Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Clinicaltrials.gov ID: NCT02871726
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 45 - 75 Years
b-bullseye-arrow Enrollments 483

Conditions

Prostate Cancer

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).

Detailed Description

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Misop Han, M.D.
  • 410-614-9442

Principal Investigator

  • Misop Han, M.D., M.S.

Eligibility Criteria

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

Study Plan

TRUS-Robot and TRUS

EXPERIMENTAL

TRUS and TRUS-Robot will be used during prostate biopsy

  • DEVICE:

    TRUS-Robot

    Description:

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

    TRUS biopsy

    Description:

    Uronav for prostate biopsy.

Routine TRUS/Fusion biopsy

ACTIVE_COMPARATOR

Just Uronav will be used during prostate biopsy

  • OTHER:

    TRUS biopsy

    Description:

    Uronav for prostate biopsy.

Outcome Measures

Primary Outcome Measures

Cancer Detection Rate of Clinically Significant Prostate Cancer

Time Frame: 5 years

Investigational device serious adverse events

Time Frame: 5 years

Cancer Detection Rate of Clinically Insignificant Prostate Cancer

Time Frame: 5 years

Secondary Outcome Measures

Needle targeting accuracy

Time Frame: 5 years

Procedure time

Time Frame: Up to 30 minutes

Sensitivity of detecting clinically significant prostate cancer at biopsy

Time Frame: 5 years

Specificity of detecting clinically significant prostate cancer at biopsy

Time Frame: 5 years

Predictive rates of detecting clinically significant prostate cancer at biopsy

Time Frame: 5 years

Timeline

  • Last Updated
    February 13, 2024
  • Start Date
    August 18, 2016
  • Today
    January 22, 2025
  • Completion Date ( Estimated )
    August 1, 2026

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