Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

NCT ID: NCT07271017

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2030-05-31

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Transrectal biopsy (TR)

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

Group Type: EXPERIMENTAL

Prostate biopsy

Intervention Type: DEVICE

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

Transperineal biopsy (TP)

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

Group Type: EXPERIMENTAL

Prostate biopsy

Intervention Type: DEVICE

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

Interventions

Prostate biopsy

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

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

• 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Misop Han, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rana Harb

Role: CONTACT

rharb1@jhmi.edu

410-502-5500

Sara A Naizghi

Role: CONTACT

snaizgh1@jh.edu

4105501980 ext. 720-965-9494

Facility Contacts

Rana Harb

Role: primary

rharb1@jhmi.edu

410-502-5500

Sara A Naizghi

Role: backup

snaizgh1@jh.edu

720-965-9494

Other Identifiers

R01CA303859

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00229568

Identifier Type: -

Identifier Source: org_study_id