NCT02662673

Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance. This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.

Conditions

• Localized Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Focal High Intensity Focused Ultrasound (HIFU) treatment	Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.

Timeline

• Start date: 2014-01-13
• Primary completion: 2016-01-01
• Completion: 2017-02-23
• First posted: 2016-01-25
• Last updated: 2018-02-28

Locations

1 site across 1 country: France