Scientific Publications by FDA Staff

J Urol 2018 Sep;200(3):512-9

Prostate ablation using high intensity focused ultrasound: the potential role for patient preference information--a literature review.

Babalola O, Lee JT, Viviano C

PURPOSE: The Food and Drug Administration (FDA) recently allowed marketing of two HIFU 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. A review of the safety and effectiveness of HIFU and knowledge regarding patient preferences, such as tolerance for adverse events associated with HIFU ablation of tissue in men with prostate cancer, may inform decision-making for device developers and the FDA. MATERIALS AND METHODS: We searched PubMed and Grey literature including FDA reports for relevant data on: 1. The safety and effectiveness of primary and salvage HIFU treatment for localized prostate cancer in studies performed either within or outside the united states (US), and 2. Patient preference information (PPI) on HIFU-related safety and effectiveness outcomes. RESULTS: We found that there are no HIFU effectiveness data relevant to clinical decision-making such as overall survival or prostate-cancer-specific survival in the US. Long-term effectiveness data from outside the US are sparse and outcomes are variable. We found no patient preference data on HIFU treatment in men with prostate cancer. CONCLUSION: The lack of long term HIFU oncological data in a United States population has brought new challenges to prostate cancer stakeholders including clinicians, patients, and the FDA. PPI from future patient studies on HIFU could provide additional information to patients, clinicians, and current and prospective device developers. In addition, it can be used by regulators in their risk-benefit evaluation for this class of treatment devices.