Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT02871726
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TRUS-Robot — DEVICE
    A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
  • TRUS biopsy — OTHER
    Uronav for prostate biopsy.

Study Details

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 Dates

Start date
Nov 24, 2021
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
483 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

Cancer Detection Rate of Clinically Significant Prostate Cancer [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Misop Han, M.D.
410-614-9442

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Johns Hopkins Hospital· Baltimore, MD

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