Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy

February 27, 2019 updated by: Abdullah Demirtas, TC Erciyes University
The aim of this study was to compare the pain levels in transrectal ultrasound (TRUS)-guided standard 12-core prostate biopsy (SPB) and multiparametric prostate magnetic resonance imaging (MpMRI)-guided fusion prostate biopsy (FPB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study included patients that underwent prostate biopsy under local anesthesia (intrarectal 2% lidocaine gel + periprostatic nerve block) due to suspected prostate cancer. Patients detected with a Prostate Imaging Reporting and Data System score (PIRADS) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) 5 min after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps (1: insertion of the probe into the rectum, 2: probe manipulation, 3: the piercing of the biopsy needle).

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Department of Urology, Ercieys University, Faculty Of Medicine,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Elevated blood prostate specific antigen (PSA) levels according to patients age. PSA >2ng/ml for whom aged between 50-60, and PSA >4ng/ml for whom were above 60 years old
  • Having suspicious digital rectal examination
  • having multi-parametric prostate MRI before prostate biopsy
  • Having MRI defined lesions which were PIRADS - 3 -4-5

Exclusion Criteria:

  • PSA > 50 ng/ml
  • previous negative biopsy
  • neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure,
  • patients underwent biopsy under general anesthesia,
  • having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI
Procedure: MRI- US fusion prostate biopsy (FPB)
FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)
Other Names:
  • Group 1
Active Comparator: Group 2
In Group 2, patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB).
Procedure: Standard transrectal 12 core biopsy
TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral
Other Names:
  • Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To detect painful steps of biopsy procedure by asking patients verbally
Time Frame: Within 5 minutes after biopsy
to ask patients most painful step of procedure that verbally defined them before biopsy as 1: insertion of the probe into the rectum, 2: probe manipulation, and 3: the piercing of the biopsy needle
Within 5 minutes after biopsy
Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient)
Time Frame: Within 5 minutes after prostate biopsy
pain assessment was performed using Visual Analogue Scale (VAS)
Within 5 minutes after prostate biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Abdullah T Demirtaş, MD, Erciyes University Faculty of Medicine Department of Urolgoy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 24, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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