CompletedNot Applicable

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

Turkey (Türkiye)252 participantsStarted 2016-12-01

Plain-language 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).

Who can participate

Age range

50 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To detect painful steps of biopsy procedure by asking patients verbally

Timeframe: 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)

Timeframe: Within 5 minutes after prostate biopsy

Trial details

NCT IDNCT03859804

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-31

View on ClinicalTrials.gov More Pain Due to Certain Specified Procedures trials