Prostate CancerNCT01752140
A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
A study testing 10-core prostate biopsy protocol and Vienna nomogram prostate biopsy protocol in people with Prostate Cancer, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
Trial summary
In this study, the investigators aim to determine if the Vienna nomogram increases the detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study comparing the Vienna nomogram with a 10-core biopsy protocol. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 10-core prostate biopsy protocol and Vienna nomogram prostate biopsy protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2009to Jul 2010
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PSA elevation
- Abnormal digital rectal examination
- Abnormal findings on prostate imaging
Who cannot join
- Active urinary tract infection
- Documented previous pathological prostatitis
- History of urinary retention
- Recent lower urinary tract surgery
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Urology Department - Hospital de Santa Maria
Lisbon, Lisbon District, 1649-035
About this study
In this study, the investigators aim to determine if the Vienna nomogram increases the detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study comparing the Vienna nomogram with a 10-core biopsy protocol.
Read the detailed description
Trans rectal ultrasound (TRUS) guided prostate biopsy remains the standard for prostate cancer diagnosis. However, the standard protocols miss 15 to 30% of cancers, leading to a variable number of repeat biopsies.
In 2005 the Vienna nomogram was introduced, defining the number of cores to be obtained in a prostate biopsy in relation to age and prostate volume in patients with a serum PSA level of 2-10 ng/mL.
The objective of the study is to determine if the Vienna nomogram increases the detection rate of trans rectal ultrasound guided prostate biopsies, compared to a 10-core biopsy.
This prospective randomized study enrolled men eligible for a prostate biopsy were randomized to a Vienna nomogram protocol or a 10-core protocol. They were further stratified according to age (≤65; >65 and ≤70; >70 years) and prostate volume (≤30; >30 and ≤50; >50 and ≤70; >70 cc).
A subgroup analysis for patients with serum PSA values between 2 and 10 ng/mL was performed.
- Conditions
- Prostate Cancer
- Being tested
- 10-core prostate biopsy protocol, Vienna nomogram prostate biopsy protocol
- Keywords
- Prostate cancer, Prostate biopsy, Vienna nomogram
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-core prostate biopsy protocolProcedure or surgery
Local vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain 10 biopsy cores.
Vienna nomogram prostate biopsy protocolProcedure or surgery
Local vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain a number of cores as defined by the Vienna nomogram.
| Study group | Role | What they receive |
|---|---|---|
| 10-core prostate biopsy protocol group | Active comparator | Ultrasound guided prostate biopsy with extraction of 10 cores Receives: Procedure: 10-core prostate biopsy protocol |
| Vienna nomogram prostate biopsy protocol group | Active comparator | Ultrasound guided prostate biopsy performed according to the Vienna nomogram Receives: Procedure: Vienna nomogram prostate biopsy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer detection rate
Measured: Up to four weeks after intervention
Secondary outcomes (2)
Prostate cancer detection rate in prostate volume and age subclasses
Measured: Up to four weeks after intervention
Gleason score concordance between biopsy and prostatectomy specimens
Measured: Up to four weeks after prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tito Palmela Leitão, Hospital de Santa Maria, Portugal
- Investigators
- Tito P Leitão, Dr., Principal investigator, Hospital de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752140
- Sponsor's protocol ID
- BPTRVienna
- Status last verified
- Dec 2012
- First submitted
- 13 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Uzzo RG, Wei JT, Waldbaum RS, Perlmutter AP, Byrne JC, Vaughan ED Jr. The influence of prostate size on cancer detection. Urology. 1995 Dec;46(6):831-6. doi: 10.1016/s0090-4295(99)80353-7.
PubMed 7502425Djavan B, Margreiter M. Biopsy standards for detection of prostate cancer. World J Urol. 2007 Mar;25(1):11-7. doi: 10.1007/s00345-007-0151-1. Epub 2007 Mar 7.
PubMed 17342490Lecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int. 2011 Jul;108(2):204-8. doi: 10.1111/j.1464-410X.2010.09887.x. Epub 2010 Nov 19.
PubMed 21087452Remzi M, Fong YK, Dobrovits M, Anagnostou T, Seitz C, Waldert M, Harik M, Marihart S, Marberger M, Djavan B. The Vienna nomogram: validation of a novel biopsy strategy defining the optimal number of cores based on patient age and total prostate volume. J Urol. 2005 Oct;174(4 Pt 1):1256-60; discussion 1260-1; author reply 1261. doi: 10.1097/01.ju.0000173924.83392.cc.
PubMed 16145388
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
- ClinicalTrials.gov ID
- NCT01752140
- Acronym / sponsor ID
- BPTRVienna
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate biopsy, Vienna nomogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Dec 2012 (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.
In this study, the investigators aim to determine if the Vienna nomogram increases the detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study comparing the Vienna nomogram with a 10-core biopsy protocol.
Detailed description
Trans rectal ultrasound (TRUS) guided prostate biopsy remains the standard for prostate cancer diagnosis. However, the standard protocols miss 15 to 30% of cancers, leading to a variable number of repeat biopsies.
In 2005 the Vienna nomogram was introduced, defining the number of cores to be obtained in a prostate biopsy in relation to age and prostate volume in patients with a serum PSA level of 2-10 ng/mL.
The objective of the study is to determine if the Vienna nomogram increases the detection rate of trans rectal ultrasound guided prostate biopsies, compared to a 10-core biopsy.
This prospective randomized study enrolled men eligible for a prostate biopsy were randomized to a Vienna nomogram protocol or a 10-core protocol. They were further stratified according to age (≤65; >65 and ≤70; >70 years) and prostate volume (≤30; >30 and ≤50; >50 and ≤70; >70 cc).
A subgroup analysis for patients with serum PSA values between 2 and 10 ng/mL was performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-core prostate biopsy protocol group | Active comparator | Procedure: 10-core prostate biopsy protocolUltrasound guided prostate biopsy with extraction of 10 cores |
| Vienna nomogram prostate biopsy protocol group | Active comparator | Procedure: Vienna nomogram prostate biopsy protocolUltrasound guided prostate biopsy performed according to the Vienna nomogram |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PSA elevation
- Abnormal digital rectal examination
- Abnormal findings on prostate imaging
Key exclusion criteria (4 listed)
- Active urinary tract infection
- Documented previous pathological prostatitis
- History of urinary retention
- Recent lower urinary tract surgery
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 |
|---|---|---|
| 10-core prostate biopsy protocolLocal vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain 10 biopsy cores. | Procedure or surgery | 10-core prostate biopsy protocol group |
| Vienna nomogram prostate biopsy protocolLocal vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain a number of cores as defined by the Vienna nomogram. | Procedure or surgery | Vienna nomogram prostate biopsy protocol group |
Primary outcome
Prostate cancer detection rate
Time frame: Up to four weeks after intervention
2 secondary outcomes
Prostate cancer detection rate in prostate volume and age subclasses
Time frame: Up to four weeks after intervention
Gleason score concordance between biopsy and prostatectomy specimens
Time frame: Up to four weeks after prostatectomy
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 19 Dec 2012.
- Background: PubMed 7502425Uzzo RG, Wei JT, Waldbaum RS, Perlmutter AP, Byrne JC, Vaughan ED Jr. The influence of prostate size on cancer detection. Urology. 1995 Dec;46(6):831-6. doi: 10.1016/s0090-4295(99)80353-7.
- Background: PubMed 17342490Djavan B, Margreiter M. Biopsy standards for detection of prostate cancer. World J Urol. 2007 Mar;25(1):11-7. doi: 10.1007/s00345-007-0151-1. Epub 2007 Mar 7.
- Background: PubMed 21087452Lecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int. 2011 Jul;108(2):204-8. doi: 10.1111/j.1464-410X.2010.09887.x. Epub 2010 Nov 19.
- Background: PubMed 16145388Remzi M, Fong YK, Dobrovits M, Anagnostou T, Seitz C, Waldert M, Harik M, Marihart S, Marberger M, Djavan B. The Vienna nomogram: validation of a novel biopsy strategy defining the optimal number of cores based on patient age and total prostate volume. J Urol. 2005 Oct;174(4 Pt 1):1256-60; discussion 1260-1; author reply 1261. doi: 10.1097/01.ju.0000173924.83392.cc.
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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.
Tito P Leitão, Dr. principal investigator
Hospital de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-core prostate biopsy protocol and Vienna nomogram prostate biopsy protocol in people with Prostate Cancer, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
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 4 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 19 Dec 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 Portugal. 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.
What does the primary outcome measure?
Prostate cancer detection rate (time frame: Up to four weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752140, which also lists 4 linked publications.
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 19 Dec 2012; AzTrials last refreshed its copy on 31 Oct 2026.