PHASE III CLINICAL STUDY FOR LOCALIZED PROSTATE CANCER

The Food and Drug Administration (FDA) has granted the Sonablate® 500 a provisional Investigational Device Exemption (IDE), which will allow the device to be used in a multicenter clinical study to collect safety and efficacy data for final FDA approval. The clinical study will use High Intensity Focused Ultrasound (HIFU) for the treatment of low risk, localized (T1c/T2a) prostate cancer with the Sonablate® 500.

WHEN: Enrollment has officially begun for the Phase III study.

WHERE: ALL TRIAL SITES ARE FULLY ENROLLED AT THIS POINT AND NO LONGER ACCEPTING ANY NEW TRIAL SUBJECTS. Please check back later to see if a new site has been announced.

WHO: To qualify for the trial participants must meet the following criteria:

• Have organ-confined prostate cancer stage T1 or T2
• Be between the ages of 40 and 75
• Have a Gleason score of less than or equal to 6
• Have a PSA level less than 10 ng/mL
• Have a recent (within 6 months) prostate biopsy that is positive for cancer cells
• Have a prostate volume of less than 40 cc
• Live within a 200 mile radius of a trial site

HOW to get more information or volunteer for a clinical study: CALL 1-877-874-4389.

** All sites announced so far are already completely enrolled and are not accepting any new trial subjects at this time.

Disclaimer: The SB-500 is under investigation and is not approved for use in the US. Please see the complete information in our Disclaimer page