Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Diagnosis)
• Intervention / Treatment: Device: Prostate biopsy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rana Harb; Phone Number: 410-502-5500; Email: rharb1@jhmi.edu
• Study Contact Backup: Name: Sara A Naizghi; Phone Number: 720-965-9494 4105501980; Email: snaizgh1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Rana Harb; Phone Number: 410-502-5500; Email: rharb1@jhmi.edu
      • Contact: Sara A Naizghi; Phone Number: 720-965-9494; Email: snaizgh1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transrectal biopsy (TR); Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path	Device: Prostate biopsy; Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot
Experimental: Transperineal biopsy (TP); Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path.	Device: Prostate biopsy; Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device feasibility as assessed by patient discomfort score	Scale 1-10, 10 highest discomfort	Immediately after the procedure
Device feasibility as assessed by maximal procedural pain	Scale 1-10, 10 highest pain	Immediately after the procedure
Device feasibility as assessed by the rate of complications	Rate of complications	Throughout the study, each case recorded within 1 month of the procedure
Device feasibility as assessed by serious adverse events	Serious Adverse events throughout the study	Up to 1 month post procedure
Device feasibility as assessed by the rate of successful completion of cases	Rate of cases completed successfully throughout the study	Immediately post procedure
Device feasibility as assessed by the procedure time	Times of the procedures measured in minutes throughout the study	Immediately post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate cancer detection rates at targeted biopsy (TB)	Clinically significant PCa detection rates at TB throughout the study	Up to 1 month post procedure
Prostate cancer detection rates at systematic biopsy (SB)	Clinically significant PCa detection rates at SB throughout the study	Up to one month post procedure
Needle targeting errors	Measured in ultrasound throughout the study	Immediately post procedure
Prostate deformations (mm)	Maximum deformation of the gland between the start and end of the procedure measured in [mm] throughout the study	Immediately post procedure
Prostate displacement (mm)	Displacement of the gland between the start and end of the procedure measured in [mm] throughout the study	Immediately post procedure

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Misop Han, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Systematic biopsy; Robot biopsy; Fusion biopsy; MRI targeted biopsy; Personalized biopsy; Precision biopsy; Biopsy optimization
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease
• Other Study ID Numbers: IRB00229568; R01CA303859 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes