Androgen deprivation therapy in advanced prostate cancer: insights from a real-world patient survey on health-related quality of life and information and communication sources.

PURPOSE: Androgen deprivation therapy (ADT) is a cornerstone treatment for advanced and metastatic prostate cancer. Real-world and patient-reported insights into ADT's impact on health-related quality of life (HRQoL) and communication experiences in healthcare settings remain underexplored. This patient organisation-initiated online survey aimed to assess these aspects. METHODS: Between December 2022 and August 2023, the patient organisation Think Blue Vlaanderen and the AZ Sint-Jan Hospital (Bruges, Belgium) invited ADT-treated patients to participate in a prospective, online, cross-sectional, patient-reported outcome survey. Demographic, clinical, HRQoL (FACT and EPIC-26), communication sources and information modality data were collected. Descriptive statistics and comparative analyses were applied. RESULTS: A total of 276/312 (88.5%) participating patients were on ADT at time of survey administration and completion, with the majority receiving a 3-monthly regimen. Sexual HRQoL was low and narrowly distributed (median (IQR): 16.7 (16.7-16.7)), with 84% of patients having erectile dysfunction (ED). Patients finding their ED problematic were more likely to seek pharmaceutical treatment. Hormonal HRQoL was widely distributed (median (IQR): 65 (45-85)), which improved with prolonged ADT duration. Physically active patients reported less lack of energy, but increased hot flashes. Within consistent FACT-G summary scores (median (IQR): 64.50 (54.75-77.00)), improved emotional wellbeing with prolonged ADT was noted. Multidisciplinary communication and multimodal information provision improved patient satisfaction. CONCLUSION: Patient organisation-initiated surveys offer real-world and patient-reported insights. Patient-tailored HRQoL assessments and longitudinal follow-up, physical activity, and multidisciplinary and multimodal communication approaches are warranted to improve patient-centred care in patients receiving ADT.

Functional outcome after radical prostatectomy in 1313 patients: A single-center study.

OBJECTIVES: To assess the impact of urinary continence and erectile function on the quality of life in men undergoing radical prostatectomy (RP) for prostate cancer (PC), we analyzed the preoperative and 1-year postoperative outcomes of five functional domains and their influencing factors. PATIENTS AND METHODS: In this prospective study, all patients undergoing open or robot-assisted RP between Febuary 2017 and March 2020 in a single academic center were included. Patient-reported outcomes were assessed pre- and 12 months postoperatively using the Expanded Prostate Index Composite (EPIC-26) survey, evaluating continence, irritative/obstructive micturition, gastrointestinal symptoms, sexuality, and overall vitality. We examined the impact of RP on sexual function and urinary continence using multivariable logistic regression models, accounting for patient and tumor characteristics. RESULTS: Overall, 1313 consecutive patients gave consent for study participation and completed both surveys. The median age was 66 years (IQR: 60-70). The majority of patients (n = 601, 46%) had an intermediate risk PC. Robotic RP was performed in 71.6% and nerve-sparing technique in 81% of the cases. The median pre- versus postoperative scores were the following: urinary continence 100 (IQR: 91.8-100) versus 85.5 (64.8-100), irritative micturition 87.5 (IQR: 75-100) versus 93.8 (IQR: 87.5-100), gastrointestinal symptoms the same with 100 (IQR: 95.8-100), vitality 95 (IQR: 80-100) versus 90 (IQR: 75-100), and erectile function 65.3 (IQR: 38.8-87.5) versus 22.2 (IQR: 12.5-48.7), respectively. Age (p < 0.001), risk classification (p = 0.002), and nerve-sparing surgery (p = 0.016) were associated with good sexual function (EPIC-26 score ≥60), while only age (p = 0.001) was statistically significantly associated with good urinary continence (EPIC-26 score ≥80). CONCLUSION: Non-modifiable factors such as age and PC risk classification impact urinary continence and sexual function after RP. Nevertheless, urologic surgeons should further focus on improving nerve-sparing techniques, the only modifiable variable, to reduce the surgery's negative impact on urinary continence and sexual function.

Responsiveness and construct validity of EPIC-26, AQoL-6D and SF-6D following treatment in prostate cancer.

PURPOSE: To assess construct validity and responsiveness of the Expanded Prostate Cancer Index Composite Instrument (EPIC-26) relative to the Short-Form Six-Dimension (SF-6D) and Assessment of Quality of Life 6-Dimension (AQoL-6D) in patients following treatment for prostate cancer. METHODS: Retrospective prostate cancer registry data were used. The SF-6D, AQoL-6D, and EPIC-26 were collected at baseline and one year post treatment. Analyses were based on Spearman's correlation coefficient, Bland-Altman plots and intra-class correlation coefficient, Kruskal Wallis, and Effect Size and the Standardised Response Mean for responsiveness. RESULTS: The study sample was comprised of 1915 patients. Complete case analysis of 3,697 observations showed moderate evidence of convergent validity between EPIC-26 vitality/hormonal domain and AQoL-6D (r = 0.45 and 0.54) and SF-6D (r = 0.52 and 0.56) at both timepoints. Vitality/hormonal domain also showed moderate convergent validity with coping domain of AQoL-6D (r = 0.45 and 0.54) and with role (r = 0.41 and 0.49) and social function (r = 0.47 and 0.50) domains of SF-6D at both timepoints, and with independent living (r = 0.40) and mental health (r = 0.43) of AQoL-6D at one year. EPIC-26 sexual domain had moderate convergent validity with relationship domain (r = 0.42 and 0.41) of AQoL-6D at both timepoints. Both AQoL-6D and SF-6D did not discriminate between age groups and tumour stage at both timepoints but AQoL-6D discriminated between outcomes for different treatments at one year. All EPIC-26 domains discriminated between age groups and treatment at both timepoints. The EPIC-26 was more responsive than AQoL-6D and SF-6D between baseline and one year following treatment. CONCLUSIONS: AQoL-6D can be used in combination with EPIC-26 in place of SF-12. Although EPIC-26 is not utility based, its popularity amongst clinicians and ability to discriminate between disease-specific characteristics and post-treatment outcomes in clinical trials makes it a candidate for use within cost-effectiveness analyses. The generic measure provides a holistic assessment of quality of life and is suitable for generating quality adjusted life years (QALYs).

Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26.

PURPOSE: To assess the validity, reliability, and responsiveness of the Spanish version of the Expanded Prostate cancer Index Composite (EPIC) with 26 items. METHODS: Multicentric longitudinal study of patients diagnosed with localized or locally advanced prostate cancer (any T, any N, M0) treated with active surveillance, surgery, external radiotherapy, or brachytherapy. The EPIC-50 was administered initially to the cohort (n = 324 patients), until it was replaced in November 2019 by the EPIC-26 (n = 543), in both groups before treatment and 12 months after. We assessed confirmatory factor analysis (CFA), reliability with Cronbach's alpha coefficient, criterion validity with the intraclass correlation coefficient (ICC), and responsiveness by testing a priori hypotheses on deterioration effect size (ES). RESULTS: The CFA confirmed the five-domain structure of the EPIC-26 proposed by the original instrument (comparative fit index = 0.95). The agreement between EPIC-50 (gold standard) and EPIC-26 domains was excellent (ICC > 0.90). Cronbach's alpha was > 0.7 in almost all domains, and the floor effect was near zero, although ceiling effect was higher than 50% in urinary incontinence and bowel domains. Hypothesized changes between before and 12 months after treatment were confirmed: ES > 0.8 in both urinary incontinence and sexual domains among patients who underwent surgery; and ES ranging 0.44-0.48 for bowel and sexual domains in patients treated with external radiotherapy. CONCLUSION: The Spanish version of the EPIC-26 has demonstrated adequate metric properties, similar to those of the original version, with acceptable goodness-of-fit indices, good criterion validity, reliability, and responsiveness to detect changes after radical prostatectomy or external radiotherapy.

Patient-reported outcomes after curative treatment for prostate cancer with prostatectomy, primary radiotherapy or salvage radiotherapy.

BACKGROUND: Trials reporting adverse health outcomes (AHOs) in terms of patient-reported outcome measures (PROMs) after contemporary curative treatment of prostate cancer (PC) are hampered by study heterogeneity and lack of new treatment techniques. Particularly, the evidence regarding toxicities after radiotherapy (RT) with the volumetric arc therapy (VMAT) technique is limited, and comparisons between men treated with surgery, primary radiotherapy (PRT) and salvage radiotherapy (SRT) are lacking. The aim of the study was to evaluate change in PROMs 3 months after treatment with robotic-assisted laparoscopic prostatectomy (RALP), PRT and SRT administered with VMAT. MATERIAL AND METHODS: A prospective cohort study of men with PC who received curative treatment at the University Hospital of North Norway between 2012 and 2017 for RALP and between 2016 and 2021 for radiotherapy was conducted. A cohort of 787 men were included; 406 men treated with RALP, 265 received PRT and 116 received SRT. Patients completed the validated PROM instrument EPIC-26 before (pre-treatment) and 3 months after treatment. EPIC-26 domain summary scores (DSSs) were analysed, and changes from pre-treatment to 3 months reported. Changes were deemed clinically relevant if exceeding validated minimally clinically important differences (MCIDs). RESULTS: Men treated with RALP reported clinically relevant declining urinary incontinence DSS (-41.7 (SD 30.7)) and sexual DSS (-46.1 (SD 30.2)). Men who received PRT reported worsened urinary irritative DSS (-5.2 (SD 19.6)), bowel DSS (-8.2 (SD 15.1)) and hormonal DSS (-9.6 (SD 18.2)). Men treated with SRT experienced worsened urinary incontinence DSS (-7.3 (SD 18.2)), urinary irritative DSS (-7.5 (SD 14.0)), bowel DSS (-12.5 (SD 16.1)), sexual DSS (-14.9 (SD 18.9)) and hormonal DSS (-23.8 (SD 20.9)). CONCLUSION: AHOs 3 months after contemporary curative treatment for PC varied according to treatment modality and worsened in all treatment groups, although most in SRT.

Psychometric validation of the German version of the EPIC-26 questionnaire for patients with localized and locally advanced prostate cancer.

PURPOSE: For patients with prostate cancer, validated and reliable instruments are essential for measuring patient-reported outcomes. The aim of this study was to validate the German version of the widely established Expanded Prostate Cancer Index Composite with 26 items (EPIC-26). METHODS: A German translation of the original questionnaire was tested in 3094 patients with localized or locally advanced (any T, any N and M0) prostate cancer with treatment intent (including radical prostatectomy, brachytherapy, active surveillance, watchful waiting). They completed the EPIC-26 questionnaire before treatment. A total of 521 of them also completed a questionnaire 12 months afterward. Internal consistency, sensitivity to change, and construct validity were assessed. RESULTS: The internal consistency of all domains was sufficient (Cronbach's alpha between 0.64 and 0.93). Item-to-scale correlation coefficients showed acceptable associations between items and their domain score (all > 0.30), with the lowest scores for "bloody stools" (r = 0.37) and "breast problems" (r = 0.32). Confirmatory and exploratory factor analysis confirmed the five-dimension structure of the EPIC-26 (comparative fit index 0.95). CONCLUSIONS: Psychometric evaluation suggests that the German version of the EPIC-26 is a well-constructed instrument for measuring patient-reported health-related symptoms in patients with prostate cancer.

A cross-sectional study of current work ability after radical prostatectomy.

BACKGROUND: Work ability represents a person's subjective assessment of current ability to work compared to his lifetime best. Since many men with prostate cancer are retired, work ability represents a more relevant work measure than employment status. The primary aim was to examine the prevalence of men who had high versus moderate/poor current work ability compared to their lifetime best work ability at a mean of 3.0 years after robot-assisted laparoscopic prostatectomy. The secondary aim was to study variables associated with moderate/poor work ability at survey. METHODS: This is a questionnaire-based study of men who had robot-assisted laparoscopic prostatectomy at Oslo University Hospital, Radiumhospitalet between January 2005 and August 2010. Among them 777 responded (79%), 730 reported on current work ability, socio-demographic data, somatic and mental health, and typical adverse effects (the EPIC-26) after prostatectomy. High versus moderate/poor work ability was the primary outcome. Descriptive statistics and logistic regression analyses were applied. RESULTS: The mean age of the sample at survey was 65.5 years (SD 5.9). At survey 42% of the sample reported moderate/poor current work ability and 58% reported high work ability. In multivariable analysis older age at survey, low basic education, comorbidity, poor self-rated health, presence of depression and low EPIC-26 hormonal domain score remained significantly associated with moderate/poor work ability. CONCLUSIONS: Current work ability is a useful measure for the working capacity particularly of retired men. Socio-demographic, cancer-related, health, psychological and typical adverse effect variables were significantly associated with moderate/poor current work ability after robot-assisted laparoscopic prostatectomy, and several health and psychological variables are amenable to identification and treatment by health care providers.

Validation of the Italian version of the abbreviated expanded prostate Cancer index composite (EPIC-26) in men with prostate Cancer.

BACKGROUND: This study aims to validate and evaluate the psychometric properties and reliability of the Italian version of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26), a measure of quality of life (QoL) for prostate cancer patients. METHODS: Two hundred and eighty-four prostate cancer patients completed the Italian version of the EPIC-26 questionnaire at 45 days (T1) and 3 months (T2) after robot-assisted radical prostatectomy (RARP). Psychometric properties were evaluated using structural equation modeling: the goodness of fit of the correlated five-factor model (CFFM) for the EPIC-26 was assessed using the confirmatory factor analysis (CFA), while longitudinal invariance was conducted to assess the ability of the EPIC-26 to measure QoL construct over time. Test-retest reliability was assessed as well by considering intraclass correlations. RESULTS: At T1, the CFFM model displayed a good fit to data. Similarly, the model showed an adequate fit also at T2. Results of the reliability analysis attested the acceptable internal consistency and test-retest reliability of each dimension: all Cronbach's alphas could be classified as acceptable (i.e., above .65) except for low Cronbach's alpha for hormonal dysfunction at T1 (i.e., .638) and urinary irritation at both waves. (i.e., respectively .585 and .518). Finally, psychometric properties were invariant over time and each of the five dimensions of QoL displayed from moderate (all ICCs above .500) to good test-retest reliability (i.e. ICC for urinary incontinence = .764). CONCLUSIONS: Results of the CFA and the measurement invariance analysis demonstrated the validity of the Italian version of the EPIC-26 to assess QoL in prostate cancer patients. Its reliability and good psychometric qualities are well-supported, thus providing a valid tool to assess health-related quality of life and its change over time in prostate cancer patients.

[Urinary incontinence after radical prostatectomy for prostate cancer-data from 17,149 patients from 125 certified centers]. / Harninkontinenz nach radikaler Prostatektomie beim Prostatakarzinom ­ aktuelle Daten von 17.149 Patienten aus 125 zertifizierten Zentren.

BACKGROUND: In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3 guideline recommends informing patients about possible effects of the therapy options, including incontinence. However, only little data on continence from routine care in German-speaking countries after RPE are currently available, which makes it difficult to inform patients. OBJECTIVE: The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care. MATERIALS AND METHODS: Information from the PCO (Prostate Cancer Outcomes) study is used, which was collected between 2016 and 2022 in 125 German Cancer Society (DKG)-certified prostate cancer centers in 17,149 patients using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). Changes in the "incontinence" score before (T0) and 12 months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported. RESULTS: The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93 points at T0 and 73 points 12 months later. At T0, 97% of the patients did not use a pad, compared to 56% at T1. 43% of the patients who did not use a pad before surgery used at least one pad a day 12 months later, while 13% use two or more. The proportion of patients using pads differs by age and risk classification. CONCLUSION: The results provide a comprehensive insight into functional outcome 12 months after RPE and can be taken into account when informing patients.

Precise Prediction of Long-Term Urinary Incontinence after Robot-Assisted Laparoscopic Radical Prostatectomy by Readily Accessible "Everyday" Diagnostics during Post-Surgical Hospitalization.

Aim and Objectives: We aimed to test the predictive value of readily accessible and easily performed post-surgical "bedside tests" on their validity of long-term urinary incontinence (UI) (≥12 months) in patients following robot-assisted laparoscopic radical prostatectomy (RALP). Material and Methods: Patients undergoing RALP between July 2020 and March 2021 were prospectively included and subdivided into two groups based on their pad usage after 12 months (0 vs. ≥1 pad). After catheter removal, patients performed a 1 h pad test, documented the need for pad change in a micturition protocol and received post-voiding residual urine volume ultrasound. Univariate and multivariable analyses were used to demonstrate the predictive value of easily accessible tests applied after catheter removal for UI following RALP. Results: Of 109 patients, 47 (43%) had to use at least one pad (vs. 62 (57%) zero pads) after 12 months. Univariate testing showed a significant difference in urine loss between both groups evaluated by the 1 h pad test performed within 24 h after catheter removal (70% < 10 mL, vs. 30% ≥ 10 mL, p = 0.004) and in the need for pad change within the first 24 h after catheter removal (14% dry pads vs. 86% wet pads, p = 0.003). In multivariable analyses, the combination of both tests (synoptical incontinence score) could be confirmed as an independent predictor for UI after 12 months (p = 0.011). Conclusions: Readily accessible "everyday" diagnostics (pad test/change of pads after catheter removal) following RALP seem to be associated with a higher rate of long-term UI. This finding is crucial since patients with a potentially higher need for patient education and counselling can be identified using these readily accessible tests. This could lead to a higher patient satisfaction and improved outcomes.

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.

Impact of multiparametric magnetic resonance imaging targeted biopsy on functional outcomes in patients following robot-assisted laparoscopic radical prostatectomy.

Introduction: Multiparametric magnetic resonance imaging guided prostate biopsy (mpMRI PBx) leads to a higher rate of successful nerve-sparing in robot-assisted laparoscopic prostatectomy (ns-RALP) for prostate cancer (PCa). This study aimed to evaluate the impact of mpMRI PBx compared to standard ultrasound-guided PBx on functional outcomes focusing on erectile function in patients following ns-RALP. Material and methods: All RALPs performed between 01/2016 and 06/2021 were retrospectively stratified according to (attempted) ns vs. non ns RALPs and were then categorized based on the PBx technique (mpMRI PBx vs. standard PBx). We compared RALP outcomes such as pathological tumor stage, rates of secondary nerve resection (SNR) and positive surgical margin status (PSM). Furthermore, we explored the association between PBx-technique and patient-reported outcomes assessed 12 months after RALP using the prospectively collected 26-item Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. Chi-square tests and logistic regression analysis were conducted. Results: A total of 849 RALPs included 517 (61%) procedures with (attempted) ns. Among these, 37.5% were diagnosed via preoperative mpMRI PBx. Patients with a preoperative standard PBx had a 57% higher association of PSM (p = 0.030) compared to patients with mpMRI PBx and a 24% higher risk of erectile dysfunction (ED) 12 months post RALP (p = 0.025). When ns was attempted, we observed a significantly higher rate of SNR in patients who underwent a standard PBx compared to those who received a mpMRI PBx (50.8% vs. 26.7%, p < 0.001) prior RALP. In comparison, upgrading occurred more often in the standard PBx group (50% vs. 40% mpMRI PBx, p = 0.008). Conclusion: The combination of mpMRI PBx for PCa diagnosis followed by ns-RALP resulted in significantly fewer cases of SNR, better oncological outcomes and reduced incidence of ED 1 year after surgery. This included fewer PSM and a lower rate of postoperative tumor upgrading.

Retzius-sparing robot-assisted radical prostatectomy in a medium size oncological center holds adequate oncological and functional outcomes.

Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) has emerged as a surgical option for patients with prostatic cancer in high-volume centers. The objective is to assess oncological and functional outcomes when implementing RS-RARP in a medium-volume center without previous experience of robotic surgery. This is a prospective observational single-center study. Patients operated between July 2017 and April 2020 were divided into two consecutive groups, A and B, each with 104 patients. The surgeons had prior experience in laparoscopic surgery and underwent robotic training. Positive surgical margin (PSM) status, urinary continence, and erectile function projected by Kaplan-Meier curves, together with patient reported quality of life outcomes at 12 months post-surgery were documented. Median patient age was 63 years (IQR = 59-67), overall PSM rate were 33%, 28% for pT2 disease. Pre-operative values showed no significant difference between both groups. The rate of urinary continence dropped from 81 to 78% (SE = 5.7) (Group A) and from 90 to 72% (SE = 6.3) (Group B) using the International Consultation on Incontinence Questionnaire-Short Form. Baseline sexual function was regained in 41% (Group A) and 47% (Group B) of patients. The median Expanded Prostate Index Composite-26 total score decreased from 86 to 82. These outcomes relate favorably to prior reports. There was a clinically significant decrease in median operative time in the successive groups with post-operative complications occurring in less than 2% of surgical procedures overall. A 12-month follow-up suggests that RS-RARP may be safely introduced in a medium-volume center without previous experience of robotic surgery.

The EPIC-26 domain scores after radical prostatectomy are associated with the personality trait of neuroticism.

PURPOSE: The personality trait of neuroticism represents vulnerability for mental distress to somatic health problems. There are few studies of neuroticism in prostate cancer patients. This study examines the levels of self-reported adverse effects (AEs) after robot-assisted radical prostatectomy (RALP) in Norwegian men with high or low levels of neuroticism. Neuroticism is also compared to relevant factors concerning their associations with various AEs. METHODS: Among 982 men who had RALP at Oslo University Hospital, Radiumhospitalet between 2005 and 2010, 79% responded to a mailed questionnaire in 2011. They rated AEs by completing the EPIC-26 questionnaire, and neuroticism on the Eysenck Personality Questionnaire (EPQ). Men with < 1 year's follow-up, treatment failure, and incomplete EPQ responses were omitted, leaving 524 men for analysis. The EPQ responses were dichotomized into low and high level of neuroticism. Stepwise multivariate linear regression analyses were used for examination of associations with the EPIC-26 domain scores. RESULTS: High neuroticism was reported by 20% (95% CI 17-23%) of the patients. On the EPIC-26 dimensions men with high neuroticism had significantly lower mean scores than men with low neuroticism. Most of these between-group differences were clinically significant. In multivariate regression analyses, high neuroticism contributed significantly to all EPIC-26 domains. CONCLUSION: Increased levels of AEs after RALP are significantly associated with high neuroticism. A short screening test should be added to the current EPIC-26 instrument to identify patients with high neuroticism. In these patients, pre-operative counseling should take into account their risk of increased AE experiences.

Prostatectomy with or without post-operative radiotherapy: long-term adverse effects and quality of life.

BACKGROUND: Few longitudinal studies have compared patient-reported long-term adverse effects after radical prostatectomy (RP) alone and RP followed by radiotherapy (RAD), also analyzing the effect of the development of post-treatment dysfunctions/problems (Symptom Burden) on Health-Related Quality of Life (HRQoL). MATERIAL AND METHODS: After median seven years since RP and six years since post-RP RAD, development of EPIC-26 Domain Summary Scores (DSS Changes) and HRQoL scores (SF-12) since the pre-RP situation were evaluated in respectively 317 prostatectomized men without and in 63 patients with additional post-RP RAD. Post-treatment inter-group differences of the prevalent Symptom Burden and of the DSS Changes were calculated. Multivariable logistic regressions evaluated the associations between DSS Changes and post-treatment impaired HRQoL. RESULTS: Compared to RP alone, post-RP RAD increased the post-treatment Symptom Burden, with least inter-group differences within the urinary irritative/obstructive and bowel domain. No significant inter-group difference emerged for the proportions of men with impaired HRQoL. The odds of impaired HRQoL increased significantly with rising DSS Changes (worsening) within the vitality/hormonal domain. Worsening within urinary incontinence and bowel domains significantly increased the odds of impaired physical QoL. High HRQoL scores before RP reduced the odds of post-treatment impaired HRQoL. Living without a partner and use of androgen deprivation therapy increased this odds. CONSLUSIONS: Post-RP radiotherapy increases post-treatment Symptom Burden with negative, though limited impact on the patient's HRQoL. Counceling before post-RP radiotherapy should cover this possible development, taking into account the patient's social situation.

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.

Comparing bowel and urinary domains of patient-reported quality of life at the end of and 3 months post radiotherapy between intensity-modulated radiotherapy and proton beam therapy for clinically localized prostate cancer.

PURPOSE: To prospectively assess acute differences in patient-reported outcomes in bowel and urinary domains between intensity-modulated radiotherapy (IMRT) and proton beam therapy (PBT) for prostate cancer. METHODS AND MATERIALS: Bowel function (BF), urinary irritative/obstructive symptoms (UO), and urinary incontinence (UI) domains of EPIC-26 were collected in patients with T1-T2 prostate cancer receiving IMRT or PBT at a tertiary cancer center (2015-2018). Mean changes in domain scores were analyzed from pretreatment to the end of and 3 months post-radiotherapy for each modality. A clinically meaningful change was defined as a score change >50% of the baseline standard deviation. RESULTS: A total of 157 patients receiving IMRT and 105 receiving PBT were included. There were no baseline differences in domain scores between cohorts. At the end of radiotherapy, there was significant and clinically meaningful worsening of BF and UO scores for patients receiving either modality. In the BF domain, the IMRT cohort experienced greater decrement (-13.0 vs -6.7, P < .01), and had a higher proportion of patients with clinically meaningful reduction (58.4% vs 39.5%, P = .01), compared to PBT. At 3 months post-radiotherapy, the IMRT group had significant and clinically meaningful worsening of BF (-9.3, P < .001), whereas the change in BF score of the PBT cohort was no longer significant or clinically meaningful (-1.2, P = .25). There were no significant or clinically meaningful changes in UO or UI 3 months post-radiotherapy. CONCLUSIONS: PBT had less acute decrement in BF than IMRT following radiotherapy. There was no difference between the two modalities in UO and UI.

Urinary Morbidity in Men Treated With Stereotactic Body Radiation Therapy (SBRT) for Localized Prostate Cancer Following Transurethral Resection of the Prostate (TURP).

Background: Clinical data suggest that stereotactic body radiation therapy (SBRT) provides similar clinical outcomes as other radiation modalities for prostate cancer. However, data reporting on the safety of SBRT after TURP is limited. Herein, we report our experience using SBRT to deliver hypofractionated radiotherapy in patients with a history of TURP including physician-reported toxicities and patient-reported quality of life. Methods: Forty-seven patients treated with SBRT from 2007 to 2016 at Georgetown University Hospital for localized prostate carcinoma with a history of prior TURP were included in this retrospective analysis. Treatment was delivered using the CyberKnife® (Accuray Incorporated, Sunnyvale, CA) with doses of 35 Gy or 36.25 Gy in 5 fractions without prostatic urethral sparing. Toxicities were recorded and scored using the CTCAE v.4. Cystoscopy findings were retrospectively reviewed. Urinary quality of life data was assessed using the International Prostate Symptom Scoring (IPSS) and Expanded Prostate Cancer Index Composite 26 (EPIC-26). A Wilcoxon signed-rank sum test was used to determine if there was a statistically significant increase or decrease in IPSS or EPIC scores between timepoints. Minimally important differences were calculated by obtaining half the standard deviation at time of start of treatment. Results: Forty-seven patients at a median age of 72 years (range 63-84) received SBRT. The mean follow-up was 4.7 years (range 2-10 years). Late Grade 2 and grade 3 urinary toxicity occurred in 23 (48.9%) and 3 (6.4%) men, respectively. There were no Grade 4 or 5 toxicities. Approximately 51% of patients experienced hematuria following treatment. Mean time to hematuria was 10.5 months. Twenty-five cystoscopies were performed during follow-up and the most common finding was hyperemia, varices of the bladder neck/TURP defect, and/or necrotic tissue in the TURP defect. Baseline urinary QOL composite scores were low, but they did not clinically significantly decline in the first 2 years following treatment. Conclusions: In patients with prior TURP, prostate SBRT was well-tolerated. GU toxicity rates were comparable to similar patients treated with conventionally fractionated radiation therapy. Urinary quality of life was poor at baseline, but did not worsen clinically over time. Stricter dosimetric criteria could potentially improve the rate of high-grade late toxicity, but may increase the risk of peri-urethral recurrence.

Improved patient-reported functional outcomes after nerve-sparing radical prostatectomy by using NeuroSAFE technique.

Purpose: To explore whether prostatectomized men report improved post-operative erectile function and urinary control dependent on the application of intra-operative frozen section examination (NeuroSAFE) during nerve-sparing radical prostatectomies (NS-RPs).Methods: Pre- and post-RP responses to the sexual domain and the urinary incontinence subscale of EPIC-26 were analyzed in 95 and 312 men from a NeuroSAFEGroup (Martini-Klinik, Hamburg, Germany) and a Non-NeuroSAFE Group (Oslo University Hospital, Norway), respectively, undergoing NS-RPs for ≤ cT2 prostate cancer. All patients had intra-prostatic tumors as evaluated by Digital Rectal Examination. Statistical significance in bivariate and multi-variable analyses: p < 0.05.Results: With similar oncological outcomes and not associated with the performance of bilateral or unilateral NS-RP within each group patients from the NeuroSAFE Group had better sexuality outcomes than those from the NonNeuroSAFE Group (p < 0.01). Age and pre-RP sexual function represented significant co-variables. In pre-RP potent men, erectile function was preserved in 74% of men in the NeuroSAFE Group and in 46% in those from the NonNeuroSAFE Group (p < 0.01). Any superior continence-saving effect of NeuroSAFE was limited. The non-randomized small-sized observational study design represents the observations' main limitation.Conclusions: Our study indicates that NeuroSAFE contributes to preservation of post-RP erectile function. If confirmed in a randomized trial the NeuroSAFE should be applied in patients undergoing NS-RP for maximal preservation of post-RP sexual function.

Racial and Ethnic Variation in Health-Related Quality of Life Scores Prior to Prostate Cancer Treatment.

INTRODUCTION: Many men diagnosed with prostate cancer are concerned with how the disease and its course of treatment could affect their health-related quality of life (HRQOL). To aid in the decision-making process on a course of treatment and to better understand how these treatments can affect HRQOL, knowledge of pretreatment HRQOL is essential. AIMS: To assess the racial and ethnic variations in HRQOL scores in men newly diagnosed with prostate cancer before electing a course of treatment. METHODS: Male members of the Kaiser Permanente of Southern California health plan who were newly diagnosed with prostate cancer completed the five-domain specific Expanded Prostate Index Composite-26 (EPIC-26) HRQOL questionnaire from March 1, 2011 through August 31, 2013 (N = 2,579). Domain scores were compared across racial and ethnic subgroups and multiple logistic regression analyses were used to assess the association after adjusting for sociodemographic and clinical characteristics. MAIN OUTCOME MEASURES: The five EPIC-26 domain scores (sexual, bowel, hormonal, urinary incontinence, and urinary irritation and obstruction). RESULTS: Results from the fully adjusted analyses indicated that non-Hispanic black men were more likely to be above the sample median on the sexual (odds ratio [OR] = 1.43, 95% CI = 1.09-1.88), hormonal (OR = 1.35, 95% CI = 1.03-1.77), and urinary irritation and obstruction (OR = 1.34, 95% CI = 1.03-1.74) domains compared with non-Hispanic white men. The Asian or Pacific Islander men were less likely to be above the sample median on the sexual domain (OR = 0.60, 95% CI = 0.44-0.83) compared with non-Hispanic white men. No additional statistically significant differences were identified. CONCLUSIONS: Within an integrated health care organization, we found minimal racial and ethnic differences, aside from sexual function, in pretreatment HRQOL in men newly diagnosed with prostate cancer. These findings provide important insight with which to interpret HRQOL changes in men newly diagnosed with prostate cancer during and after prostate cancer treatment. Reading SR, Porter KR, Slezak JM, et al. Racial and Ethnic Variation in Health-Related Quality of Life Scores Prior to Prostate Cancer Treatment. Sex Med 2017;5:e219-e228.