UNITED STATES
Organ Confined Prostate Cancer
Phase I Clinical Trials - under protocols approved by the Food and Drug Administration, have been completed at the Indiana University School of Medicine in Indianapolis, Indiana. The results were submitted to the FDA in May 2005. As shown in Figure 1, the device treats the whole prostate gland by placing overlapping HIFU focal zones under computer control and doctor supervision.
Phase II/III Clinical Trials -
The Food and Drug Administration (FDA) has granted the Sonablate® 500 an Investigational Device Exemption (IDE), that allows the device to be used in a multi-center clinical study to collect safety and efficacy data for final FDA approval. The clinical study uses High Intensity Focused Ultrasound (HIFU) for the treatment of low risk, localized (T1c/T2a) prostate cancer with the Sonablate® 500.
WHEN: The Phase III study has started but we are currently not enrolling patients.
WHERE: We are currently not enrolling patients at this time.
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 (San Antonio, TX) |
HOW to get more information or volunteer for a clinical study: CALL 1-877-874-4389.
The Sonablate® 500 is an investigational device limited by Federal Law to investigational use in the United States.
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