Previous Negative BiopsyPhase 1/2BxBNCT01102361
Ultrasound Based Transperineal Robotic Biopsy of the the Prostate
A Phase 1/2 study testing Robotic Transperineal Biopsy in people with Previous Negative Biopsy, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Previous Negative Biopsy
- What is being tested?
- Robotic Transperineal Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSingapore
- Study dates
- May 2006to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Henry Ho, Doctor contact
Preeti Mohan, Biomedical Engineer contact
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, Singapore, 169608
Henry Ho, Doctor, ho.henry.s.s@gmail.com
Preeti Mohan, preeti.mohan@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Previous Negative Biopsy
- Being tested
- Robotic Transperineal Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Transperineal BiopsyProcedure or surgery
Saturation biopsy for previous negative patients
| Study group | Role | What they receive |
|---|---|---|
| Transperineal Biopsy | Experimental | Biopsy of the prostate using transperineal approach Receives: Procedure: Robotic Transperineal Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection
to detect any undetected cancer in Patietns undergoing saturation biopsy
Measured: 2 years
Secondary outcomes (1)
Accuracy and Repeatability
To be accurate in biopsy position (+/- 2mm) and be able to go back to the same position if patient undergoes treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMay 2006
- Primary completionJan 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previous Negative BiopsyStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102361
- Sponsor's protocol ID
- BioXbot
- Acronym
- BxB
- Status last verified
- May 2006
- First submitted
- 11 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prostate Cancer Detection With in House Developed Robot
- ClinicalTrials.gov ID
- NCT01102361
- Acronym / sponsor ID
- BxB / BioXbot
- Conditions
- Previous Negative Biopsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transperineal Biopsy | Experimental | Procedure: Robotic Transperineal BiopsyBiopsy of the prostate using transperineal approach |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Transperineal BiopsySaturation biopsy for previous negative patients | Procedure or surgery | Transperineal Biopsy |
Primary outcome
Cancer Detection
Time frame: 2 years
to detect any undetected cancer in Patietns undergoing saturation biopsy
1 secondary outcome
Accuracy and Repeatability
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
Related trials for Previous Negative Biopsy
Recruiting
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Prostate Cancer Screening, PSMA-PET
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Ho, Doctor contact
Preeti Mohan, Biomedical Engineer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Robotic Transperineal Biopsy in people with Previous Negative Biopsy, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry Ho, Doctor (ho.henry.s.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Detection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2010.