Clinical trial NCT03859804: Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
Official title: Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Due to Certain Specified Procedures
Prostate Cancer
Biopsy
Keywords: fusion
prostate
biopsy
pain
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 252
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: To detect painful steps of biopsy procedure by asking patients verbally
timeFrame: Within 5 minutes after biopsy
measure: Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient)
timeFrame: Within 5 minutes after prostate biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Department of Urology, Ercieys University, Faculty Of Medicine,
Study officials:
affiliation: Erciyes University Faculty of Medicine Department of Urolgoy
name: Abdullah T Demirtaş, MD
role: PRINCIPAL_INVESTIGATOR
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