Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Johns Hopkins University
483 participants
Nov 24, 2021
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria2
- Scheduled for an initial diagnostic biopsy
- Elevated serum PSA (prostate specific antigen\> 4 ng/ml) and/or abnormal digital rectal exam
Exclusion Criteria5
- 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
Interventions
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
Uronav for prostate biopsy.
Locations(1)
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NCT02871726