NCT07271017RecruitingPhase 1
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 23 Sept 2025
- Primary completion date
- 31 May 2030
- Lead sponsor
- Johns Hopkins University
- Diseases
- Prostate cancer
- NCT number
- NCT07271017
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 23 Sept 2025 to the primary completion date, 31 May 2030
- 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.
Criteria the registry did not label
- 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).
Age in the registry: 40 years to 75 years · 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 |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.