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

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ClinicalTrials.gov Identifier: NCT03859804
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University

Study Description
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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
Pain Due to Certain Specified Procedures Prostate Cancer Biopsy Procedure: Standard transrectal 12 core biopsy Procedure: MRI- US fusion prostate biopsy (FPB) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : December 1, 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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 Name: 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 Name: Group 2


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859804


Locations
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Turkey
Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Abdullah T Demirtaş, MD Erciyes University Faculty of Medicine Department of Urolgoy
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Abdullah Demirtas, Abdullah Demirtas, Md, Assoc. Prof., TC Erciyes University
ClinicalTrials.gov Identifier: NCT03859804    
Other Study ID Numbers: 2014/508
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdullah Demirtas, TC Erciyes University:
fusion
prostate
biopsy
pain
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases