Trial reportBJU international2026
Targeted microwave ablation of localised prostate cancer (VIOLETTE trial): a prospective multicentre study.
Trial report in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
Seeing the Unseen: ¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer (The FOCUS-PSMA Study)
Prospective Database / Registry of Focal Therapy for Prostate Cancer
Who cites it
1 citing paper in PubMed.
- Revisiting patient selection and treatment planning in the VIOLETTE trial of targeted microwave ablation.BJU international · 2026Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectiveTo assess the oncological outcomes of targeted microwave ablation (TMA) using organ-based tracking (OBT) Fusion® via KOELIS Trinity® (KOELIS, Meylan, France) in men with intermediate-risk prostate cancer (PCa): the VIOLETTE trial (ClinicalTrials.gov identifier: NCT04582656) PATIENTS AND
methodIn this prospective phase II, multicentre European study, men with a prostate-specific antigen (PSA) level <20 ng/mL, a single magnetic resonance imaging (MRI)-visible lesion ≤15 mm, International Society of Urological Pathology (ISUP) Grade Group 2 on MRI-targeted biopsy, and clinical T stage ≤2, were enrolled. The microwave applicator was placed using OBT Fusion guidance, either transperineally or transrectally. The primary endpoint was the absence of clinically significant PCa (csPCa), defined as ISUP Grade Group ≥2, within the treated area at 12 months. Secondary endpoints included safety, functional outcomes using validated measures, and the need for subsequent radical treatment.
resultsA total of 76 patients were treated across six centres with 66 (87%) completing the 12-month follow-up. At 6 months, six patients had csPCa after positive MRI control, including four within the treated area. At 12 months, csPCa was detected in 15 additional patients, including nine in-field recurrences, yielding an 81% in-field csPCa-free rate. Five serious adverse events in three patients were reported. Sexual (-2.5 points; P < 0.001) and ejaculatory (-1 points; P < 0.001) scores decreased significantly, whereas urinary function remained stable. Radical treatment was required in four (5.2%) patients at 12 months.
conclusionTargeted microwave ablation using OBT Fusion technology appears to be a safe and effective focal therapy procedure for localised intermediate-risk PCa. The VIOLETTE trial achieved its primary endpoint, with 81% patients free of in-field csPCa at 12 months.
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Registered trials
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