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Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Sponsor: Johns Hopkins University
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).
Key Details
Gender
MALE
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
483
Start Date
2021-11-24
Completion Date
2026-08
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
TRUS-Robot
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
TRUS biopsy
Uronav for prostate biopsy.
Locations (1)
Johns Hopkins Hospital
Baltimore, Maryland, United States