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

2016-01-25 16:38:21 | BioPortfolio

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Localized Prostate Cancer

Intervention

Focal High Intensity Focused Ultrasound (HIFU) treatment

Location

Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon
France
69003

Status

Active, not recruiting

Source

Hospices Civils de Lyon

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-25T16:38:21-0500

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Medical and Biotech [MESH] Definitions

The use of focused, high-frequency sound waves to destroy tissue. It is sometimes used in conjunction with but is distinct from INTERVENTIONAL ULTRASONOGRAPHY.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

The use of HIGH-ENERGY SHOCK WAVES, in the frequency range of 20-60 kHz, to cut through or remove tissue. The tissue fragmentation by ultrasonic surgical instruments is caused by mechanical effects not heat as with HIGH-INTENSITY FOCUSED ULTRASOUND ABLATION.

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