Robot-Assisted MRI-Guided Prostate Biopsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Robot-Assisted MRI-Guided Prostate Biopsy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Robot-assisted prostate biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted prostate biopsy<br> | Device: Robot-assisted prostate biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Three months | 
| Logged unsuccessful attempts to target prostate |  | 1 year | 
| Time for device setup, image registration, MRI time, biopsy sampling |  | 1 year | 
| Score for operation of the device | Score assigned by the engineers on a 1 to 5 scale | 1 year | 
| Score for image deterioration | Score assigned by radiologist on image quality on a 1 to 5 scale | 1 year | 
| Quality of the obtained biopsy specimen | Score assigned by the pathologist on a 1-5 scale. | 1 year | 
| Overall grade of the device and procedure | Grade give by urologist, radiologist and anesthesiologist on a 1-5 scale. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance from the collected to planned biopsy core center measured on DICOM |  | One year | 
| Number of needle trajectory corrections needed for alignment of each biopsy core |  | 1 year | 
| Number of diagnosed prostate cancers |  | 1 year | 
| Number of positive/total cores for each patient |  | 1 year | 
| Correlation of pathology findings with cancer specific region (CSR)s on MRI |  | 1 year |