TY - JOUR T1 - Unmet needs in non-metastatic castration-resistant prostate cancer from the Japanese patient perspective: a discrete choice experiment JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2021-052471 VL - 11 IS - 8 SP - e052471 AU - Hiroji Uemura AU - Hisashi Matsushima AU - Akira Yokomizo AU - Kazuki Kobayashi AU - Gaku Arai AU - Takefumi Satoh AU - Vince Grillo AU - Yirong Chen AU - Shikha Singh AU - Dianne Athene Ledesma Y1 - 2021/08/01 UR - http://bmjopen.bmj.com/content/11/8/e052471.abstract N2 - Objectives With novel antiandrogen treatments of varying clinical benefits and risks becoming available, this study investigates how patients with castration-resistant prostate cancer (CRPC) value differences in treatment characteristics.Design Cross-sectional observational study.Setting A discrete choice experiment was conducted. Patients chose between two hypothetical non-metastatic CRPC (nmCRPC) treatments defined by six attributes: risk of fatigue, falls or fracture, cognitive impairment, hypertension, rashes as side effects to treatment and extension of time until cancer-related pain occurs.Participants A total of 137 adult male patients with CRPC with no prior experience with chemotherapy and with Eastern Cooperative Oncology Group status 0–1 were recruited. Patients were excluded if they participated in an investigational programme outside of routine clinical practice, had a clinically relevant medical or psychiatric condition, or diagnosis of visceral/other metastases not related to the prostate, or were otherwise deemed ineligible by the referring physician.Primary outcome measures Relative preference weights and relative importance of the attributes was estimated by hierarchical Bayesian logistic regression.Results Among the treatment attributes, ‘risk of cognitive impairment as a side effect of treatment’ was the most important attribute (relative importance (RI) (95% CI): 27.47% (24.80% to 30.14%)), followed by ‘extension of time until cancer-related pain occurs’ (RI (95% CI): 17.87% (15.49% to 20.25%)) and the ‘risk of falls or fracture’ (RI (95% CI): 15.99% (14.73% to 17.25%)). The ‘risk of hypertension as a side effect of treatment’ (RI (95% CI): 13.77% (12.73% to 14.81%)) had similar RI as ‘risk of rashes as a side effect of treatment’ (RI (95% CI): 13.17% (12.15% to 14.19%)), followed by the ‘risk of fatigue as a side effect of treatment’ (RI (95% CI): 11.74% (10.75% to 12.73%)).Conclusions Patients consider the risk of cognitive impairment as a side effect of treatment as the most important attribute in nmCRPC, followed by the extension of time until cancer-related pain occurs, and the risk of falls and fracture. These features should be considered in treatment decision making for nmCRPC in Japan.Availability of the data underlying this publication will be determined later according to Bayer’s commitment to the EFPIA/PhRMA ‘Principles for responsible clinical trial data sharing’. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after 1 January 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymised patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. Data access will be granted to anonymised patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded. ER -