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A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

NCT02825225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2016-07-07

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer
  • Local Anesthesia
  • Prostate-Specific Antigen/Blood
  • Biopsy/Methods
  • Image-guided Biopsy/Methods
  • Prostatic Neoplasms/Diagnosis
  • Prostate/Pathology
  • Prospective Studies
  • Humans
  • Male
  • Ultrasonography, 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.

Sponsors & Collaborators

  • Hospital Brigadeiro UGA V-SP

    collaborator UNKNOWN

  • University of Nove de Julho

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825225 on ClinicalTrials.gov