Microwave zaps prostate tumors with 3D precision
NCT ID NCT04582656
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 Hide 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.
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.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains