Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07271017
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Cancer (Diagnosis)

Eligibility Criteria

Sex
MALE
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Prostate biopsy — DEVICE
    Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot

Study Details

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.

Key Dates

Start date
Sep 23, 2025
Status verified
Nov 2025
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Transrectal biopsy (TR)
    Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path
  • Experimental: Transperineal biopsy (TP)
    Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path.

Primary Outcome Measure

Device feasibility as assessed by patient discomfort score [ Time Frame: Immediately after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Rana Harb
[email protected]
410-502-5500
Sara A Naizghi
[email protected]
720-965-9494

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MD

Related Studies