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High Intensity Focused Ultrasound for the Treatment of Low-Risk, Localized Prostate Cancer

[Protocol 08-016]


Full Title :
INVESTIGATIONAL PLAN EDAP ABLATHERM INTEGRATED IMAGING HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) INDICATED OF LOW RISK, LOCALIZED PROSTATE CANCER
Purpose :

The purpose of this study is to evaluate the safety and effectiveness of Ablatherm® Integrated Imaging High Intensity Focused Ultrasound (HIFU) for the treatment of low-risk, localized prostate cancer.

HIFU is designed to treat localized prostate cancer using ultrasound waves traveling through the rectal wall and focused on the prostate gland. The waves produce intense heat, leading to the destruction of cancerous prostate tissue within the targeted zone without damaging surrounding healthy tissue.

The HIFU procedure is performed on an outpatient basis and takes approximately one and a half to three hours. Patients generally are mobile and can return home the same day, and can return to a normal routine within a few days of having the procedure.

Other centers participating in this study will be performing cryotherapy for prostate cancer treatment, and the results will be compared with the effectiveness of HIFU treatment. Memorial Sloan-Kettering is participating only in the HIFU part of this study.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of low-risk, localized prostate cancer that has not yet been treated with any form of therapy.
  • Patients must have a PSA level of 10 ng/ml or less.
  • Patients must be age 60 or older.

For more information and to inquire about eligibility for this study, please contact Dr. James Eastham at 646-422-4390.

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