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

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT03859804
Collaborator
(none)
252
Enrollment
1
Location
2
Arms
26
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard transrectal 12 core biopsy
  • Procedure: MRI- US fusion prostate biopsy (FPB)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
252 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To detect painful steps of biopsy procedure by asking patients verbally [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

    2. Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient) [Within 5 minutes after prostate biopsy]

      pain assessment was performed using Visual Analogue Scale (VAS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, Ercieys University, Faculty Of Medicine, Kayseri Turkey 38039

    Sponsors and Collaborators

    • TC Erciyes University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdullah Demirtas, Abdullah Demirtas, Md, Assoc. Prof., TC Erciyes University
    ClinicalTrials.gov Identifier:
    NCT03859804
    Other Study ID Numbers:
    • 2014/508
    First Posted:
    Mar 1, 2019
    Last Update Posted:
    Mar 1, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdullah Demirtas, Abdullah Demirtas, Md, Assoc. Prof., TC Erciyes University
    fusion
    prostate
    biopsy
    pain
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Mar 1, 2019