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Single-Session laser combo could simplify prostate cancer care

NCT ID NCT07526675

Disease control Sponsor: Benha University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new approach called Bioblation, which combines a prostate biopsy with laser ablation in a single session under local anesthesia. It is for men with severe urinary symptoms and suspected low- to intermediate-risk prostate cancer. The goal is to see if this one-stop procedure can effectively diagnose and treat the cancer while quickly improving symptoms and reducing the need for multiple procedures.

What this could mean

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

Active substance
laser ablation (Elesta system)
What this could lead to
If successful, this could offer a one-stop procedure to diagnose and treat low-risk prostate cancer while relieving urinary symptoms, reducing the need for multiple separate visits.
What could go wrong
This is a small, early-stage study with only 30 participants and no control group. It may not prove better than standard care, and there are risks like infection, bleeding, or incomplete treatment.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 months and older

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: * Patients with severe Lower Urinary Tract Symptoms (LUTS) meeting the following parameters: 1. IPSS score \> 20 2. Uroflowmetry flow rate \< 10 ml/sec 3. Post-void residual \> 150 cc * Patients most probably having low to favorable intermediate-risk prostate cancer, defined as: 1. PSA level between 4 and 20 ng/ml 2. MP-MRI showing 3 or fewer focal lesions 3. MP-MRI focal lesions measuring \< 1.5 cm * International or visiting patients requiring early return to their home country due to professional or personal commitments, provided they can undergo short-term management and follow-up coordination Exclusion Criteria: * Patient PSA level \> 20 ng/ml * More than 3 focal lesions on MP-MRI * Metastatic prostate cancer * History of lower urinary tract surgery (e.g., TURP, Laser, urinary diversions, artificial urinary sphincter) * History of pelvic radiation therapy or radical pelvic surgery

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms prostate cancer

As listed by the trial registrant

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

Benign prostatic hyperplasia Lower urinary tract symptoms (LUTS) 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

  • Urology Department, Benha University Hospitals

    Banhā, Qalyubia Governorate, 13518, Egypt

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