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

Primary Purpose

Pain Due to Certain Specified Procedures, Prostate Cancer, Biopsy

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Standard transrectal 12 core biopsy

MRI- US fusion prostate biopsy (FPB)

About this trial

This is an interventional supportive care trial for Pain Due to Certain Specified Procedures focused on measuring fusion, prostate, biopsy, pain

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Department of Urology, Ercieys University, Faculty Of Medicine,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm 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

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).

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03859804

First Posted

February 24, 2019

Last Updated

February 27, 2019

Sponsor

TC Erciyes University

1. Study Identification

Unique Protocol Identification Number

NCT03859804

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Due to Certain Specified Procedures, Prostate Cancer, Biopsy

Keywords

fusion, prostate, biopsy, pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

252 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Active Comparator

Arm 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).

Intervention Type

Procedure

Intervention Name(s)

Standard transrectal 12 core biopsy

Other Intervention Name(s)

Group 2

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

MRI- US fusion prostate biopsy (FPB)

Other Intervention Name(s)

Group 1

Intervention Description

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)

Primary Outcome Measure Information:

Title

To detect painful steps of biopsy procedure by asking patients verbally

Description

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

Time Frame

Within 5 minutes after biopsy

Title

Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient)

Description

pain assessment was performed using Visual Analogue Scale (VAS)

Time Frame

Within 5 minutes after prostate biopsy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdullah T Demirtaş, MD

Organizational Affiliation

Erciyes University Faculty of Medicine Department of Urolgoy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Urology, Ercieys University, Faculty Of Medicine,

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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

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