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NCT Number: NCT07271017

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.

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Key information

Conditions

Prostate Cancer (Diagnosis) Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Included in the study will be:

  • Men between the ages of 40 and 75
  • Men must have one of the following "high risk" features:
  • PSA > 4.0 ng/ml and/or abnormal digital rectal examination (DRE)
  • 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:
  • Patients with previous rectal surgery.
  • Patients with anal stenosis or coagulopathy.
  • Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin).
  • 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).

Treatment and study plan

prostate biopsy

Device

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

Primary outcomes

  1. Device feasibility as assessed by patient discomfort score

    Time frame: Immediately after the procedure

    Scale 1-10, 10 highest discomfort

  2. Device feasibility as assessed by maximal procedural pain

    Time frame: Immediately after the procedure

    Scale 1-10, 10 highest pain

  3. Device feasibility as assessed by the rate of complications

    Time frame: Throughout the study, each case recorded within 1 month of the procedure

    Rate of complications

  4. Device feasibility as assessed by serious adverse events

    Time frame: Up to 1 month post procedure

    Serious Adverse events throughout the study

  5. Device feasibility as assessed by the rate of successful completion of cases

    Time frame: Immediately post procedure

    Rate of cases completed successfully throughout the study

  6. Device feasibility as assessed by the procedure time

    Time frame: Immediately post procedure

    Times of the procedures measured in minutes throughout the study

Secondary outcomes

  1. Prostate cancer detection rates at targeted biopsy (TB)

    Time frame: Up to 1 month post procedure

    Clinically significant PCa detection rates at TB throughout the study

  2. Prostate cancer detection rates at systematic biopsy (SB)

    Time frame: Up to one month post procedure

    Clinically significant PCa detection rates at SB throughout the study

  3. Needle targeting errors

    Time frame: Immediately post procedure

    Measured in ultrasound throughout the study

  4. Prostate deformations (mm)

    Time frame: Immediately post procedure

    Maximum deformation of the gland between the start and end of the procedure measured in [mm] throughout the study

  5. Prostate displacement (mm)

    Time frame: Immediately post procedure

    Displacement of the gland between the start and end of the procedure measured in [mm] throughout the study

Study contacts

Contact information is provided by the study sponsor or research team.

Rana Harb

CONTACT

[email protected]

410-502-5500

Sara A Naizghi

CONTACT

[email protected]

4105501980 ext. 720-965-9494

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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