Researchers currently are enrolling men aged 50 and older in a clinical study to compare the safety and effectiveness of two options for treatment of localized prostate cancer. The study is taking place at approximately 27 medical facilities in the United States and Canada.

The overall purpose of this study is to compare results of cryotherapy, a treatment that is already approved by the U.S. Food and Drug Administration (FDA), with results of a procedure that uses high-intensity focused ultrasound (HIFU). This comparison will help researchers understand if HIFU is as safe and effective as cryotherapy. HIFU is not approved for treatment by the FDA.

The study consists of treatment and a 24-month follow-up period. Study participants will be evaluated before treatment, during treatment, and after treatment using clinical and laboratory tests, biopsy assessment, and subject self-assessment. Post-treatment follow-up will be conducted five days after the procedure and then at the following months after the procedure: 1, 3, 6, 9, 12, 15, 18, 21, and 24.

After this follow-up period, participants will continue to be followed through annual visits to the study site until the device obtains clearance or the study is terminated by the sponsor to assess for disease recurrence.

It is important to note that inclusion and exclusion criteria are used to help identify appropriate participants. To be eligible, the disease must be organ-confined and limited to stage T1a, b, or c, or T2a, with a PSA level that is less than 10 and a Gleason score of 6 or less. No exceptions can be made for men who do not fit these criteria. For additional eligibility criteria, click here.

Click here to take the prescreener to see if you may be eligible to participate in the study.

the cure rate is greater than 90 percent, according to the Prostate Cancer Foundation.

Prostate Cancer Organizations:

• Prostate Cancer Foundation
• Canadian Cancer Society