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

TC Erciyes University

Status: Completed

Conditions: Pain Due to Certain Specified Procedures; Biopsy; Prostate Cancer

Treatments: Procedure: Standard transrectal 12 core biopsy; Procedure: MRI- US fusion prostate biopsy (FPB)

Study type: Interventional

Funder types: Other

Identifiers

NCT03859804

2014/508

Details and patient eligibility

About

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).

Full 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).

Enrollment: 252 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Group 1

Experimental group

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

Treatment:

Procedure: MRI- US fusion prostate biopsy (FPB)

Group 2

Active Comparator group

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).

Treatment:

Procedure: Standard transrectal 12 core biopsy