NCT04582656

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Koelis · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Targeted microwave ablation	Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Timeline

• Start date: 2021-02-11
• Primary completion: 2025-07-29
• Completion: 2025-08-21
• First posted: 2020-10-09
• Last updated: 2026-04-06

Locations

5 sites across 2 countries: Belgium, France