NCT03859804

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: Male
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pain Due to Certain Specified Procedures
• Prostate Cancer
• Biopsy

Interventions

Type	Name	Description
PROCEDURE	Standard transrectal 12 core biopsy	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
PROCEDURE	MRI- US fusion prostate biopsy (FPB)	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)

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-01-31
• Completion: 2019-02-01
• First posted: 2019-03-01
• Last updated: 2019-03-01

Locations

1 site across 1 country: Turkey (Türkiye)