Recruiting
Phase 1

ProBot

Sponsor:

Johns Hopkins University

Code:

NCT07271017

Conditions

Prostate Cancer (Diagnosis)

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Prostate biopsy

Study Details

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 ID

NCT07271017

Start date

Sep 23, 2025

Status verified date

Nov, 2025

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

Prostate biopsy

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

Primary outcome measure

  • Device feasibility as assessed by patient discomfort score [ Time Frame: Immediately after the procedure ]
  • Device feasibility as assessed by maximal procedural pain [ Time Frame: Immediately after the procedure ]
  • Device feasibility as assessed by the rate of complications [ Time Frame: Throughout the study, each case recorded within 1 month of the procedure ]
  • Device feasibility as assessed by serious adverse events [ Time Frame: Up to 1 month post procedure ]
  • Device feasibility as assessed by the rate of successful completion of cases [ Time Frame: Immediately post procedure ]
  • Device feasibility as assessed by the procedure time [ Time Frame: Immediately post procedure ]

Central Contacts and Locations

Central contacts

Rana Harb

410-502-5500rharb1@jhmi.edu

Sara A Naizghi

4105501980snaizgh1@jh.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rana Harb

410-502-5500rharb1@jhmi.edu

Sara A Naizghi

720-965-9494snaizgh1@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 8, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-08.