Transrectal Ultrasound Robot-Assisted Prostate Biopsy

August 25, 2026 updated by: Johns Hopkins University
Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Study Type

Interventional

Enrollment (Estimated)

483

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Misop Han, M.D., M.S.
  • Phone Number: 410-614-9442
  • Email: mhan1@jhmi.edu

Study Contact Backup

  • Name: Dan Stoianovici, PhD
  • Phone Number: 410-550-1980
  • Email: dss@jhu.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Misop Han, M.D.
          • Phone Number: 410-614-9442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled for an initial diagnostic biopsy
  • Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria:

  • Clinical diagnosis of prostate cancer
  • Prior prostate biopsy
  • Anal stenosis that prevents TRUS probe insertion
  • Inadequate bowel prep
  • Unwilling or unable to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRUS-Robot and TRUS
TRUS and TRUS-Robot will be used during prostate biopsy
Device: TRUS-Robot
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
Other: TRUS biopsy
Uronav for prostate biopsy.
Active Comparator: Routine TRUS/Fusion biopsy
Just Uronav will be used during prostate biopsy
Other: TRUS biopsy
Uronav for prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Detection Rate of Clinically Significant Prostate Cancer
Time Frame: 5 years
Number of biopsy patients diagnosed with Gleason score >= 7 over the total number of patients on both arms of the study.
5 years
Investigational device serious adverse events
Time Frame: 5 years
Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).
5 years
Cancer Detection Rate of Clinically Insignificant Prostate Cancer
Time Frame: 5 years
Number of biopsy patients diagnosed with Gleason score <= 6 over the total number of patients on both arms of the study.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needle targeting accuracy
Time Frame: 5 years
Needle targeting errors will be measured as the distance between the planned core center and the inserted needle axis. Targeting accuracy will be calculated as the average of the needle targeting errors, as usual.
5 years
Procedure time
Time Frame: Up to 30 minutes
The time of the actual biopsy procedure measured in minutes.
Up to 30 minutes
Sensitivity of detecting clinically significant prostate cancer at biopsy
Time Frame: 5 years
Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate sensitivity.
5 years
Specificity of detecting clinically significant prostate cancer at biopsy
Time Frame: 5 years
Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate specificity.
5 years
Predictive rates of detecting clinically significant prostate cancer at biopsy
Time Frame: 5 years
Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate predictive rates.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Misop Han, M.D., M.S., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimated)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00068488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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