Robot-Assisted MRI-Guided Prostate Biopsy

January 10, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted prostate biopsy
Device: Robot-assisted prostate biopsy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • Principal Investigator: Mohamad E Allaf, MD, Johns Hopkins University
  • Study Director: Mark W Ball, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1163
  • 1RC1EB010936-01 (U.S. NIH Grant/Contract)
  • NA_00025078 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Robot-assisted prostate biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe