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Prostate CancerVIOLETTENCT04582656

Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

A study testing Targeted microwave ablation in people with Prostate Cancer, run by Koelis at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer. Read more about this study

Who is it for?
Ages 45 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Targeted microwave ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
5 sitesin 2 countries
Study dates
11 Feb 2021to 21 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

France4 sites

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000

  • American Hospital of Paris

    Neuilly-sur-Seine, 92200

  • Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)

    Paris, 75014

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

    Saint-Herblain, 44800

Other trials in France

Belgium1 site

  • Institut Jules Bordet

    Brussels, 1000

Other trials in Belgium

About this study

Official title: Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.

Read the detailed description

European and American guidelines recommend several therapeutic alternatives: radical surgical treatment, external beam radiotherapy or brachytherapy. However, whole-gland treatment induces significant morbidity and burden on quality of life. Targeted treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.

The purpose of this study is to assess the efficacy of a novel ablation treatment using microwaves, delivered transrectally or transperineally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using Organ Based Tracking (OBT) fusion with the TRINITY system (KOELIS, Meylan, France). The same system will be used to identify the index lesion and guide the targeted microwave ablation performed with the TATO3 device (Biomedical Srl, Florence, Italy).

All patients will undergo biopsy at 12 months of follow-up. A biopsy session will also be performed at 6 months, but only for patients with imaging results suspicious for cancer within the ablated area on the mpMRI.

Conditions
Prostate Cancer
Being tested
Targeted microwave ablation
Keywords
Cancer, Prostate, Targeted treatment, Microwave
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted microwave ablationDevice

    Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Study groups in NCT04582656
Study groupRoleWhat they receive
Targeted microwave ablationExperimentalTargeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion
Receives: Device: Targeted microwave ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients with no evidence of cancer on targeted biopsy

    The proportion of patients with no evidence of cancer on targeted biopsy at 12 months, defined by a minimum of 2 targeted core biopsies taken from the index tumor site treated with microwave ablation for focal treatment of intermediate risk prostate cancer

    Measured: 12 months

Secondary outcomes (21)

  1. Proportion of radical salvage treatment

    Proportion of patients undergoing radical salvage treatment of the index lesion

    Measured: 12 months

  2. Time to radical salvage treatment

    Time to radical salvage treatment of the index lesion

    Measured: 12 months

  3. Proportion of patients with any cancer in the untreated area

    Proportion of patients with any cancer in the untreated area, determined by a minimum 12 cores systematic biopsy

    Measured: 12 months

  4. Proportion of patients undergoing treatment for cancer in the untreated area

    Proportion of patients undergoing treatment for cancer in the untreated area and time to treatment

    Measured: 12 months

  5. IPSS questionnaire

    Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS score compared to baseline, score ranging from 0 to 35 (the higher the worse)

    Measured: 7 days and 1, 6 and 12 months

  6. IIEF-5 questionnaire

    Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF-5 score compared to baseline, score ranging from 5 to 25 (the lower the worse)

    Measured: 7 days and 1, 6 and 12 months

  7. MSHQ-EjD-SF questionnaire

    Changes in patients' reported outcome measures (PROMs) for ejaculatory function and bother using MSHQ-EjD-SF score compared to baseline, score ranging from 1 to 15 (the lower the worse) for ejaculatory function and from 0 to 5 for bother/satisfaction (the higher the worse)

    Measured: 7 days and 1, 6 and 12 months

  8. Urine flow

    Change in urine flow, using a uroflowmeter compared to baseline

    Measured: 7 days and 1, 6 and 12 months

  9. Adverse events

    Number and severity of device and procedure related adverse events

    Measured: 12 months

  10. Patient post-operative pain level

    Average patient post-operative pain level reported on a pain numeric rating scale, with a range from 0 (no pain) to 10 (worst pain ever)

    Measured: Treatment day-evaluated between 2 and 4 hours after the procedure

  11. Patient satisfaction

    Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)

    Measured: 1, 6 and 12 months

  12. Ease of the procedure

    Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)

    Measured: Day 1

  13. Duration of the procedure and associated variables

    Duration of the procedure and associated variables

    Measured: Day 1

  14. PSA

    Change in PSA measurement compared to baseline

    Measured: 1, 3, 6, 9 and 12 months

  15. PSA Nadir

    Time to PSA Nadir after treatment of the index lesion

    Measured: 12 months

  16. Prostate volume

    Change in volume of the prostate on the mpMRI compared to baseline

    Measured: 7 days and 6 and 12 months

  17. Patient motivation

    Characterization of patient motivation to undergo targeted microwave ablation for treatment of the index lesion, as assessed by patient questionnaire (no score assigned)

    Measured: Baseline

  18. Surgeon opinion regarding adequate guidance of the microwave ablation needle

    To evaluate the adequate guidance of the microwave ablation needle by the surgeon opinion

    Measured: Day 1

  19. Adequate guidance of the microwave ablation needle on the treated index lesion

    To evaluate the adequate guidance of the microwave ablation needle by percentage of covering of the treated index lesion

    Measured: Day 1

  20. Adequate guidance of the microwave ablation needle on the treated index lesion and margins

    To evaluate the adequate guidance of the microwave ablation needle by percentage of covering of the treated index lesion and margins

    Measured: Day 1

  21. Learning curve of the TMA procedure

    To evaluate the learning curve of the TMA procedure by the duration of the intervention (delay between probe in and the end of anesthesia (minutes).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start11 Feb 2021
  3. Primary completion29 Jul 2025
  4. Study completion21 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, single-arm, open-label, 12-month follow-up clinical trial
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582656
Sponsor's protocol ID
VIOLETTE
Other IDs
2019-A00803-54
Acronym
VIOLETTE
Status last verified
Mar 2026
First submitted
29 Sep 2020
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Delongchamps NB, Peltier A, Potiron E, Bladou F, Diamand R, Messas A, Roche JB, Robert G, Hoepffner JL, Piechaud T, Anract J, Velthoven RV. Targeted microwave ablation of localised prostate cancer (VIOLETTE trial): a prospective multicentre study. BJU Int. 2026 Jun;137(6):1032-1039. doi: 10.1111/bju.70220. Epub 2026 Mar 11.

    PubMed 41810596

Questions about this trial

What is this clinical trial studying?

A study testing Targeted microwave ablation in people with Prostate Cancer, run by Koelis at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with no evidence of cancer on targeted biopsy (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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