An Expanded Access Study of the Exablate Prostate System to Treat Localized Prostate Cancer

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Full Title

A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

Purpose

In this study, men with localized prostate cancer (cancer that is contained within the prostate) may receive treatment with the Exablate® Prostate System. The U.S. Food and Drug Administration (FDA) has approved an Exablate system to treat benign soft tissue tumors of the uterus and bone pain that occurs when cancer has spread to the bones; the use of Exablate treatment for localized prostate cancer is considered investigational.

Guided by magnetic resonance imaging (MRI), Exablate treatment works by focusing ultrasound waves on a small area of tissue. The Exablate system uses real-time MRI data collected during the procedure to monitor the temperature of prostate tissue and accurately pinpoint the cancerous tissue to be treated with focused ultrasound. The ultrasound waves pass into the body, without cutting or breaking the skin, and destroy the precisely targeted area of tissue with very high heat. This process is called ablation or soft tissue ablation. Patients will receive one or two Exablate treatments.

Eligibility

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

  • Patients must have intermediate-risk localized prostate cancer and a PSA of 20 ng/ml or less.
  • Patients may not have previously received any prostate cancer treatment.
  • This study is for men age 50 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Behfar Ehdaie at 646-422-4406.

Protocol

19-426

Investigator

Co-Investigators