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What is HIFU and Sonablate HIFU?
Clinical Trial Information

There are currently two different types of clinical trials being conducted in the to determine the safety and efficacy of a minimally invasive prostate cancer treatment using high intensity focused ultrasound, also known as HIFU, with the Sonablate® 500. One trial is for patients who have recurrent prostate cancer and the other is for patients who have a primary diagnosis. US HIFU, LLC is the sponsor of the Phase III U.S. clinical trials of the Sonablate 500.

Recurrent Prostate Cancer Clinical Trial

Eligibility—to be considered for the U.S. recurrent trials, candidates must:

  • have been treated with external beam radiation therapy two or more years prior;
  • have low-risk, organ-confined recurrent prostate cancer T1c or T2a;
  • be between the ages of 40 and 85;
  • have a PSA level between 0.5ng/mL and 10ng/mL;
  • have a recent (within six months) prostate biopsy that is positive for cancer.

There is no cost to enroll in the study, nor does it require health insurance.

 Click here to see a list of all the locations of the trial.

There are currently several trial sites that enroll at different rates depending on when the site opened and the status of enrollment.

For more information visit Recurrent HIFU Trial Website.

Primary Prostate Cancer Clinical Trial

Eligibility—to be considered for the U.S. primary trials, candidates must:

  • have T1c or T2c carcinoma of the prostate detected by biopsy;
  • be between 40-75 years of age;
  • have a Gleason score of six or less;
  • have prostate specific antigen (PSA) level of 10 ng/mL or less.

There is no cost to enroll in the study, nor does it require health insurance.

There are currently several trial sites that enroll at different rates depending on when the site opened and the status of enrollment.

Click here to learn more about HIFU trials for prostate cancer at ClinicalTrial.gov.

 
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