Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Microwave zaps prostate tumors with 3D precision

NCT ID NCT04582656

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new way to treat intermediate-risk prostate cancer using a 3D map to guide microwaves directly to the main tumor. 76 men across Europe received the treatment, and researchers checked if the cancer was gone after 12 months. The goal is to destroy the cancer while avoiding damage to healthy tissue, potentially reducing side effects like incontinence and impotence.

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 (device)
What this could lead to
If successful, this could offer a less invasive treatment option for intermediate-risk prostate cancer, potentially reducing side effects compared to surgery or radiation.
What could go wrong
This is a small, single-arm study with only 76 participants and no comparison group. The long-term effectiveness and safety beyond 12 months are unknown.

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

76 people

The number who actually took part.

Started

Feb 2021

Finished

Aug 2025

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

45 to 80 years

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: * Patient aged from 45 to 80 years old * Life expectancy \>10 years at the inclusion time * Patient diagnosed with an intermediate-risk prostate cancer, defined by: * A T1c or T2a clinical stage * A unique cancer focus of Gleason (3+4) (Grade Group 2). In addition to the index lesion intended for treatment, the presence of additional microfoci \< 10mm on mpMRI, for which biopsies present no evidence of cancer or a Gleason score of 3+3, is accepted * A PSA level \<20 ng/mL * Cancer focus identified on a multiparametric MRI of the prostate no more than 3 months before inclusion * Confirmation of the suspicion of cancer identified on the MRI with transrectal or transperineal targeted and systematic biopsies performed with the KOELIS TRINITY system (no more than 3 months before inclusion) * Patient suitable for IV sedation or general anesthesia and focal microwave ablation * No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up * Known coagulopathy or bleeding disorders are controlled * Free, informed and written consent, dated and signed before the enrollment and before any exam required by the trial * Patient affiliated to social security regimen or beneficiary of such regimen for local regions Exclusion Criteria: * Past medical history of prostate surgery * Past medical history of radiotherapy or pelvic trauma * Past medical history of acute prostatitis * Presently taking hormonal manipulation or androgen supplements. * Past medical history of cancer in the 5 previous years, excluding a non-metastatic basal cell carcinoma of the skin * Severe BPH-related urinary tract symptoms, defined by an IPSS score \>18 * Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit * Contraindications for MRI exam * Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasion suspected on prostate MRI * Presence of two or more clinically significant cancer foci in the inclusion biopsy exam * Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4) * Tumor largest axis \>15 mm on the prostate MRI * Distance between the cancer focus and the apex \<5 mm on the prostate MRI * Distance between the cancer focus and the rectum \<5 mm on the prostate MRI * Patient already participating in an interventional clinical trial * Patient protected by law

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Intermediate risk prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • American Hospital of Paris

    Neuilly-sur-Seine, 92200, France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000, France

  • Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)

    Paris, 75014, France

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis

    Saint-Herblain, 44800, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.