Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• Scheduled for an initial diagnostic biopsy

• Elevated serum PSA (prostate specific antigen\> 4 ng/ml) and/or abnormal digital rectal exam

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Misop Han, M.D., M.S.
mhan1@jhmi.edu
410-614-9442
Backup
Dan Stoianovici, PhD
dss@jhu.edu
410-550-1980
Time Frame
Start Date: 2021-11-24
Estimated Completion Date: 2026-08
Participants
Target number of participants: 483
Treatments
Experimental: TRUS-Robot and TRUS
TRUS and TRUS-Robot will be used during prostate biopsy
Active_comparator: Routine TRUS/Fusion biopsy
Just Uronav will be used during prostate biopsy
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov