Violette Clinical Trial

Study Presentation


Thanks to improved detection techniques, an early diagnosis of prostate cancer is now more common, leading to the identification of small-volume and less aggressive tumors.

Today, even if several therapeutic alternatives exist, the management of intermediate-risk prostate cancer is still under discussion. Indeed, due to their important impact on quality of life, radical treatments, such as surgery or external radiotherapy, are not suitable for these patients. Radical prostatectomy is correlated to urinary (incontinence) and sexual issues, raising the question of the benefit-risk ratio for patients with less aggressive tumors.

However, an innovative alternative is under investigation. It consists to specifically treat the most aggressive tumor, called the “index tumor”, in order to reduce the progression risk and to avoid a radical treatment. To perform such treatment, it is necessary to localize the tumor and to focus the therapeutic agent on the area which needs to be treated precisely.

Based on this assumption, KOELIS aims to combine tumor localization by MRI and targeted biopsies with image fusion to assess the efficacy of a targeted focal microwave treatment. As such, 65 patients with a localized intermediate-risk prostate cancer are currently being enrolled in a European and multicenter trial, called VIOLETTE. Those patients will then be followed for 12 months after the intervention. More results will be provided at the completion of this study or interim analyses.