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Awake and comfortable: new study tests prostate cancer ablation without general anesthesia

NCT ID NCT07412275

Symptom relief Sponsor: Koelis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test whether a focal microwave ablation procedure for localized prostate cancer can be performed under local anesthesia instead of general anesthesia or deep sedation. Twenty eligible patients will undergo the treatment while awake, and researchers will measure how often the procedure is completed without needing to switch to stronger anesthesia. The goal is to see if this approach is feasible, safe, and satisfactory for patients.

What this could mean

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

Active substance
microwave ablation and local anesthesia (lidocaine hydrochloride)
What this could lead to
If successful, this approach could make prostate cancer treatment more comfortable and accessible by avoiding general anesthesia.
What could go wrong
This is a very small feasibility study with only 20 participants, so results may not apply widely. The procedure might still require sedation or general anesthesia for some patients.

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 20 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years 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: * Age\>18 years old * Patient undergoing Koelis TMA® intervention * Patient is suitable for general, local anesthesia as well as sedation * No psychiatric illness that would prevent informed consent or optimal treatment and follow-up * Free, informed and written consent, dated and signed by the patient and the investigator, no later than the day of inclusion and before any examination required by the study. * Patient affiliated to a social security scheme or beneficiary of such a scheme in accordance with the regulations in force. Exclusion Criteria: * Severe illness within the last 6 months before the screening visit, including any of the following: uncontrolled congestive heart failure, uncontrolled angina pectoris, myocardial infarction, stroke. * Ineligibility for a Koelis TMA® intervention * Contraindication to general anesthesia and deep sedation. * Uncontrolled coagulopathies or bleeding disorder * A person already participating in an interventional clinical study. * A person placed under judicial protection, guardianship, or legal supervision and incapable of freely giving informed consent. * Patient detained in an institution by medical or judicial decision.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Localised 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

    2 sites in 2 countries. 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

  • Hôpital Cochin Port Royal

    Paris, 75014, France

  • Institut Jules Bordet

    Brussels, 1070, Belgium

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