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Study of Prostate Cancer Detection With in House Developed Robot

Phase 1/Phase 2
Open (Enrolling)
Previous Negative Biopsy

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Trial Information

Study of Prostate Cancer Detection With in House Developed Robot

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

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

- 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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Cancer Detection

Outcome Description:

to detect any undetected cancer in Patietns undergoing saturation biopsy

Outcome Time Frame:

2 years

Safety Issue:



Singapore: Health Sciences Authority

Study ID:




Start Date:

May 2006

Completion Date:

June 2011

Related Keywords:

  • Previous Negative Biopsy