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RECRUITING Not applicable ClinicalTrials.gov

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT02871726

Registry updated: 2026-08-26
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Description

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).

Interventions

  • 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.

Eligibility criteria

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

Conditions

Prostate Cancer

Locations

  • Johns Hopkins Hospital — Baltimore, Maryland, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record