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Transrectal Ultrasound Robot-Assisted Prostate Biopsy

NCT02871726 · Johns Hopkins University · Updated 26 Aug 2026

What is being tested
TRUS-Robot; TRUS biopsy
For
Prostate Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 45 years to 75 years. About 483 people. The full rules are on the registry page.
Where
United States
When
Starts or started 24 Nov 2021, ends Aug 2029. Registered 18 Aug 2016.
Results
None posted yet.

In the researchers' words

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).
ClinicalTrials.gov, NCT02871726

Sites

  • Johns Hopkins HospitalBaltimore, Maryland, United States