A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes
NCT ID: NCT02825225
Last Updated: 2016-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
750 participants
INTERVENTIONAL
2012-05-31
2016-06-30
Brief Summary
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Detailed Description
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Considering the epidemiological importance of prostate cancer detection in a continuous aging population, this study protocol was enrolled in a single center high volume urology Brazilian Public Hospital. The patients will be randomized at a 1:1 ratio for the two biopsy schemes and for the two anesthesia templates.The main objective was to compare the detection rate of two different prostate biopsy schemes 20-core versus 12-core prostate biopsy guided by transrectal ultrasound. Secondary objectives were to evaluate pain perception of the two local anesthesia schemes using a validated pain scale. The pain was evaluated using the visual pain scale immediately after the biopsy and one hour after the procedure. The patients were contacted by phone one week after the biopsy to assess the occurrence of any complication. The investigators then compared the major and minor complication rates of 20-core versus 12-core protocol using the Clavien-Dindo scale. In those patients with cancer at the pathologic report that underwent radical prostatectomy, the investigators will also compare the concordance of Gleason score between the biopsy versus surgical specimen according to the biopsy scheme 20-core versus 12-core.
Data was collected since mid 2012 up to june 2016, inclusion and exclusion criteria will be detailed elsewhere. All information was obtained by the main investigator and all procedures were supervised by the main investigator as well.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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20 core-biopsy fragments
Patients submitted to experimental intervention (extended sextant biopsy with 20 cores) compared to current standard biopsy protocol (extended sextant biopsy with 12 cores) guided by transrectal ultrasound.
20 core-biopsy fragments
Using the extended sextant fashion prostate biopsy, this randomized group was submitted to a 20-fragments core-biopsy to evaluate the diagnostic power, pain perception and complications comparative to institution's standard 12 cores.
Base and apex local anesthesia
Using the institution's standard local anesthesia protocol (base injection) as active comparator group, this randomized group was submitted to base and apex local anesthetic application to evaluate tolerability of the procedure, pain perception (with use of previous validated analogue pain scale) and complications.
Base and apex local anesthesia
Patients submitted to experimental intervention in prostate-biopsy anesthetic protocol (prostate base and prostate apex bilateral local anesthetic injection) compared to participants submitted to current standard anesthetic protocol in institution (prostate base bilateral local anesthesia) guided by transrectal ultrasound. guided by transrectal ultrasound.
20 core-biopsy fragments
Using the extended sextant fashion prostate biopsy, this randomized group was submitted to a 20-fragments core-biopsy to evaluate the diagnostic power, pain perception and complications comparative to institution's standard 12 cores.
Base and apex local anesthesia
Using the institution's standard local anesthesia protocol (base injection) as active comparator group, this randomized group was submitted to base and apex local anesthetic application to evaluate tolerability of the procedure, pain perception (with use of previous validated analogue pain scale) and complications.
Interventions
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20 core-biopsy fragments
Using the extended sextant fashion prostate biopsy, this randomized group was submitted to a 20-fragments core-biopsy to evaluate the diagnostic power, pain perception and complications comparative to institution's standard 12 cores.
Base and apex local anesthesia
Using the institution's standard local anesthesia protocol (base injection) as active comparator group, this randomized group was submitted to base and apex local anesthetic application to evaluate tolerability of the procedure, pain perception (with use of previous validated analogue pain scale) and complications.
Eligibility Criteria
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Inclusion Criteria
* Patients signing the consent therm agreeing to participate in the trial
* Exclusive local anesthesia prostate biopsy.
* Exclusive transrectal ultrasound guided prostate biopsy.
Exclusion Criteria
* Magnetic resonance cognitive fusion biopsy.
* Previous treatment with radiation therapy or brachytherapy.
* Previous treatment with focal therapy
* Previous androgen deprivation therapy
30 Years
MALE
No
Sponsors
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Hospital Brigadeiro UGA V-SP
UNKNOWN
University of Nove de Julho
OTHER
Responsible Party
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Jose Pontes Jr
MD PhD
Principal Investigators
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Jose Pontes Jr, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nove de Julho
Locations
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Hospital Brigadeiro UGA V-SP
São Paulo, São Paulo, Brazil
Countries
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References
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Giovannucci E, Liu Y, Platz EA, Stampfer MJ, Willett WC. Risk factors for prostate cancer incidence and progression in the health professionals follow-up study. Int J Cancer. 2007 Oct 1;121(7):1571-8. doi: 10.1002/ijc.22788.
Crawford ED. Epidemiology of prostate cancer. Urology. 2003 Dec 22;62(6 Suppl 1):3-12. doi: 10.1016/j.urology.2003.10.013.
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Zaytoun OM, Jones JS. Prostate cancer detection after a negative prostate biopsy: lessons learnt in the Cleveland Clinic experience. Int J Urol. 2011 Aug;18(8):557-68. doi: 10.1111/j.1442-2042.2011.02798.x. Epub 2011 Jun 21.
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Related Links
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Prostate cancer epidemiology in Brazil.
European society of Urology guidelines on prostate cancer
Other Identifiers
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Prostate biopsy - 01
Identifier Type: -
Identifier Source: org_study_id
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