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.

Head-to-head comparison of prostate cancer risk calculators predicting biopsy outcome.

BACKGROUND: Multivariable risk calculators (RCs) predicting prostate cancer (PCa) aim to reduce unnecessary workup (e.g., MRI and biopsy) by selectively identifying those men at risk for PCa or clinically significant PCa (csPCa) (Gleason ≥7). The lack of an adequate comparison makes choosing between RCs difficult for patients, clinicians and guideline developers. We aim to perform a head-to-head comparison of seven well known RCs predicting biopsy outcome. METHODS: Our study comprised 7,119 men from ten independent contemporary cohorts in Europe and Australia, who underwent prostate biopsy between 2007 and 2015. We evaluated the performance of the ERSPC RPCRC, Finne, Chun, ProstataClass, Karakiewicz, Sunnybrook, and PCPT 2.0 (HG) RCs in predicting the presence of any PCa and csPCa. Performance was assessed by discrimination, calibration and net benefit analyses. RESULTS: A total of 3,458 (48%) PCa were detected; 1,784 (25%) men had csPCa. No particular RC stood out predicting any PCa: pooled area under the ROC-curve (AUC) ranged between 0.64 and 0.72. The ERSPC RPCRC had the highest pooled AUC 0.77 (95% CI: 0.73-0.80) when predicting csPCa. Decision curve analysis (DCA) showed limited net benefit in the detection of csPCa, but that can be improved by a simple calibration step. The main limitation is the retrospective design of the study. CONCLUSIONS: No particular RC stands out when predicting biopsy outcome on the presence of any PCa. The ERSPC RPCRC is superior in identifying those men at risk for csPCa. Net benefit analyses show that a multivariate approach before further workup is advisable.

eHealth and mHealth in prostate cancer detection and active surveillance.

eHealth and mobile health (mHealth) offer patients, healthcare providers, researchers, and policy makers new potential to improve wellness, practice prevention and reduce suffering from diseases. While the eHealth market is growing to an expected US $26 billion, its potential in the field of Urology is still underused. Research has shown that currently only 176 apps (of the 300,000 medical apps available) were found in the Apple App Store and Google Play Store, of which 20 were prostate cancer related. Three good examples of eHealth/mHealth applications are the Rotterdam Prostate Cancer Risk Calculator (RPCRC) website and app, the Prostate cancer Research International Active Surveillance (PRIAS) website and the Follow MyPSA app for men on active surveillance for prostate cancer: they are tools with a clear vision that offer true added value in daily clinical practice and which positively influence healthcare beyond borders. To increase the uptake of eHealth applications in the coming years, it is important to involve professionals in their design and development, and to guarantee the safety and privacy of its users and their data.

Prospective evaluation on the effect of interobserver variability of digital rectal examination on the performance of the Rotterdam Prostate Cancer Risk Calculator.

OBJECTIVES: To assess the level of agreement between digital rectal examination findings of two urologists and its effect on risk prediction using the digital rectal examination-based Rotterdam Prostate Cancer Risk Calculator. METHODS: The study sample consisted of a prospective cohort of asymptomatic unscreened men with prostate-specific antigen ≤50.0 ng/mL and transrectal ultrasound volume ≤110 mL who underwent transrectal ultrasound-guided prostate biopsy. Both urologists' digital rectal examination findings were graded normal or abnormal (nodularity and/or induration), and volume classified as 25, 40 or 60 mL, according to the risk calculator algorithm. Interrater agreement analysis using Cohen's kappa (κ) statistic was carried out to determine consistency of digital rectal examination outcome and volume assessment. Receiver operating characteristic curve analysis and calibration plots were constructed to determine the effect of interrater differences. Decision curve analysis was applied to evaluate the clinical usefulness of the model. RESULTS: Of the 241 men included in the study, 41% (n = 98) had prostate cancer (81 were clinically significant, i.e. Gleason ≥3 + 4). There was substantial agreement in the digital rectal examination (abnormal/normal; κ = 0.78; P < 0.001) and volume estimation (κ = 0.79; P < 0.001). Receiver operating characteristic analyses showed good discrimination (0.75-0.78) and were comparable for both urologists. In the high-risk cohort, at a probability threshold of 25%, the risk calculator reduced the prostate biopsy rate by 9%, without missing cancers. CONCLUSIONS: Slight differences in digital rectal examination findings seem to have very limited impact on the performance of the Rotterdam Prostate Cancer Risk Calculator. Therefore, this can be considered a useful prostate biopsy outcome prediction tool.

Rotterdam Prostate Cancer Risk Calculator: Development and Usability Testing of the Mobile Phone App.

BACKGROUND: The use of prostate cancer screening tools that take into account relevant prebiopsy information (ie, risk calculators) is recommended as a way of determining the risk of cancer and the subsequent need for a prostate biopsy. This has the potential to limit prostate cancer overdiagnosis and subsequent overtreatment. mHealth apps are gaining traction in urological practice and are used by both practitioners and patients for a variety of purposes. OBJECTIVE: The impetus of the study was to design, develop, and assess a smartphone app for prostate cancer screening, based on the Rotterdam Prostate Cancer Risk Calculator (RPCRC). METHODS: The results of the Rotterdam arm of the European Randomized Study of Screening for Prostate Cancer (ERSPC) study were used to elaborate several algorithms that allowed the risk of prostate cancer to be estimated. A step-by-step workflow was established to ensure that depending on the available clinical information the most complete risk model of the RPCRC was used. The user interface was designed and then the app was developed as a native app for iOS. The usability of the app was assessed using the Post-Study System Usability Questionnaire (PSSUQ) developed by IBM, in a group of 92 participants comprising urologists, general practitioners, and medical students. RESULTS: A total of 11 questions were built into the app, and, depending on the answers, one of the different algorithms of the RPCRC could be used to predict the risk of prostate cancer and of clinically significant prostate cancer (Gleason score ≥7 and clinical stage >T2b). The system usefulness, information quality, and interface quality scores were high-92% (27.7/30), 87% (26.2/30), and 89% (13.4/15), respectively. No usability problems were identified. CONCLUSIONS: The RPCRC app is helpful in predicting the risk of prostate cancer and, even more importantly, clinically significant prostate cancer. Its algorithms have been externally validated before and the usability score shows the app's interface is well designed. Further usability testing is required in different populations to verify these results and ensure that it is easy to use, to warrant a broad appeal, and to provide better patient care.