CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 750 enrolled
Drug / intervention
20 core-biopsy fragments +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02825225
NCT02825225N/ACompleted
CompareCT.gov

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

University of Nove de Julho·interventional·Posted Jul 7, 2016·Updated Jul 7, 2016

In Brief

A clinical study evaluating 20 core-biopsy fragments and Base and apex local anesthesia for Prostate Cancer and 10 related conditions. Completed, enrolled 750 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate 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
CountriesBrazil
CollaboratorsHospital Brigadeiro UGA V-SP

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2016
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.0 years ago

Interventions

20 core-biopsy fragmentsother

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 anesthesiaprocedure

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.