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

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

Sponsors

Lead sponsor: TC Erciyes University

Source TC Erciyes University
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).

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).

Overall Status Completed
Start Date December 1, 2016
Completion Date February 1, 2019
Primary Completion Date January 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
To detect painful steps of biopsy procedure by asking patients verbally Within 5 minutes after biopsy
To detect painful steps of biopsy procedure by asking patients verbally Within 5 minutes after biopsy
To detect painful steps of biopsy procedure by asking patients verbally 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) Within 5 minutes after prostate biopsy
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
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
Enrollment 252
Condition
Intervention

Intervention type: Procedure

Intervention name: Standard transrectal 12 core biopsy

Description: 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

Arm group label: Group 2

Other name: Group 2

Intervention type: Procedure

Intervention name: MRI- US fusion prostate biopsy (FPB)

Description: 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)

Arm group label: Group 1

Other name: Group 1

Eligibility

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

Gender: Male

Minimum age: 50 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Abdullah T Demirtaş, MD Principal Investigator Erciyes University Faculty of Medicine Department of Urolgoy
Location
facility
Department of Urology, Ercieys University, Faculty Of Medicine,
Location Countries

Turkey

Verification Date

February 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: TC Erciyes University

Investigator full name: Abdullah Demirtas

Investigator title: Abdullah Demirtas, Md, Assoc. Prof.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group 1

Arm group type: Experimental

Description: 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

Arm group label: Group 2

Arm group type: Active Comparator

Description: 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).

Patient Data No
Study Design Info

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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov