Clinical Impact of the Predict Prostate Risk Communication Tool in Men Newly Diagnosed with Nonmetastatic Prostate Cancer: A Multicentre Randomised Controlled Trial.

Abstract

BACKGROUND\nPredict Prostate is a freely available online personalised risk communication tool for men with nonmetastatic prostate cancer. Its accuracy has been assessed in multiple validation studies, but its clinical impact among patients has not hitherto been assessed.\n\n\nOBJECTIVE\nTo assess the impact of the tool on patient decision-making and disease perception.\n\n\nDESIGN, SETTING, AND PARTICIPANTS\nA multicentre randomised controlled trial was performed across eight UK centres among newly diagnosed men considering either active surveillance or radical treatment. A total of 145 patients were included between 2018 and 2020, with median age 67\xa0yr (interquartile range [IQR] 61-72) and prostate-specific antigen 6.8\xa0ng/ml (IQR 5.1-8.8).\n\n\nINTERVENTION\nParticipants were randomised to either standard of care (SOC) information or SOC and a structured presentation of the Predict Prostate tool.\n\n\nOUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS\nValidated questionnaires were completed by assessing the impact of the tool on decisional conflict, uncertainty, anxiety, and perception of survival.\n\n\nRESULTS AND LIMITATIONS\nMean Decisional Conflict Scale scores were 26% lower in the Predict Prostate group (mean\xa0=\xa016.1) than in the SOC group (mean\xa0=\xa021.7; p\xa0=\xa00.027). Scores on the support , uncertainty , and value clarity subscales all favoured Predict Prostate (all p\xa0<\xa00.05). There was no significant difference in anxiety scores or final treatment selection between the two groups. Patient perception of 15-yr prostate cancer-specific mortality (PCSM) and overall survival benefit from radical treatment were considerably lower and more accurate among men in the Predict Prostate group (p\xa0<\xa00.001). In total, 57% of men reported that the Predict Prostate estimates for PCSM were lower than expected, and 36% reported being less likely to select radical treatment. Over 90% of patients in the intervention group found it useful and 94% would recommend it to others.\n\n\nCONCLUSIONS\nPredict Prostate reduces decisional conflict and uncertainty, and shifts patient perception around prognosis to be more realistic. This randomised trial demonstrates that Predict Prostate can directly inform the complex decision-making process in prostate cancer and is felt to be useful by patients. Future larger trials are warranted to test its impact upon final treatment decisions.\n\n\nPATIENT SUMMARY\nIn this national study, we assessed the impact of an individualised risk communication tool, called Predict Prostate, on patient decision-making after a diagnosis of localised prostate cancer. Men were randomly assigned to two groups, which received either standard counselling and information, or this in addition to a structured presentation of the Predict Prostate tool. Men who saw the tool were less conflicted and uncertain in their decision-making, and recommended the tool highly. Those who saw the tool had more realistic perception about their long-term survival and the potential impact of treatment upon this.\n\n\nTAKE HOME MESSAGE\nThe use of an individualised risk communication tool, such as Predict Prostate, reduces patient decisional conflict and uncertainty when deciding about treatment for nonmetastatic prostate cancer. The tool leads to more realistic perceptions about survival outcomes and prognosis.