Prostate CancerNCT00992615
Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
A study testing prostate biopsy in people with Prostate Cancer, run by Poitiers University Hospital at 1 site in France.
Trial summary
The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- Patients older than 18
- Patients with a PSA value between 3 et 20 ng/ml
- Obtained informed consent
- Patients able to comply with the study protocol
- Patients covered by a social insurance
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie
Poitiers, 86021
About this study
Official title: Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.
- Conditions
- Prostate Cancer
- Being tested
- prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate biopsyProcedure or surgery
prostate cores - 12 or 20
| Study group | Role | What they receive |
|---|---|---|
| Arm 20 cores | Experimental | Not described Receives: Procedure: prostate biopsy |
| arm 12 cores | Active comparator | Not described Receives: Procedure: prostate biopsy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University 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 N/A
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992615
- Sponsor's protocol ID
- BP20-12
- Status last verified
- Nov 2009
- First submitted
- 8 Oct 2009
- Last updated
- 29 Aug 2012
- Results posted
- No
Publications
Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, Mottet N. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol. 2013 Jul;190(1):77-83. doi: 10.1016/j.juro.2012.12.109. Epub 2013 Jan 9.
PubMed 23313205
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00992615
- Acronym / sponsor ID
- BP20-12
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- First posted
- 9 Oct 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 optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 20 cores | Experimental | Procedure: prostate biopsy |
| arm 12 cores | Active comparator | Procedure: prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18
- Patients with a PSA value between 3 et 20 ng/ml
- Obtained informed consent
- Patients able to comply with the study protocol
- Patients covered by a social insurance
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 |
|---|---|---|
| prostate biopsyprostate cores - 12 or 20 | Procedure or surgery | Arm 20 cores, arm 12 cores |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
- Derived from this study: PubMed 23313205Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, Mottet N. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol. 2013 Jul;190(1):77-83. doi: 10.1016/j.juro.2012.12.109. Epub 2013 Jan 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostate biopsy in people with Prostate Cancer, run by Poitiers University Hospital at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 29 Aug 2012. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992615, which also lists 1 linked publication.
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 29 Aug 2012.