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Transrectal Ultrasound Robot-Assisted Prostate Biopsy

RECRUITINGN/ASponsored by Johns Hopkins University
Actively Recruiting
PhaseN/A
SponsorJohns Hopkins University
Started2021-11-24
Est. completion2026-08
Eligibility
Age45 Years – 75 Years
SexMALE
Healthy vol.Accepted
Locations1 site

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

Age: 45 Years – 75 YearsSex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

Locations1 site

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Misop Han, M.D.410-614-9442

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