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RECRUITING
NCT02871726
NA

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

DEVICE

TRUS-Robot

A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.

OTHER

TRUS biopsy

Uronav for prostate biopsy.

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States