Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer.

BACKGROUND: Men diagnosed with localised prostate cancer (LPC) wanting curative treatment face a highly preference-sensitive choice between prostatectomy and radiotherapy, which offer similar cure rates but different side effects. This study aims to determine the information, decision-making needs and preferences of men with LPC choosing between robotic prostatectomy and standard external beam or stereotactic radiotherapy. METHODS AND ANALYSIS: This study will be conducted at a large public teaching hospital in Australia offering the choice between robotic prostatectomy and radiotherapy from early 2017. Men (20-30) diagnosed with LPC who want curative treatment and meet criteria for either treatment will be invited to participate. In this mixed-methods study, patients will complete semistructured interviews before and after attending a combined clinic in which they consult a urologist and a radiation oncologist regarding treatment and four questionnaires (one before treatment decision-making and three after) assessing demographic and clinical characteristics, involvement in decision-making, decisional conflict, satisfaction and regret. Combined clinic consultations will also be audio-recorded and clinicians will report their perceptions regarding patients' suitability for, openness to and preferences for each treatment. Qualitative data will be transcribed verbatim and thematically analysed and descriptive statistical analyses will explore quantitative decision-making outcomes, with comparison according to treatment choice. DISCUSSION: Results from this study will inform how to best support men diagnosed with LPC deciding which curative treatment option best suits their needs and may identify the need for and content required in a decision aid to support these men. ETHICS AND DISSEMINATION: All participants will provide written informed consent. Data will be rigorously managed in accordance with national legislation. Results will be disseminated via presentations to both scientific and layperson audiences and publications in peer-reviewed scientific journals.