Ultrasound Based Transperineal Robotic Biopsy of the the Prostate (BxB)

April 12, 2010 updated by: Singapore General Hospital

Study of Prostate Cancer Detection With in House Developed Robot

The objective of the study is to examine the effectiveness and accuracy of the BioXbot in prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the procedures is based on:

  • Uptake rate
  • Peripheral zone reachability
  • Needling accuracy
  • Procedure execution time
  • Post operative discomfort or trauma experienced by patient
  • Quality and type of tissue sample extracted
  • Adverse and unanticipated side-effects on patient after the procedure and recording any unexpected reactions

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prostate gland is a walnut-sized organ found only in men that encircles the urethra (urine passage) below the urinary bladder. It secretes fluid that is an important component of semen. Prostate cancer is a disease of the prostate gland where malignant tumours cells invade normal prostate tissue and spread to other organs. It is second leading cause of cancer death in men and it is mainly found in men above the age of 50 years.

Prostate biopsy is considered to be the most definitive diagnostic tool for prostate cancer. It is a surgical procedure in which a small sample of tissue is removed from the prostate gland and examined by a pathologist. The procedure normally takes about 15 minutes and is usually performed by the urologist in conjunction with transrectal ultrasound (TRUS). No anesthetic is required. With the help of TRUS, a doctor guides a biopsy gun -- a hand-held device with a spring-loaded, slender needle -- through the wall of the rectum into the area of the prostate gland that appears abnormal. Since the rectal wall is thin, it is possible to place the needle more accurately and with less injury to other tissues. When activated, the needle can remove a slender cylinder of tissue, called a core.

Transrectal ultrasound-guided prostate biopsy has become the standard for obtaining tissue for the histological diagnosis of prostate cancer. On the other hand, transperineal approach is not commonly used worldwide and little data is available on transperineal prostate biopsy.

However, there are some problems with existing system and these include:

  • Random Biopsy Sites: Biopsy cores represent only about 0.6% of the prostate in terms of volume. Therefore, without having accurate knowledge of cancer sites, it is unlikely that a random biopsy protocol will yield consistently high cancer detection rates.
  • Inaccurate Needling: The biopsy needle may not reach the desired position accurately and quickly under manual control.
  • Limited 2D Guidance: The TRUS used for biopsy guidance is 2D ultrasound images. As the biopsy sites are distributed in 3D, it is difficult for the surgeon to imagine the overall picture of the biopsy sites and identify the biopsy site accurately and intuitively.
  • Risk Factors: The two primary risks of needle biopsy are severe bleeding and infection of the prostate gland or urinary tract.
  • Transrectal Shortfalls: As most of the cancer occurs at the apex area of the prostate, transperineal biopsy is considered having higher chance to get cancer tissue, comparing with the conventional transrectal biopsy. Furthermore, transperineal biopsy is considered "cleaner", as its puncture point is on skin, rather than on rectum.

To assist the surgeon in transperineal biopsy, a device name BioXbot has been designed. BioXbot aims to address the shortfalls of the transrectal method of biopsy and limitations of existing robotic biopsy in order to improve the cancer uptake rate. An ideal design should need no more than 2 operators to complete the procedure comfortable within comparable time with the conventional approach. A motorized needle positioning mechanism may also improve the accuracy in the needling and allow the needle reach any point within the prostate in all scenarios.

BioXbot is a computer based motion control system with software driven gantry mechanism to assist in the positioning of the biopsy gun. It drives a 2D ultrasound probe to obtain a series of 2D images of the prostate which will then be modeled into a 3D view. This 3D visualization gives the surgeon a better idea of the prostate and allows him to plan the biopsy sites more intuitively. The mechanical components precisely align it to allow the clinician to accurately reach the position inside the prostate he wanted to and obtain tissue from there. To improve the usability and the positioning accuracy, as well as reducing the operation time, the positioning of the needle is fully motorized.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christoper Cheng
        • Sub-Investigator:
          • Henry Ho
        • Sub-Investigator:
          • John Yuen

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • At least one normal previous prostate biopsy and at least 2 weeks since prior prostate biopsy
  • Increasing prostate-specific antigen (PSA) level
  • The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria

Exclusion Criteria:

  • Patient with operative risk ASA ( American Society of Anaesthesia) = or > 4
  • A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
  • Patients with psychiatric diseases or insufficient cerebral function

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transperineal Biopsy
Biopsy of the prostate using transperineal approach
Procedure: Robotic Transperineal Biopsy
Saturation biopsy for previous negative patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Detection
Time Frame: 2 years
to detect any undetected cancer in Patietns undergoing saturation biopsy
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy and Repeatability
Time Frame: 6 months
To be accurate in biopsy position (+/- 2mm) and be able to go back to the same position if patient undergoes treatment.
6 months

Collaborators and Investigators

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

Sponsor

Singapore General Hospital

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

May 1, 2006

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

April 11, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

May 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • BioXbot

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.

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