The FDA (Food and Drug Administration) recently allowed the marketing of 2 high intensity focused ultrasound devices for prostate tissue ablation indications after previous rejections for a prostate cancer indication due to insufficient data on clinical effectiveness or direct patient benefit. We reviewed the safety and effectiveness of high intensity focused ultrasound and knowledge regarding patient preferences, such as tolerance for adverse events associated with high intensity focused ultrasound ablation of tissue, in men with prostate cancer. This may inform decision making for device developers and the FDA.Materials and Methods:
We searched PubMed® and gray literature, including FDA reports for relevant data on 1) the safety and effectiveness of primary and salvage high intensity focused ultrasound of localized prostate cancer in studies performed in or outside the United States and 2) patient preference information on high intensity focused ultrasound related safety and effectiveness outcomes.Results:
We found no high intensity focused ultrasound effectiveness data relevant to clinical decision making, such as overall or prostate cancer specific survival, in the United States. Long-term effectiveness data from outside the United States were sparse and outcomes varied. We also found no patient preference data on high intensity focused ultrasound treatment in men with prostate cancer.Conclusions:
The lack of long-term high intensity focused ultrasound oncological data in an American population has brought new challenges to prostate cancer stakeholders, including clinicians, patients and the FDA. Patient preference information from future patient studies on high intensity focused ultrasound could provide additional information to patients, clinicians, and current and prospective device developers. In addition, it can be used by regulators in benefit-risk evaluations of this class of treatment devices.