A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

NACompletedINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Prostate CancerLocal AnesthesiaProstate-Specific Antigen/BloodBiopsy/MethodsImage-guided Biopsy/MethodsProstatic Neoplasms/DiagnosisProstate/PathologyProspective StudiesHumansMaleUltrasonography, Interventional/Methods
Interventions
OTHER

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.

Trial Locations (1)

01401-901

Hospital Brigadeiro UGA V-SP, São Paulo

All Listed Sponsors
collaborator

Hospital Brigadeiro UGA V-SP

UNKNOWN

lead

University of Nove de Julho

OTHER

NCT02825225 - A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes | Biotech Hunter | Biotech Hunter