Home › Prostate Cancer › NCT02871726
Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Who can join
Ages 45 to 75 · Men
Full 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
About the study
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).
What is being tested
- TRUS-Robot (device)
- TRUS biopsy (other)
Sponsor: Johns Hopkins University · Participants: 483 · Started: Nov 24, 2021
Contact the study team
- Misop Han, M.D., M.S. · Phone: 410-614-9442
- Dan Stoianovici, PhD · Phone: 410-550-1980
Official record on ClinicalTrials.gov — NCT02871726
Locations in the U.S.
| Maryland | Johns Hopkins Hospital, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.