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NCT Number: NCT02871726

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Misop Han, M.D.

CONTACT

410-614-9442

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TRUS-Robot

Device

A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.

TRUS biopsy

Other

Uronav for prostate biopsy.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. 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.

  2. Procedure time

    Time frame: Up to 30 minutes

    The time of the actual biopsy procedure measured in minutes.

  3. 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.

  4. 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. 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.

Study contacts

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

Dan Stoianovici, PhD

CONTACT

[email protected]

410-550-1980

Misop Han, M.D., M.S.

CONTACT

[email protected]

410-614-9442

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2016
Registry last updated
Feb 23, 2026

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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