those on active anticoagulation, with prior rectal surgery or anal stenosis, who cannot tolerate periprostatic anesthesia, or who already had a ProBot biopsy are not eligible and likely will not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial tests the ProBot, a novel robot and ultrasound probe designed specifically for prostate biopsy, at Johns Hopkins. The device uses two degrees of freedom intended to perform 3D ultrasound scanning and targeted biopsy motions with minimal prostate deformation to improve MRI–ultrasound fusion accuracy. Men with high-risk features (PSA >4.0 ng/mL, abnormal DRE, or ASAP on prior biopsy) and available mpMRI/bpMRI will undergo robot-assisted MRI-fusion and systematic biopsy. The primary goals are to show the device is safe and feasible for clinical use.
Why it matters
Potential benefit: If successful, the ProBot could improve the accuracy of MRI-targeted prostate biopsies and reduce sampling error and the need for repeat procedures.
How similar studies have gone: MRI–ultrasound fusion biopsies have previously improved detection of clinically significant prostate cancer, but the ProBot device and its specific robot-probe kinematics represent a novel approach with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion 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: 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).
Where it's running
-
Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Misop Han, MD — Johns Hopkins University
- Study coordinator: Rana Harb
- Email: rharb1@jhmi.edu
- Phone: 410-502-5500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.