Clinical trial · Interventional
Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
NCT04582656CI-TRIAL-00107316VIOLETTEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted microwave ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Targeted microwave ablation
- description
- Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion
- interventionNames
- Device: Targeted microwave ablation
Primary outcomes (1)
- measure
- The proportion of patients with no evidence of cancer on targeted biopsy
- timeFrame
- 12 months
- description
- 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
Secondary outcomes (21)
- measure
- Proportion of radical salvage treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDelongchamps 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. PMID 41810596