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

Not Applicable

Completed

• Conditions: Prostate Cancer; Biopsy; Pain Due to Certain Specified Procedures
• Interventions: Procedure: MRI- US fusion prostate biopsy (FPB); Procedure: Standard transrectal 12 core biopsy

• Registration Number: NCT03859804
• Lead Sponsor: 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).

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2019-01-31
• Status Verified: 2019-02
• Study Completion: 2019-02-01
• Study First Submitted: 2019-02-24
• Study First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Study First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MRI- US fusion prostate biopsy (FPB)	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
Group 2	Standard transrectal 12 core biopsy	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).

Primary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Department of Urology, Ercieys University, Faculty Of Medicine,; 🇹🇷 Kayseri, Turkey