NCT03023345

Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 45 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.

Detailed description

In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment. The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally 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 MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).

Conditions

• Low-Risk Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Microwave trans rectal focal treatment	Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration

Timeline

• Start date: 2017-09-12
• Primary completion: 2018-11-05
• Completion: 2019-04-23
• First posted: 2017-01-18
• Last updated: 2025-09-05

Locations

1 site across 1 country: France