MP23-05 ASSESSMENT OF PATIENT PERSPECTIVE ON BENEFIT AND RISK (B-R) ASSOCIATED WITH HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) FOR THE ABLATION OF PROSTATE TISSUE IN MEN WITH LOCALIZED PROSTATE CANCER

Abstract

You have accessJournal of UrologyHealth Services Research: Practice Patterns, Quality of Life and Shared Decision Making III (MP23)1 Sep 2021MP23-05 ASSESSMENT OF PATIENT PERSPECTIVE ON BENEFIT AND RISK (B-R) ASSOCIATED WITH HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) FOR THE ABLATION OF PROSTATE TISSUE IN MEN WITH LOCALIZED PROSTATE CANCER Olufemi Babalola, Geoffrey Sonn, Minhaj Siddiqui, and Charles Viviano Olufemi BabalolaOlufemi Babalola More articles by this author , Geoffrey SonnGeoffrey Sonn More articles by this author , Minhaj SiddiquiMinhaj Siddiqui More articles by this author , and Charles VivianoCharles Viviano More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002014.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The FDA cleared HIFU for prostate tissue ablation in 2015. This study aims to explore patient preferences regarding the known benefit and important adverse events associated with HIFU for prostate ablation in men with prostate cancer. METHODS: Eligible subjects were treatment-naïve men with a physician confirmed diagnosis of localized prostate cancer (Gleason 6 or 7). A Discrete Choice Experiment (DCE) was used to evaluate patients’ B-R tradeoffs for prostate HIFU outcomes via an online survey. The outcomes of interest were: erectile dysfunction (ED), urinary incontinence (UI), and biopsy result after treatment. Content was based on a literature review, as well as clinical and regulatory knowledge, of HIFU for prostate ablation. Subjects were asked to choose a preferred treatment option in 9 different choice tasks. Each choice task includes a pair of hypothetical treatment profiles that have similar attributes (outcomes) with varying levels (see figure). RESULTS: 165 subjects with a mean age of 65 completed the survey. Preliminary results show patients are willing to trade off among treatment outcomes. The maximum acceptable risk (MAR) indicates that respondents are willing to accept a 1.59%-point increase in ED for a 1%-point increase in favorable biopsy. The minimum acceptable benefit (MAB) indicates that patients are willing to accept a 0.63%-point increase in favorable biopsy for a 1%-point increase in ED associated with HIFU. In addition, the MAR for UI shows that respondents are willing to accept a 1.86%-point increase in UI for a 1%-point increase in favorable biopsy. The MAB indicates that patients are willing to accept a 0.54%-point increase in favorable biopsy for a 1%-point increase in UI. CONCLUSIONS: Incorporation of patient preference information into device regulatory decision making is one of the strategic goals of the Center for Devices and Radiological Health at the FDA. Our results may help inform design and regulatory decision making for current and future prostate tissue ablation devices with limited benefit data by providing information from the patient perspective. Source of Funding: This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946; U01FD005978) totaling $146,080 with 100 percent funding by FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e402-e402 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Olufemi Babalola More articles by this author Geoffrey Sonn More articles by this author Minhaj Siddiqui More articles by this author Charles Viviano More articles by this author Expand All Advertisement Loading ...