RESUMEN
CONTEXT: Prostate cancer (PCa) is the second most common cancer among men worldwide. Urinary, bowel, and sexual function, as well as hormonal symptoms and health-related quality of life (HRQoL), were prioritised by patients and professionals as part of a core outcome set for localised PCa regardless of treatment type. OBJECTIVE: To systematically review the measurement properties of patient-reported outcome measures (PROMs) used in localised PCa and recommend PROMs for use in routine practice and research settings. EVIDENCE ACQUISITION: The psychometric properties of PROMs measuring functional and HRQoL domains used in randomised controlled trials including patients with localised PCa were assessed according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology. MEDLINE and Embase were searched to identify publications evaluating psychometric properties of the PROMs. The characteristics and methodological quality of the studies included were extracted, tabulated, and assessed according to the COSMIN criteria. EVIDENCE SYNTHESIS: Overall, 27 studies evaluating psychometric properties of the Expanded Prostate Cancer Index Composite (EPIC), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), European Organisation for Research and Treatment of Cancer (EORTC) quality of life core 30 (QLQ-C30) and prostate cancer 25 (QLQ-PR25) modules, International Index of Erectile Function (IIEF), and the 36-item (SF-36) and 12-item Short-Form health survey (SF-12) PROMs were identified and included in the systematic review. EPIC and EORTC QLQ-C30, a general module that assesses patients' physical, psychological, and social functions, were characterised by high internal consistency (Cronbach's α 0.46-0.96 and 0.68-0.94 respectively) but low content validity. EORTC QLQ-PR25, which is primarily designed to assess PCa-specific HRQoL, had moderate content validity and internal consistency (Cronbach's α 0.39-0.87). UCLA-PCI was characterised by moderate content validity and high internal consistency (Cronbach's α 0.21-0.94). However, it does not directly assess hormonal symptoms, whereas EORTC QLQ-PR25 does. CONCLUSION: The tools with the best evidence for psychometric properties and feasibility for use in routine practice and research settings to assess PROMs in patients with localised PCa were EORTC QLQ-C30 and QLQ-PR25. Since EORTC QLQ-C30 is a general module that does not directly assess PCa-specific issues, it should be adopted in conjunction with the QLQ-PR25 module. PATIENT SUMMARY: We reviewed and appraised the measurement properties of patient-reported outcome measure questionnaires used for patients with localised prostate cancer. We found good evidence to suggest that two questionnaires (EORTC QLQ-C30 and QLQ-PR25) can be used to measure urinary, bowel, and sexual functions and health-related quality of life.