RecruitingNot ApplicableNCT02871726

Transrectal Ultrasound Robot-Assisted Prostate Biopsy


Sponsor

Johns Hopkins University

Enrollment

483 participants

Start Date

Nov 24, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 45 YearsMax Age: 75 Years

Inclusion Criteria2

  • Scheduled for an initial diagnostic biopsy
  • Elevated serum PSA (prostate specific antigen\> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria5

  • 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

Interventions

DEVICETRUS-Robot

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

OTHERTRUS biopsy

Uronav for prostate biopsy.


Locations(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT02871726


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