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A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

3 juli 2016 bijgewerkt door: Jose Pontes Jr, University of Nove de Julho

A Randomized Controlled Trial To Assess and Compare the Outcomes of 20-core Versus 12-core Prostate Biopsy

The main purpose is to compare the detection rate of 20-core versus 12-core prostate biopsy. The secondary objective is to evaluate pain perception using a validated scale to compare the analgesia provided by the two different local anesthesia schemes. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different biopsy samplings and two local anesthesia schemes.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Prostate cancer is male's leading solid non-cutaneous tumor, and the second cause of cancer death in western countries. The main risk factors are age (5th decade or more), family history and life-style (low physical activity and occidental dietary habit). Due to it's high incidence and mortality, the screening protocols continue to be supported worldwide by the urologic and oncologic societies. The diagnosis of this disease needs histological evidence that is obtained by prostate biopsy which is indicated when prostate specific antigen (PSA) serum levels are elevated or there is suspicion at digital rectal examination. Actual estimations conclude that more than 200.000 new cases are diagnosed per-year in US and much more patients are submitted to biopsies; turning prostate biopsy a routine medical procedure. In therms of current medical evidence there is controversy in some biopsy aspects. The ideal number of fragments to be obtained is not well established. While twelve core is believed to be the minimum to be sampled, the maximum number is not clear. To ease the estimation of the number of necessary core at biopsy the literature recommend the use of nomograms; they adequate the number of removed fragments according to each individual characteristics such as age, volume, previous biopsy and PSA levels. The prostate biopsy is considered a painful procedure by 96% of patients, therefore it is fundamental to soften the soreness employing some form of anesthesia. There is no consensus regarding the ideal protocol but the local anesthesia with the periprostatic blockade is the most employed worldwide. However there is a controversy related to the site of the injection during the periprostatic block in terms of efficacy: base versus apex or both sites.

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

750

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
      • Sao Paulo, Brazilië, 01401-901
        • Hospital Brigadeiro UGA V-SP

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • Formal indication to prostate biopsy: PSA elevation, positive digital rectal examination of prostate, prostate cancer active surveillance protocols.
  • Patients signing the consent therm agreeing to participate in the trial
  • Exclusive local anesthesia prostate biopsy.
  • Exclusive transrectal ultrasound guided prostate biopsy.

Exclusion Criteria:

  • Transperineal ultrasound guided prostate biopsy
  • Magnetic resonance cognitive fusion biopsy.
  • Previous treatment with radiation therapy or brachytherapy.
  • Previous treatment with focal therapy
  • Previous androgen deprivation therapy

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Procedure: 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.
Experimenteel: 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.
Ander: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with prostate cancer detected.
Tijdsspanne: Through study completion, an average of four years.
Statistical evaluation comparing detection of prostate cancer in 12-core versus 20 cores.
Through study completion, an average of four years.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with complications
Tijdsspanne: Immediate, early (30 minutes) and late (within first week)
Comparison of data between 12 versus 20 core-biopsy and base versus base plus apex anesthesia in therms of complication occurrence.
Immediate, early (30 minutes) and late (within first week)
Core biopsy accuracy.
Tijdsspanne: Through study completion, at time of surgery.
Comparison of cancer positive pathology data between 12 and 20 core-biopsy with their respective radical prostatectomy hole mount pathology specimen (when treatment was indicated).
Through study completion, at time of surgery.
Pain perception using pain analogue scale.
Tijdsspanne: Immediate and early (30 minutes after biopsy).
Compare pain perception of two anesthesia scheme base versus base plus apex using the visual pain analogue scale immediately after the biopsy and 30 minutes later. The investigators will also compared the analgesia of these schemes according to PSA, PSA density, free/total PSA ratio, prostate volume, previous biopsy.
Immediate and early (30 minutes after biopsy).
Number of participants with prostate cancer detected according to PSA value
Tijdsspanne: Through study completion, an average of four years.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to the PSA value.
Through study completion, an average of four years.
Number of participants with prostate cancer detected according to PSA density.
Tijdsspanne: Through study completion, an average of four years.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to the PSA density.
Through study completion, an average of four years.
Number of participants with prostate cancer detected according to free/total PSA ratio.
Tijdsspanne: Through study completion, an average of four years.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to the PSA free/total PSA ratio.
Through study completion, an average of four years.
Number of participants with prostate cancer detected according to prostate volume.
Tijdsspanne: Through study completion, an average of four years.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to prostate volume.
Through study completion, an average of four years.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Nove de Julho

Medewerkers

Hospital Brigadeiro UGA V-SP

Onderzoekers

  • Hoofdonderzoeker: Jose Pontes Jr, MD PhD, University of Nove de Julho

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2012

Primaire voltooiing (Werkelijk)

1 juni 2016

Studie voltooiing (Werkelijk)

1 juni 2016

Studieregistratiedata

Eerst ingediend

26 juni 2016

Eerst ingediend dat voldeed aan de QC-criteria

3 juli 2016

Eerst geplaatst (Schatting)

7 juli 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

7 juli 2016

Laatste update ingediend die voldeed aan QC-criteria

3 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Prostate biopsy - 01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Secrecy will be maintained in observation of ethics committee opinion.

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