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

NCT03859804 | Completed

• 1 other identifier: 2014/508
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain Due to Certain Specified Procedures; Prostate Cancer; Biopsy

Keywords

fusion; prostate; biopsy; pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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)

Group 2

ACTIVE COMPARATOR

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

Interventions

Standard transrectal 12 core biopsy PROCEDURE

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

Also known as: Group 2

Group 2

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)

Also known as: Group 1

Group 1

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (23)

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MeSH Terms

Conditions

Prostatic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdullah T Demirtaş, MD

  Erciyes University Faculty of Medicine Department of Urolgoy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abdullah Demirtas, Md, Assoc. Prof.

Model Details: pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 1, 2019
• Study Start: December 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: February 1, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)