Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

NCT07271017 | Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: IRB00229568R01CA303859
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Robot biopsy; Fusion biopsy; MRI targeted biopsy; Systematic biopsy; Personalized biopsy; Precision biopsy; Biopsy optimization

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Prostate cancer detection rates at targeted biopsy (TB)

  Up to 1 month post procedure

• Prostate cancer detection rates at systematic biopsy (SB)

  Up to one month post procedure

• Needle targeting errors

  Immediately post procedure

• Prostate deformations (mm)

  Immediately post procedure

• Prostate displacement (mm)

  Immediately post procedure

Study Arms (2)

Transrectal biopsy (TR)

EXPERIMENTAL

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

Device: Prostate biopsy

Transperineal biopsy (TP)

EXPERIMENTAL

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

Device: Prostate biopsy

Interventions

Prostate biopsy DEVICE

Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot

Transperineal biopsy (TP); Transrectal biopsy (TR)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Misop Han, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Harb

CONTACT

410-502-5500; rharb1@jhmi.edu

Sara A Naizghi

CONTACT

4105501980; snaizgh1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are enrolled consecutively in the TR or TP biopsy groups by the urologists and accounting for patient's preference

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)