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Which prostate biopsy hurts less? new study aims to find out

NCT ID NCT07577895

Knowledge-focused Sponsor: Kayseri Education and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare how much pain men expect versus actually feel during two common prostate biopsy methods: transrectal and transperineal. About 200 men having their first prostate biopsy will rate their pain before and after the procedure. The goal is to help doctors choose the approach that causes less discomfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose the less painful biopsy method for prostate cancer diagnosis, improving patient comfort.
What could go wrong
This is an observational study measuring pain, not testing a treatment. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of male patients with a clinical indication for prostate biopsy, including elevated serum prostate-specific antigen (PSA) levels, abnormal findings on digital rectal examination (DRE), and/or suspicious lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI). Patients will be recruited consecutively from the urology outpatient clinic and will undergo prostate biopsy via either the transrectal or transperineal approach. Only patients undergoing prostate biopsy for the first time, who are able to understand and complete the Visual Analog Scale (VAS) for pain assessment, and who provide written informed consent will be included.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male patients aged 18 years and older Patients with clinical indication for prostate biopsy (elevated serum prostate-specific antigen \[PSA\] level, abnormal digital rectal examination \[DRE\], and/or suspicious lesion on multiparametric prostate magnetic resonance imaging \[mpMRI\]) * Patients undergoing prostate biopsy for the first time * Patients able to understand and complete the Visual Analog Scale (VAS) for pain assessment * Patients who have provided written informed consent to participate in the study Exclusion Criteria: * Patients with a history of previous prostate biopsy * Patients with a previously confirmed diagnosis of prostate cancer * Patients with active urinary tract infection or prostatitis at the time of biopsy * Patients with anorectal pathology that may interfere with the transrectal approach (e.g., anal stenosis, active hemorrhoidal disease, anal fissure, prior rectal surgery) * Patients with perineal pathology that may interfere with the transperineal approach (e.g., perineal infection, scarring, or prior surgery) * Patients with bleeding diathesis or those receiving anticoagulant therapy that cannot be safely discontinued before the procedure * Patients with known allergy or hypersensitivity to local anesthetic agents * Patients with chronic pain syndromes or those receiving regular analgesic or opioid treatment that may affect pain perception * Patients with cognitive impairment, psychiatric disorders, or language barriers preventing reliable use of the Visual Analog Scale (VAS) * Patients who refuse to participate or do not provide informed consent

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Conditions

The condition(s) this trial relates to.

Pain prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kayseri Education and Research Hospital

    Kayseri, Kocasinan, 38080, Turkey (Türkiye)

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