The Europa Uomo Patient Reported Outcome Study 2.0-Prostate Cancer Patient-reported Outcomes to Support Treatment Decision-making.

BACKGROUND: To further strengthen the voice of patients, Europa Uomo initiated the Europa Uomo Patient Reported Outcome Study 2.0 (EUPROMS 2.0) in October 2021. OBJECTIVE: To collect the self-reported perspective of prostate cancer (PCa) patients on physical and mental well-being after PCa treatment outside a clinical trial setting to inform future fellow patients about the impact of PCa treatment. DESIGN, SETTING, AND PARTICIPANTS: Europa Uomo invited PCa patients to complete a cross-sectional survey including the validated EQ-5D-5L, EORTC-QLQ-C30, and the EPIC-26 questionnaires. Furthermore, the nine-item Shared Decision Making Questionnaire (SDM-Q-9) and diagnostic clinical scenarios were included. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Descriptive statistics was used to assess the demographic and clinical characteristics and to analyze the patient-reported outcome data. RESULTS AND LIMITATIONS: Between October 25, 2021 and January 17, 2022, 3571 men from 30 countries completed the EUPROMS 2.0 survey. The median age of respondents was 70 yr (interquartile range 65-75 yr). Half of the respondents underwent one treatment, most often radical prostatectomy. Men who are treated actively experience lower health-related quality of life than men on active surveillance, mainly regarding sexual function, fatigue, and insomnia. Lower urinary incontinence levels were seen for men who underwent radical prostatectomy (single treatment or in combination with other treatments). Of the respondents, 42% indicated that the determination of the prostate-specific antigen (PSA) value was part of a routine blood test; 25% wanted to undergo screening/early detection for PCa, and 20% indicated that the determination of the PSA value had a clinical reason. CONCLUSIONS: A large sample of 3571 international patients has contributed patient experience after PCa treatment in the EUPROMS 2.0 study, confirming that treatment for PCa mainly affects urinary incontinence, sexual function, fatigue, and insomnia. Such information can be used to direct toward a better patient-doctor relationship, to offer patients ready access to responsible information and a better understanding of their disease and treatment. PATIENT SUMMARY: Through the EUPROMS 2.0 survey, Europa Uomo has strengthened the voice of the patient. Such information can be used to inform future prostate cancer (PCa) patients about the impact of PCa treatment and to engage them in informed and shared decision-making.

Sexual and urinary function in prostate cancer clinical studies and the Europa Uomo Patient Reported Outcome Study: does it match?

BACKGROUND: We aimed to quantify the difference in patient reported outcome (PRO) data between clinical studies and the (patient initiated) EUPROMS study for sexual functioning and urinary incontinence after radical prostatectomy (RP) and external beam radiotherapy (RT). METHODS: Europa Uomo, the patient organization of men with prostate cancer (PCa) in Europe, initiated the EUPROMS study. Data involved 1101 men with PCa treated with RP and 304 patients treated with RT. In a literature search we identified investigator-initiated studies which matched EUPROMS characteristics. The observed scores in the literature were compared to the scores calculated using the EUPROMS-models. Data from EUPROMS was used to develop four regression models for men treated with RP and RT. RESULTS: The time between diagnosis and questionnaire completion was estimated to be 3/4 years for men after RP, and 5 for RT. Eight studies were identified which reported PRO data using the EPIC with comparable follow-up. Large heterogeneity was observed in reported literature. For sexual function, the difference in calculated and observed scores is at most 24 points (range 3-24 points) and differences between studies were less evident; for urinary incontinence, the difference between calculated and observed scores is at most 15 points (range 1.5-15) (4 scores above the MID) and previous studies underreported the actual effect compared to the current study. CONCLUSIONS: Previous clinical investigator studies underreported the actual effect for urinary incontinence compared to the EUPROMS study. Clinicians should be aware of a potential underestimation of the reported PRO in the patient-physician communication.

Europa Uomo Patient Reported Outcome Study (EUPROMS): Descriptive Statistics of a Prostate Cancer Survey from Patients for Patients.

BACKGROUND: Europa Uomo initiated the Europa Uomo Patient Reported Outcome Study (EUPROMS) to collect prostate cancer (PCa) patient-reported outcome (PRO) data as a primary endpoint. OBJECTIVE: To inform future PCa patients about the impact of PCa treatment through self-reported PRO data of fellow patients collected outside a clinical trial setting. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional survey was conducted among PCa patients currently receiving or having received treatment. The EUPROMS survey contained the EQ-5D-5 L (generic health), the EORTC-QLQ-C30 (cancer-specific quality of life (QoL), and the Expanded Prostate cancer Index Composite short form 26 (EPIC-26; prostate-specific health) questionnaires. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Descriptive statistics were used to assess the demographic and clinical characteristics, and to analyze the PROs of EQ-5D-5L, EORTC-QLQ-C30, and EPIC-26. RESULTS AND LIMITATIONS: Between August 21 and November 19, 2019, 2943 men from 24 European countries completed the EUPROMS survey. The median age of the respondents was 71 yr (interquartile range 65-75 yr); 81.9% was living with a spouse. In total, 1937 (65.8%) men underwent a single treatment, and 636 (21.6%), 300 (10.2%), and 70 (2.4%) underwent two, three, and four treatments, respectively. Fatigue scores are highest for men who underwent radiotherapy or chemotherapy. Progression of disease leads to more insomnia. Surgery affects urinary incontinence the most. Self-reported sexual function amounts to 27/100, with the lowest scores being reported for men who underwent surgery and radiotherapy (15/100). Overall, patients who received two or more treatments reported lower scores for all indices. CONCLUSIONS: The EUPROMS survey provided a cross-sectional picture of the current PCa patient population and their reported QoL. Initial treatment is often followed by subsequent treatments, affecting mainly sexual function, as well as fatigue and insomnia. QoL of men undergoing chemotherapy is worse for almost all domains. These data can inform physicians and patients on the true impact of PCa treatment. PATIENT SUMMARY: Patient-reported quality of life in the Europa Uomo Patient Reported Outcome Study (EUPROMS) survey-a more informal setting as compared with clinical trials-reveals that prostate cancer treatment affects mainly sexual function, fatigue, and insomnia.

EAU-EANM-ESTRO-ESUR-SIOG Prostate Cancer Guideline Panel Consensus Statements for Deferred Treatment with Curative Intent for Localised Prostate Cancer from an International Collaborative Study (DETECTIVE Study).

BACKGROUND: There is uncertainty in deferred active treatment (DAT) programmes, regarding patient selection, follow-up and monitoring, reclassification, and which outcome measures should be prioritised. OBJECTIVE: To develop consensus statements for all domains of DAT. DESIGN, SETTING, AND PARTICIPANTS: A protocol-driven, three phase study was undertaken by the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology (SIOG) Prostate Cancer Guideline Panel in conjunction with partner organisations, including the following: (1) a systematic review to describe heterogeneity across all domains; (2) a two-round Delphi survey involving a large, international panel of stakeholders, including healthcare practitioners (HCPs) and patients; and (3) a consensus group meeting attended by stakeholder group representatives. Robust methods regarding what constituted the consensus were strictly followed. RESULTS AND LIMITATIONS: A total of 109 HCPs and 16 patients completed both survey rounds. Of 129 statements in the survey, consensus was achieved in 66 (51%); the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients, where consensus was achieved in additional 27 statements (43%). Overall, 93 statements (72%) achieved consensus in the project. Some uncertainties remained regarding clinically important thresholds for disease extent on biopsy in low-risk disease, and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion. CONCLUSIONS: Consensus statements and the findings are expected to guide and inform routine clinical practice and research, until higher levels of evidence emerge through prospective comparative studies and clinical trials. PATIENT SUMMARY: We undertook a project aimed at standardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them. The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting, in order to achieve agreement (ie, consensus) regarding best practice, which will provide guidance to clinicians and researchers.