Robot-Assisted MRI-Guided Prostate Biopsy

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.

Sex

Male

Minimum age

35 Years

Maximum age

75 Years

Inclusion Criteria:

* men between the ages of 35 and 75,
* have a negative 12 core prostate biopsy, and
* must have one of the following "high risk" features:

  * PSA \>= 5.0 ng/ml and Prostate Volume \<= 50cc,
  * PSA density \>= 0.2ng/ml/cc,
  * Percent Free PSA \<=10%,
  * PSA velocity \> 0.5 ng/ml/year,
  * High Grade Prostate Intraepithelial Neoplasia on previous biopsy, or Atypia on previous biopsy.

Exclusion Criteria:

* bleeding problems,
* metal implants precluding MRI scanning,
* previous rectal surgery, anal stenosis that precludes endorectal coil insertion,
* patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk, and
* patients who are unwilling or unable to sign informed consent.

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