Robot-Assisted MRI-Guided Prostate Biopsy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance
      (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the
      procedure has high false-negative rates. This represents a daily problem for urologists
      managing the disease, creates uncertainty and emotional stress for patients, and initiates a
      cascade of repeat testing and biopsies which also burden the investigators healthcare system.

      The investigators believe that prostate biopsy can be improved by using a new biopsy
      paradigm. The investigators plan to perform MRI-guided prostate biopsies with
      robot-assistance for orienting a needle-guide through which the biopsy is taken. The
      combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity
      compared to regular TRUS biopsies.

      The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety.
      The needle-guide robot is an investigational device developed in their Urology Robotics
      Laboratory.
    

Detailed description: 
      While prostate cancer is the most common non-dermatologic malignancy among men in the US, it
      is frequently indolent and may not require radical therapy, i.e. radical prostatectomy or
      external beam radiotherapy. There has been increased interest in conservative approaches to
      low risk disease, including both active surveillance and focal therapy. Both of these
      approaches require accurate mapping of the prostate to allow for reproducible access to
      diseased portions of the gland, for biopsy or treatment purposes. Magnetic resonance imaging
      (MRI) has been increasingly utilized for prostate cancer staging and is considered the most
      accurate technique available for imaging prostate cancer. Furthermore there is increasing
      concern about the use of freehand transrectal ultrasound (TRUS) and needle biopsying in terms
      of reproducibility and accuracy in mapping disease. With systematic TRUS-guided biopsy the
      sensitivity of the test is low (33%-44%) and yields high false-negative rates (23%) [1, 2].

      The investigators hypothesize that the integration of a novel robotic device for assisting
      MRI-guided prostate biopsy is feasible, safe, and accurate. This represents the first
      clinical trial of robotic assistance for MRI-guided transperineal prostate biopsy. The device
      consists of a robotic needle-guide instrument developed in the investigators Urology Robotics
      Laboratory. The robot orients a needle-guide on target based on MRI. The physician verifies
      the alignment and manually takes the biopsy, as usual. Pre-clinical tests showed that the
      robot operates precisely and safely in the MRI scanner and does not deteriorate imaging
      quality.
    

Intervention name(s): Robot-assisted prostate biopsy
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility