Prostate CancerPhase 3BIOPRESNCT00851292
The BIOPRES Trial: Transrectal BIOpsies of the PRostate: End Versus Side-firing
A Phase 3 study testing TRUS probe in people with Prostate Cancer, run by Amphia Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to study the difference in prostate cancer between two prostate biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the prostate is biopsied. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TRUS probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Sep 2012
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PSA and DRE performed in advance of the biopsy
- Informed consent
- Number of biopsy cores according to the volume dependent biopsy protocol (8 cores in prostates with a volume less than 40 mL., 10 in 40-60 mL. and 12 in >60 mL.)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Stijn Roemeling, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amphia hospital
Breda, North Brabant
Stijn Roemeling, MD, PhD
About this study
Official title: The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
The purpose of this study is to study the difference in prostate cancer between two prostate biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the prostate is biopsied.
Read the detailed description
Rationale: Research towards the efficacy of transrectal prostate biopsies has predominantly focused on the amount of biopsy cores. However, variation in the angle of entrance of the biopsy gun has been less studied. It is believed that obtaining biopsy cores by end firing will improve the efficacy, because of an improved sampling of the apical region.
Objectives: To investigate the difference between side and end-firing in transrectal prostate needle biopsies in terms of qualitative and quantitative prostate cancer detection.
Methods: From September 1st 2009 - September 1st 2012, all men with an initial prostate biopsy in a representative, Dutch, general hospital with six participating urologists and two residents will be subjected to a randomized controlled, single blind, single center, diagnostics trial. Men will be randomized for a biopsy using an end-firing or a side-firing probe. The primary endpoint is the prostate cancer detection rate; secondary endpoints are the number of cores invaded with prostate cancer, nomogram for indolent cancer-score, Gleason score, complications and biopsy length.
Expected outcomes: We hypothesize that no differences between the biopsy techniques exist.
- Conditions
- Prostate Cancer
- Being tested
- TRUS probe
- Keywords
- prostate cancer, biopsy, TRUS, diagnosis
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUS probeDevice
end-firing and side-firing vary in the angle in which they sample the prostate
| Study group | Role | What they receive |
|---|---|---|
| Side-firing | Active comparator | prostate biopsies obtained with side-firing probe Receives: Device: TRUS probe |
| End-firing | Active comparator | Not described Receives: Device: TRUS probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of prostate cancer in the tissue obtained by prostate needle biopsy
Measured: This outcome parameter will be available 5 days after the biopsy has been done. E.g. there will be virtually no 'follow-up' period.
Secondary outcomes (5)
Number of cores invaded with prostate cancer
Measured: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Gleason score
Measured: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Complications
Measured: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Biopsy length
Measured: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Nomogram score for indolent prostate cancer
Measured: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stijn Roemeling, MD, PhD, Principal investigator, Amphia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851292
- Sponsor's protocol ID
- ROE-3
- Acronym
- BIOPRES
- Status last verified
- Jun 2011
- First submitted
- 24 Feb 2009
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
- ClinicalTrials.gov ID
- NCT00851292
- Acronym / sponsor ID
- BIOPRES / ROE-3
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, biopsy, TRUS, diagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 25 Feb 2009 (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 purpose of this study is to study the difference in prostate cancer between two prostate biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the prostate is biopsied.
Detailed description
Rationale: Research towards the efficacy of transrectal prostate biopsies has predominantly focused on the amount of biopsy cores. However, variation in the angle of entrance of the biopsy gun has been less studied. It is believed that obtaining biopsy cores by end firing will improve the efficacy, because of an improved sampling of the apical region.
Objectives: To investigate the difference between side and end-firing in transrectal prostate needle biopsies in terms of qualitative and quantitative prostate cancer detection.
Methods: From September 1st 2009 - September 1st 2012, all men with an initial prostate biopsy in a representative, Dutch, general hospital with six participating urologists and two residents will be subjected to a randomized controlled, single blind, single center, diagnostics trial. Men will be randomized for a biopsy using an end-firing or a side-firing probe. The primary endpoint is the prostate cancer detection rate; secondary endpoints are the number of cores invaded with prostate cancer, nomogram for indolent cancer-score, Gleason score, complications and biopsy length.
Expected outcomes: We hypothesize that no differences between the biopsy techniques exist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side-firing | Active comparator | Device: TRUS probeprostate biopsies obtained with side-firing probe |
| End-firing | Active comparator | Device: TRUS probe |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PSA and DRE performed in advance of the biopsy
- Informed consent
- Number of biopsy cores according to the volume dependent biopsy protocol (8 cores in prostates with a volume less than 40 mL., 10 in 40-60 mL. and 12 in >60 mL.)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| TRUS probeend-firing and side-firing vary in the angle in which they sample the prostate | Device | End-firing, Side-firing |
Primary outcome
The presence of prostate cancer in the tissue obtained by prostate needle biopsy
Time frame: This outcome parameter will be available 5 days after the biopsy has been done. E.g. there will be virtually no 'follow-up' period.
5 secondary outcomes
Number of cores invaded with prostate cancer
Time frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Gleason score
Time frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Complications
Time frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Biopsy length
Time frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Nomogram score for indolent prostate cancer
Time frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
Stijn Roemeling, MD, PhD contact
Stijn Roemeling, MD, PhD principal investigator
Amphia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRUS probe in people with Prostate Cancer, run by Amphia Hospital at 1 site in Netherlands.
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 1 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 22 Jun 2011. 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 Netherlands. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Stijn Roemeling, MD, PhD (sroemeling@amphia.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of prostate cancer in the tissue obtained by prostate needle biopsy (time frame: This outcome parameter will be available 5 days after the biopsy has been done. E.g. there will be virtually no 'follow-up' period.). 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 22 Jun 2011.