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

TC Erciyes University252 enrolled

Overview

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).

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

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

252

Conditions

Pain Due to Certain Specified Procedures Prostate Cancer Biopsy

Interventions

Standard transrectal 12 core biopsyPROCEDURE

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

MRI- US fusion prostate biopsy (FPB)PROCEDURE

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)

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: Within 5 minutes after prostate biopsy

Data from ClinicalTrials.gov

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