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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pain Due to Certain Specified Procedures, Prostate Cancer, Biopsy

Intervention / Treatment
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* Procedure: Standard transrectal 12 core biopsy
* Procedure: MRI- US fusion prostate biopsy (FPB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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)<br>* 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)<br>* Other names: Group 1;|
| Active Comparator: Group 2<br>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<br>* 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<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect painful steps of biopsy procedure by asking patients verbally | 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) | pain assessment was performed using Visual Analogue Scale (VAS) | Within 5 minutes after prostate biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fusion, prostate, biopsy, pain