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Objective: To determine whether or not decision aid (DA) use influences treatment decisions in patients with low and intermediate risk prostate cancer (PC)., Patients and Methods: In a cluster randomized controlled trial, patients were randomized to either DA use (DA group) or no DA use (control group). Between 2014 and 2016, newly diagnosed patients with low or intermediate risk PC were recruited in 18 hospitals in the Netherlands. DA users had access to a web-based DA that provided general PC information, PC-treatment information, and values clarification exercises to elicit personal preferences towards the treatment options. Control group patients received care as usual. Differences in treatment choice were analysed using multilevel logistic regressions. Differences in eligible treatment options between groups were compared using Pearson Chi-square tests., Results: Informed consent was given by 382 patients (DA group N = 273, control group N = 109). Questionnaire response rate was 88% (N = 336). Active surveillance (AS) was an option for 38%, radical prostatectomy (RP) for 98%, external beam radiotherapy (EBRT) for 88%, and brachytherapy (BT) for 79% of patients. DA users received AS significantly more often than control group. Patients (29 vs 16%, p = 0.01), whereas the latter more often chose BT (29 vs 18%, p < 0.01). No differences were found between groups regarding RP and EBRT. DA users who were not eligible for AS, received surgery more often compared to the control group (53 vs 35%, p = 0.01). Patient and disease characteristics were evenly distributed between groups., Conclusion: DA-using PC patients chose the AS treatment option more often than non-DA-using patients did., (© 2021. The Author(s).)

Purpose: With the increasing interest in treatment decision-making based on risk prediction models, it is essential for clinicians to understand the steps in developing and interpreting such models., Methods: A retrospective registry of 20 Dutch hospitals with data on patients treated for castration-resistant prostate cancer was used to guide clinicians through the steps of developing a prediction model. The model of choice was the Cox proportional hazard model., Results: Using the exemplary dataset several essential steps in prediction modelling are discussed including: coding of predictors, missing values, interaction, model specification and performance. An advanced method for appropriate selection of main effects, e.g. Least Absolute Shrinkage and Selection Operator (LASSO) regression, is described. Furthermore, the assumptions of Cox proportional hazard model are discussed, and how to handle violations of the proportional hazard assumption using time-varying coefficients., Conclusion: This study provides a comprehensive detailed guide to bridge the gap between the statistician and clinician, based on a large dataset of real-world patients treated for castration-resistant prostate cancer.

Objective: To evaluate treatment preferences of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) before and after using a web-based decision aid (DA)., Patients and Methods: Between July 2016 and January 2017 patients were invited to use a web-based LUTS/BPH DA. Treatment preferences (for lifestyle advices, medication or surgery) before and after DA use and responses on values clarification exercises were extracted from the DA., Results: In total, 126 patients were included in the analysis. Thirty-four percent (43/126) had not received any previous treatment and were eligible for (continuation of) lifestyle advices or to start medication, as initial treatment. The other 66% (83/126) did use medication and were eligible, either for continuing medication or to undergo surgery. Before being exposed to the DA, 67 patients (53%) were undecided and 59 patients (47%) indicated an initial treatment preference. Half of the patients who were initially undecided were able to indicate a preference after DA use (34/67, 51%). Of those with an initial preference, 80% (47/59) confirmed their initial preference after DA use. Five out of 7 values clarification exercises used in the DA were discriminative between final treatment preferences. In 79%, the treatment preferred after DA use matched the received treatment. Overall, healthcare providers were positive about DA feasibility., Conclusion: Our findings suggest that a LUTS/BPH DA may help patients to confirm their initial treatment preference and support them in forming a treatment preference if they did not have an initial preference., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Current guidelines for the development of decision aids recommend that they have to include a process for helping patients clarify their personal values, for example, by using values clarification methods. In this article, we extensively described the development process of the web-based values clarification method for patients with localized low- to intermediate-risk prostate cancer based on the analytic hierarchy process. With analytic hierarchy process, the relative importance of different attributes of available treatments can be determined through series of pairwise comparisons of potential outcomes. Furthermore, analytic hierarchy process is able to use this information to present respondents with a quantitative overall treatment score and can therefore give actual treatment advice upon patients' request. The addition of this values clarification method to an existing web-based treatment decision aid for patients with localized prostate cancer is thought to improve the support offered to patients in their decision-making process and their decision quality.

Background: Given the major changes in internet use for health communication, the objective of the current study was to compare the internet use and wishes of cancer survivors between 2005 and 2017., Methods: The authors drew a sample of 390 patients in 2005 and 539 patients in 2017 who were diagnosed with breast (128 patients in 2005 and 143 patients in 2017), prostate (96 patients in 2005 and 126 patients in 2017), or gynecologic (89 patients in 2005 and 188 patients in 2017) cancer or lymphoma (77 patients in 2005 and 82 patients in 2017) in 4 different hospitals for the periods 2002 through 2004 and 2014 through 2016. These patients were sent a paper-based questionnaire that contained 45 questions regarding demographics and 4 functions of internet use: content, communication, community, and e-health., Results: The response in 2017 (53%) was lower than that in 2005 (75%). Survivors browsed the internet most frequently to search for information regarding cancer shortly after being diagnosed and while waiting for treatment. There was little change noted with regard to the relative importance attached to the various subjects. In 2017, significant increases were evident with regard to finances (+33%), health care insurance (+29%), and genetics and/or heritability (+27%). The wishes expressed in 2005 by patients were realized in part in 2017., Conclusions: A significant sample of cancer survivors in the Netherlands have indicated that the internet is an important source of information regarding their illness. However, little change was evident over the past 15 years with regard to patients' priorities regarding their wishes for internet use. The wishes of users in 2005 were found to accurately reflect the internet use of the majority of patients in 2017. The results of the current study support the belief that health care professionals should expand their online services and tailor them toward the needs and wishes of their patients., (© 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.)

Background: Practice guidelines hardly recommend herbal extracts for male lower urinary tract symptoms (LUTS). However, many patients are unsatisfied with first-line synthetic drugs and often prefer herbal medicines because of good tolerability. To improve the decision-making process, which should consider the patients' expectations, it is crucial to reflect on the role of phytotherapy in the treatment of LUTS. We (panel experts) reflected on current guideline recommendations and real practice across various European countries and debated the potential role of plant extracts with a focus on pumpkin seed soft extract investigated over 12 months in two randomised placebo-controlled trials., Summary: Most guidelines give no clear recommendations on phytotherapy due to the heterogeneity of clinically investigated extracts. Nevertheless, plant extracts are prescribed to patients with mild-to-moderate LUTS. Also, self-medicating patients often handle their complaints with herbal products. Many patients aim to avoid synthetic drugs for fear of sexual functional side effects and a negative impact on their quality of life. For the elderly, vasoactive comedications might become an issue. When taking plant extracts, patients experience an acceptable symptomatic relief similar to that achieved with synthetics but without side effects. Key Messages: In shared decision-making for purely symptomatic treatment, a low risk of side effects takes priority. We propose to consider patient preferences in the treatment of mild-to-moderate LUTS in men with a low risk of disease progression. We found a consensus that pumpkin seed soft extract adds to the therapeutic armamentarium for patients who cannot or do not want to apply synthetic drugs., (© 2019 S. Karger AG, Basel.)

Implementation of patient's decision aids in routine clinical care is generally low. This study evaluated uptake and usage of a novel Dutch web-based prostate cancer treatment decision aid within the Prostate Cancer Patient Centered Care trial. From an estimated total patient sample of 1006 patients, 351 received a decision aid (35% implementation rate; hospital ranges 16%-84%). After receipt of the decision aid, most patients accessed the decision aid, utilized most functions, although not completely, and discussed the decision aid summary in a subsequent consultation with their care provider. Including nurses for dissemination of decision aids seemed to positively affect decision aid uptake. Once received, patients seemed able to use the decision aid and engage in shared decision-making as intended; however, decision aid uptake and complete usage of all decision aid components should be further improved. Prior to the diagnosis consultation, handing out of the decision aid should be prepared.

Many new decision aids are developed while aspects of existing decision aids could also be useful, leading to a sub-optimal use of resources. To support treatment decision-making in prostate cancer patients, a pre-existing evidence-based Canadian decision aid was adjusted to Dutch clinical setting. After analyses of the original decision aid and routines in Dutch prostate cancer care, adjustments to the decision aid structure and content were made. Subsequent usability testing (N = 11) resulted in 212 comments. Care providers mainly provided feedback on medical content, and patients commented most on usability and summary layout. All participants reported that the decision aid was comprehensible and well-structured and would recommend decision aid use. After usability testing, final adjustments to the decision aid were made. The presented methods could be useful for cultural adaptation of pre-existing tools into other languages and settings, ensuring optimal usage of previous scientific and practical efforts and allowing for a global, incremental decision aid development process.

Objectives: To evaluate the effectiveness of a web-based decision aid (DA), with values clarification exercises compared with usual care, for men with lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH)., Patients and Methods: Between July 2016 and January 2017, all new patients with LUTS/BPH who consulted the urologist were invited to use the DA and participate in this prospective questionnaire study. Patients who consulted the urologist between December 2015 and February 2016 served as controls. The DA was designed to support patients in making a well-informed treatment decision, corresponding with their personal preferences and values. Well-informed decision was measured by using a knowledge questionnaire. Value congruent decision was measured by the correspondence between responses on nine value statements and chosen treatment. The primary outcome, decision quality, was defined as the combination of well-informed decision and value congruent decision. Secondary outcomes were decisional conflict, involvement and received role in shared decision-making, decisional regret, and treatment choice., Results: A total of 109 DA-users and 108 controls were included. DA-users were younger (68.4 vs 71.5 years; P = 0.003) and their education level was higher (P = 0.047) compared with the controls. Patients who used the DA made a well-informed and value congruent decision more often than the control group (43% vs 21%; P = 0.028). DA-users had less decisional conflict (score 33.2 vs 46.6; P = 0.003), experienced a less passive role in decision-making (22% vs 41%; P = 0.038), and reported less process regret (score 2.4 vs 2.8; P = 0.034). Furthermore, DA-users who had not used prior medication chose lifestyle advices more often than the control group (43% vs 11%; P = 0.002). Outcomes were adjusted for significantly different baseline characteristics., Conclusion: The LUTS/BPH DA seems to improve the decision quality by supporting patients in making more well-informed and value congruent treatment decisions. Therefore, further implementation of this DA into routine care is suggested., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Objective: To evaluate perspectives of the multidisciplinary team concerning shared decision-making (SDM) in treatment decisions for older patients with metastatic castration-resistant prostate cancer (mCRPC)., Materials and Methods: A survey among Dutch healthcare providers was conducted to assess healthcare providers' perspectives on patient involvement in decision-making and the value of a decision aid (DA) in the decision-making process. Treatment recommendations were assessed using hypothetical cases in which providers were asked to evaluate their likelihood of pursuing listed treatment options., Results: In total, 170 Dutch healthcare providers, including 82 urologists, 31 oncologists, and 57 oncology nurses completed the survey. Sixty-two percent of urologists, 65% of oncologists, and 51% of oncology nurses found that mCRPC patients take a passive role in decision-making and delegate treatment decisions to doctors due to advanced age (p = .45). Yet, 70% of urologists, 71% of oncologists, and 63% of oncology nurses agreed that mCRPC patients should be always involved in decision-making (p = .91). Fifty-two percent of urologists and 55% of oncologists stated that they are inadequately trained to apply SDM in clinical practice. Conversely, only 20% of oncology nurses believed that oncology nurses are inadequately trained. Fifty-four percent of all providers considered a DA suitable to support these patients and their healthcare providers in the decision-making process. All hypothetical cases showed variation in treatment recommendations among providers, with each of the five treatments ranging from extremely likely to extremely unlikely., Conclusions: The wide variation of treatment recommendations observed among the multidisciplinary team suggests that mCRPC patients and their healthcare providers may benefit from implementation of informed SDM. Given the perceived passive role of older patients with mCRPC in decision-making, interventions to engage them are needed. With slightly more than half of respondents finding DAs useful to facilitate the decision-making process, development and implementation of a DA would be an interesting field of research., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To investigate the effect of including an online decision aid (DA) during prostate cancer treatment counseling on decisional regret and information satisfaction in a one-year follow-up., Methods: Within a cluster RCT, 18 Dutch hospitals were randomized to DA counseling or care-as-usual, patients (n = 382) initially completed questionnaires directly after treatment decision making. Six and twelve months later regret (Decisional Regret Scale) and information satisfaction (SCIP-B) were assessed. Anxious and depressive symptoms (HADS) was included as possible covariate., Results: After 12 months, 43 participants (15%) regretted their treatment choice and 105 participants (36%) were dissatisfied with the information that was received at the time of decision-making, regardless of being exposed to the DA. Anxious and depressive symptoms at follow-up were associated with regret and information dissatisfaction., Conclusion: No long-term benefical effects emerged from DA usage compared to patients who underwent standard counseling., Practice Implications: During PCa treatment counseling, healthcare providers should be aware of anxious and depressive symptoms., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Purpose: To compare patients' evaluation of the treatment decision-making process in localized prostate cancer between counseling that included an online decision aid (DA) and standard counseling., Methods: Eighteen Dutch hospitals were randomized to DA counseling (n = 235) or the control group with standard counseling (n = 101) in a pragmatic, cluster randomized controlled trial. The DA was provided to patients at, or soon after diagnosis. Decisional conflict, involvement, knowledge, and satisfaction with information were assessed with a questionnaire after treatment decision-making. Anxiety and depression served as covariates., Results: The levels of decision involvement and conflict were comparable between patients in both groups. Patients with a DA felt more knowledgeable but scored equally well on a knowledge test as patients without a DA. Small significant negative effects were found on satisfaction with information and preparation for decision-making. A preference for print over online and depression and anxiety symptoms was negatively associated with satisfaction and conflict scores in the DA group., Discussion: The DA aimed to support shared decision-making, while outcomes for a majority of DA users were comparable to patients who received standard counseling. Patients, who are less comfortable with the online DA format or experience anxiety or depression symptoms, could require more guidance toward shared decision-making. To evaluate long-term DA effects, follow-up evaluation on treatment satisfaction and decisional regret will be done.

Objective: The objective of this study is to test if patients' health-related quality of life (HRQoL) declines after prostate biopsy to detect Pca, and after subsequent treatment decision-making in case Pca is confirmed, and to test whether personality state and traits are associated with these potential changes in HRQoL., Methods: Patients who were scheduled for prostate biopsy to detect Pca (N = 377) filled out a baseline questionnaire about HRQoL (EORTC QLQ-C30 and PR25), "big five" personality traits (BFI-10), optimism (LOT-r), and self-efficacy (Decision Self-efficacy Scale) (t0). Patients with confirmed Pca (N = 126) filled out a follow-up questionnaire on HRQoL within 2 weeks after treatment was chosen but had not yet started (t1)., Results: HRQoL declined between t0 and t1, reflected in impaired role and cognitive functioning, and elevated fatigue, constipation, and prostate-specific symptoms. Sexual activity and functioning improved. Baseline HRQoL scores were unrelated to the selection of a particular treatment, but for patients who chose a curative treatment, post-decision HRQoL showed a greater decline compared to patients who chose active surveillance. Optimism was associated with HRQoL at baseline; decisional self-efficacy was positively associated with HRQoL at follow-up. No associations between HRQoL and the "big five" personality traits were found., Conclusion: Patients who have undergone prostate biopsy and treatment decision-making for Pca experience a decline in HRQoL. Choosing treatment with a curative intent was associated with greater decline in HRQoL. Interventions aimed at optimism and decision self-efficacy could be helpful to reduce HRQoL impairment around the time of prostate biopsy and treatment decision-making.

Purpose: To determine the effect of a decision aid (DA) on treatment preferences and to investigate which patient preferences are important for final treatment preferences. We also determined if the patient׳s treatment decision was influenced by the urologist׳s treatment preference., Patients and Methods: Between August 2014 and July 2015, newly diagnosed patients with low-/intermediate-risk prostate cancer were offered to use a web-based DA after diagnosis. Treatment preferences and patient׳s values were extracted from the DA. Urologists׳ treatment preferences were indicated at the time of inclusion., Results: We included 181 patients, of whom 21% preferred active surveillance, 33% radical prostatectomy, 10% brachytherapy, 3% external beam radiotherapy, and 34% did not indicate a specific preferred treatment option after DA use (missing N = 6). Among 67%, treatment preference before DA use did not change after DA use. In men who chose active surveillance after DA use, 97% (37/38) preferred to postpone unnecessary treatment. For radical prostatectomy, 91% (52/57) of the patients valued tumor removal, and for brachytherapy, 88% (15/17) valued incontinence worse than bowel complaints. For 64% (missing N = 21) of the patients, urologists indicated one specific preferred treatment option as most suitable for the patient concerned. Agreement between final treatment decision and urologist׳s preference was lower (κ = 0.68) than between final treatment decision and preferred treatment after DA use (κ = 0.82)., Conclusion: Most patients with prostate cancer chose the treatment in accordance with the post-DA preference and to a lesser extent the urologists preference; implications of this are prospectively investigated in an ongoing study., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The best practice for the organization of follow-up care in oncology is under debate, due to growing numbers of cancer survivors. Understanding survivors' preferences for follow-up care is elementary for designing patient-centred care. Based on data from prostate cancer and melanoma survivors, this study aims to identify: 1) preferences for follow-up care providers, for instance the medical specialist, the oncology nurse or the general practitioner; 2) characteristics associated with these preferences and 3) the preferred care provider to discuss cancer-related problems., Material and Methods: Survivors diagnosed with prostate cancer (N = 535) and melanoma (N = 232) between 2007 and 2013 as registered in The Netherlands Cancer Registry returned a questionnaire (response rate was 71% and 69%, respectively). A latent class cluster model analysis was used to define preferences and a multinomial logistic regression analysis was used to identify survivor-related characteristics associated with these preferences., Results: Of all survivors, 29% reported no preference, 40% reported a preference for the medical specialist, 20% reported a preference for both the medical specialist and the general practitioner and 11% reported a preference for both the medical specialist and the oncology nurse. Survivors who were older, lower/intermediate educated and women were more likely to have a preference for the medical specialist. Lower educated survivors were less likely to have a preference for both the medical specialist and the general practitioner. Overall, survivors prefer to discuss diet, physical fitness and fatigue with the general practitioner, and hereditary and recurrence with the medical specialist. Only a small minority favored to discuss cancer-related problems with the oncology nurse., Conclusion: Survivors reported different preferences for follow-up care providers based on age, education level, gender and satisfaction with the general practitioner, showing a need for tailored follow-up care in oncology. The results indicate an urgency to educate patients about transitions in follow-up care.

Objective: To investigate decision-making role preferences and their association with the evaluation of information received in a sample of low-risk and intermediate-risk prostate cancer (Pca) survivors., Methods: Cross-sectional study involved 562 men diagnosed with low-risk or intermediate-risk Pca (median time since diagnosis, 48mo), measuring preferred decision-making role (Control Preference Scale) and the evaluation of information received (EORTC QLQ-INFO25). Analyses were performed using analysis of variance, chi-square tests, and multivariable linear regression models., Results: Men who preferred a passive role were older and less educated than other preference groups and more often selected a noninvasive treatment option (all with P<0.001). The passive role preference group reported having received less information, judged the received information as less helpful, and indicated lower overall satisfaction with information received (all with P<0.05). Role preference groups did not differ in their desire to receive more information., Conclusion: Compared with nonpassive preference groups, the preference for a passive role in Pca treatment decision-making is associated with less satisfaction with the information received., Practice Implications: Assessment of role preferences and tailored information provision could improve satisfaction with information received and perhaps may ultimately lead to improved patient participation in treatment decision-making., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: To reduce overdiagnosis and overtreatment, a test is urgently needed to detect clinically significant prostate cancer (PCa)., Objective: To develop a multimodal model, incorporating previously identified messenger RNA (mRNA) biomarkers and traditional risk factors that could be used to identify patients with high-grade PCa (Gleason score ≥7) on prostate biopsy., Design, Setting, and Participants: In two prospective multicenter studies, urine was collected for mRNA profiling after digital rectal examination (DRE) and prior to prostate biopsy. The multimodal risk score was developed on a first cohort (n=519) and subsequently validated clinically in an independent cohort (n=386)., Outcome Measurements and Statistical Analysis: The mRNA levels were measured using reverse transcription quantitative polymerase chain reaction. Logistic regression was used to model patient risk and combine risk factors. Models were compared using the area under the curve (AUC) of the receiver operating characteristic, and clinical utility was evaluated with a decision curve analysis (DCA)., Results and Limitations: HOXC6 and DLX1 mRNA levels were shown to be good predictors for the detection of high-grade PCa. The multimodal approach reached an overall AUC of 0.90 (95% confidence interval [CI], 0.85-0.95) in the validation cohort (AUC 0.86 in the training cohort), with the mRNA signature, prostate-specific antigen (PSA) density, and previous cancer-negative prostate biopsies as the strongest, most significant components, in addition to nonsignificant model contributions of PSA, age, and family history. For another model, which included DRE as an additional risk factor, an AUC of 0.86 (95% CI, 0.80-0.92) was obtained (AUC 0.90 in the training cohort). Both models were successfully validated, with no significant change in AUC in the validation cohort, and DCA indicated a strong net benefit and the best reduction in unnecessary biopsies compared with other clinical decision-making tools, such as the Prostate Cancer Prevention Trial risk calculator and the PCA3 assay., Conclusions: The risk score based on the mRNA liquid biopsy assay combined with traditional clinical risk factors identified men at risk of harboring high-grade PCa and resulted in a better patient risk stratification compared with current methods in clinical practice. Therefore, the risk score could reduce the number of unnecessary prostate biopsies., Patient Summary: This study evaluated a novel urine-based assay that could be used as a noninvasive diagnostic aid for high-grade prostate cancer (PCa). When results of this assay are combined with traditional clinical risk factors, risk stratification for high-grade PCa and biopsy decision making are improved., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To develop a web-based decision aid (DA) for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH)., Methods: From February-September 2014 we performed a four-stage development method: 1: Two-round Delphi consensus method among urologists, 2: Identifying patients' needs and expectations, 3: Development of DA content and structure, 4: Usability testing with LUTS/BPH patients., Results: 1 (N=15): Dutch urologists reached consensus on 61% of the statements concerning users' criteria, decision options, structure, and medical content. 2 (N=24): Consensus was reached in 69% on statements concerning the need for improvement of information provision, the need for DA development and that the DA should clarify patients' preferences. 3: DA development based on results from stage 1 and stage 2. 4 (N=10): Pros of the DA were clear information provision, systematic design and easy to read and re-read., Conclusion: A LUTS/BPH DA containing VCEs(**) was developed in cooperation with urologists and patients following a structured 4 stage method and was stated to be well accepted., Practice Implications: This method can be adopted for the development of DAs to support other medical decision issues., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objective: To determine the satisfaction with information received by prostate cancer survivors and associations with health-related quality of life (HRQoL) and illness perception., Methods: A cross-sectional study was performed among 999 patients diagnosed between 2006 and 2009. All patients received a questionnaire on HRQoL (EORTC QLQ-C30), illness perception (B-IPQ) and satisfaction with information provision (EORTC QLQ-INFO-25). Multivariate regression analyses were performed to assess the association between satisfaction with information provision and HRQoL as well as illness perception., Results: Response rate was 70% (N = 697), 34% (N = 222) indicated to be dissatisfied with the information received. Multivariate linear regression analyses showed a significant positive association between satisfaction with information provision and global health (P = <0.001), emotional functioning (P = 0.004), social functioning (P = 0.027), physical functioning (P = 0.002) and role functioning (P = 0.001). Satisfaction was negatively associated with illness perception subscales on consequences (P = 0.020), timeline (P = 0.031), personal control (P = 0.013), treatment control (P < 0.001), illness concern (P < 0.001), coherence (P = 0.001) and emotional representation (P = 0.004). Hence, more satisfied patients reported fewer consequences of disease, illness concern and emotional representation, but higher personal and treatment control and coherence., Conclusions: A third of all prostate cancer survivors reported to be dissatisfied with the information received and scored worse on HRQoL and illness perception. A prospective randomized study is needed to study the effect of an intervention that improves information provision on HRQoL and illness perception outcomes. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

Purpose: Serum PSA (sPSA) testing has led to the identification of patients with indolent prostate cancer, and inevitably overtreatment has become a concern. Progensa PCA3 urine testing was shown to improve the diagnosis of prostate cancer, but its diagnostic value for aggressive prostate cancer is limited. Therefore, urinary biomarkers that can be used for prediction of Gleason score ≥7 prostate cancer in biopsies are urgently needed., Experimental Design: Using gene expression profiling data, 39 prostate cancer biomarkers were identified. After quantitative PCR analysis on tissue specimens and urinary sediments, eight promising biomarkers for the urinary detection of prostate cancer were selected (ONECUT2, HOXC4, HOXC6, DLX1, TDRD1, NKAIN1, MS4A8B, PPFIA2). The hypothesis that biomarker combinations improve the diagnostic value for aggressive prostate cancer was tested on 358 urinary sediments of an intention-to-treat cohort., Results: A urinary three-gene panel (HOXC6, TDRD1, and DLX1) had higher accuracy [area under the curve (AUC), 0.77; 95% confidence interval (CI), 0.71-0.83] to predict Gleason score ≥7 prostate cancer in biopsies compared with Progensa PCA3 (AUC, 0.68; 95% CI, 0.62-0.75) or sPSA (AUC, 0.72; 95% CI, 0.65-0.78). Combining the three-gene panel with sPSA further improved the predictive accuracy (AUC, 0.81; 95% CI, 0.75-0.86). The accuracy of the three-gene predictive model was maintained in subgroups with low sPSA concentrations., Conclusions: The urinary three-gene panel (HOXC6, TDRD1, and DLX1) represents a promising tool to identify patients with aggressive prostate cancer, also in those with low sPSA values. The combination of the urinary three-gene panel with sPSA bears great potential for the early diagnosis of patients with clinically significant prostate cancer., (©2015 American Association for Cancer Research.)

Background: At an early stage, prostate cancer patients are often eligible for more than one treatment option, or may choose to defer curative treatment. Without a pre-existing superior option, a patient has to weigh his personal preferences against the risks and benefits of each alternative to select the most appropriate treatment. Given this context, in prostate cancer treatment decision-making, it is particularly suitable to follow the principles of shared decision-making (SDM), especially with the support of specific instruments like decision aids (DAs). Although several alternatives are available, present tools are not sufficiently compatible with routine clinical practice. To overcome existing barriers and to stimulate structural implementation of DAs and SDM in clinical practice, a web-based prostate cancer treatment DA was developed to fit clinical workflow. Following the structure of an existing DA, Dutch content was developed, and values clarification methods (VCMs) were added. The aim of this study is to investigate the effect of this DA on (shared) treatment choice and patient-reported outcomes., Methods/design: Nineteen Dutch hospitals are included in a pragmatic, cluster randomized controlled trial, with an intervention and a control arm. In the intervention group, the DA will be offered after diagnosis, and a summary of the patients' preferences, which were identified with the DA, can be discussed by the patient and his clinician during later consultation. Patients in the control group will receive information and decisional support as usual. Results from both groups on decisional conflict, treatment choice and the experience with involvement in the decision-making process are compared. Patients are requested to fill in questionnaires after treatment decision-making but before treatment is started, and 6 and 12 months later. This will allow the development of treatment satisfaction, decisional regret, and quality of life to be monitored. Clinicians from both groups will evaluate their practice of information provision and decisional support., Discussion: This study will describe a web-based prostate cancer treatment DA with VCMs. The effect of this DA on the decision-making process and subsequent patient reported outcomes will be evaluated., Trial Registration: The Netherlands National Trial Register: NTR4554, registration date 1 May 2014.

Introduction: Additional insight in the occurrence and number of positive surgical margins (PSM) and the potential consequences is needed, since earlier studies show divergent results. This study aims at investigating the effect of the presence and number of PSM on oncological outcomes., Methods: Retrospective population-based cohort study including 648 consecutive prostate cancer patients who underwent RP in the Southern Netherlands in 2006-2008. The effect of PSM on risk of treatment failure, defined by either biochemical recurrence or necessity of any additional therapy (Cox regression), was evaluated., Results: PSM were observed in 39%; 11% had multiple PSM. Treatment failure was observed in 26% of all patients. Multivariably, the presence (hazard ratio 2.5) and number of PSM (hazard ratios: single 2.3; multiple 3.1) were independently associated with higher treatment failure rates, unlike location of PSM., Conclusions: Treatment failure rates are high among patients with PSM, especially in those with multiple PSM. This needs to be taken into account when decisions are made on the applicability of the adjuvant and salvage therapy., (© 2015 S. Karger AG, Basel.)

Objective: The aim of the study was to evaluate the effect of positive surgical margins (PSM) on health-related quality of life and illness perception after radical prostatectomy in patients with prostate cancer., Methods: Of all patients with prostate cancer diagnosed between 2006 and 2009 in 7 participating hospitals in the Eindhoven region of the Netherlands Cancer Registry, 197 patients who underwent radical prostatectomy were invited to fill in a questionnaire. Data from the Netherlands Cancer Registry were combined with questionnaire data (including European Organization for Research and Treatment of Cancer quality of life questionnaire-C30, quality of life questionnaire-Prostate Module 25, and the Brief Illness Perception Questionnaire). Mean scores per margin status group were compared in multivariate linear regression., Results: Of the addressed patients, 166 (84%) responded to the questionnaire. At time of questioning, their surgery was 1.7 to 6.4 years ago. The prevalence of PSM was 34%. On most scales, patients with PSM reported more favorable scores than patients with negative surgical margins. However, differences were mostly trivial (<5 points on 100-point scales), or of small (5-10) to medium (10-20) clinical importance. Only differences on hormonal complaints and illness comprehensibility were statistically significant. Effect of PSM on scores did not vary between patients who were at different time points after surgery., Conclusion: Although patients with PSM showed a trend toward more favorable scores, these differences were of little or no clinical importance. Additional research is needed to evaluate how patients value these differences with respect to oncological outcomes., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Our study assessed whether rising age, socioeconomic status (SES) and the presence of serious comorbidity affected treatment choice and survival in a population-based series of patients with muscle-invasive bladder cancer (MIBC) in The Netherlands. Therefore, a consecutive series was studied, including all patients diagnosed with MIBC between 1995 and 2009 in the Eindhoven Cancer Registry, preceding centralization of cystectomy. The independent effects of age, SES and serious comorbidity on therapy choice and their effects on overall survival were estimated by multivariate logistic regression and multivariate Cox proportional hazard analyses, respectively. Out of the 2,445 patients, 38% were aged ≥ 75 years at diagnosis and 63% had at least one serious comorbid condition. Higher age and serious comorbidity were independent predictors for abstaining from cystectomy, where SES was not (61-74 vs. ≤ 60: odds ratio [OR], 0.8; 95% confidence interval [CI], 0.6-1.0; ≥ 75 vs. ≤ 60: OR, 0.1; 95% CI,0.1-0.2; one comorbid condition vs. none: OR, 0.7; 95% CI, 0.5-0.9; two vs. none: OR, 0.6; 95% CI, 0.5-0.8). Patients undergoing cystectomy, external beam radiotherapy or interstitial radiotherapy survived longer independent of age, SES and serious comorbidity (hazard ratio [HR]: 0.4; 95% CI: 0.4-0.5; HR: 0.8; 95% CI: 0.7-0.9; HR: 0.4; 95% CI: 0.3-0.5, respectively). Consequently, preceding centralization of cystectomy, higher age and serious comorbidity were independent predictors for abstaining from cystectomy owing to an expected high rate of short-term medical problems. As cystectomy is associated with a better survival, independently of age, SES and serious comorbidity, it can be questioned whether cystectomy has been underutilised in elderly and in patients with serious comorbidity. Centralization might be a solution for this suggested underutilisation., (© 2014 UICC.)

Background: Prostate cancer antigen 3 (PCA3) and v-ets erythroblastosis virus E26 oncogene homolog (TMPRSS2-ERG) gene fusions are promising prostate cancer (PCa) specific biomarkers that can be measured in urine., Objective: To evaluate the diagnostic and prognostic value of Progensa PCA3 and TMPRSS2-ERG gene fusions (as individual biomarkers and as a panel) for PCa in a prospective multicentre setting., Design, Setting, and Participants: At six centres, post-digital rectal examination first-catch urine specimens prior to prostate biopsies were prospectively collected from 497 men. We assessed the predictive value of Progensa PCA3 and TMPRSS2-ERG (quantitative nucleic acid amplification assay to detect TMPRSS2-ERG messenger RNA [mRNA]) for PCa, Gleason score, clinical tumour stage, and PCa significance (individually and as a marker panel). This was compared with serum prostate-specific antigen and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator. In a subgroup (n=61) we evaluated biomarker association with prostatectomy outcome., Outcome Measurements and Statistical Analysis: Univariate and multivariate logistic regression analysis and receiver operating curves were used., Results and Limitations: Urine samples of 443 men contained sufficient mRNA for marker analysis. PCa was diagnosed in 196 of 443 men. Both PCA3 and TMPRSS2-ERG had significant additional predictive value to the ERSPC risk calculator parameters in multivariate analysis (p<0.001 and resp. p=0.002). The area under the curve (AUC) increased from 0.799 (ERSPC risk calculator), to 0.833 (ERSPC risk calculator plus PCA3), to 0.842 (ERSPC risk calculator plus PCA3 plus TMPRSS2-ERG) to predict PCa. Sensitivity of PCA3 increased from 68% to 76% when combined with TMPRSS2-ERG. TMPRSS2-ERG added significant predictive value to the ERSPC risk calculator to predict biopsy Gleason score (p<0.001) and clinical tumour stage (p=0.023), whereas PCA3 did not., Conclusions: TMPRSS2-ERG had independent additional predictive value to PCA3 and the ERSPC risk calculator parameters for predicting PCa. TMPRSS2-ERG had prognostic value, whereas PCA3 did not. Implementing the novel urinary biomarker panel PCA3 and TMPRSS2-ERG into clinical practice would lead to a considerable reduction of the number of prostate biopsies., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: The purpose of this study was to measure patient-reported outcomes (PROs) for patients with muscle-invasive bladder cancer (BC) before the diagnosis of BC was known, thus before cystectomy, and until 1 year postcystectomy. The differences in outcomes between a health status (HS) and quality of life (QoL) questionnaires were examined., Methods: From July 2007 to July 2010, 598 patients with primary hematuria were enrolled in this prospective, multi-centre case-control (CC) study. Patients undergoing radical cystectomy (RC; N = 18) were compared with patients with other causes of hematuria (CC, N = 20). Measurement points were before diagnosis as well as 3, 6 and 12 months postcystectomy. Questionnaires used were the WHOQOL-BREF, SF-12, International Index of Erectile Function, and 10-item STAI-Trait scale., Results: Prediagnosis patients who later appeared to have BC had the same QoL compared to CC patients. The prediagnosis physical component scale of HS and sexual function were significantly lower for RC vs. CC patients. RC patients had a better prediagnostic QoL and HS than postcystectomy at all time points., Conclusions: This is the first case-control study with a baseline measurement of PROs before the diagnosis of BC was known. It shows lower physical health and sexual function for RC vs. CC before diagnosis is known. Until 1 year postcystectomy, QoL does not return to baseline level. Future studies including comorbidity and smoking history are needed to examine the generalizability of our results.

Purpose: To examine quality of life (QoL), health status, sexual function, and anxiety in patients with primary hematuria who later appear to have bladder cancer (BC) and patients with other diagnoses., Methods: From July 2007 to July 2010, 598 patients with primary hematuria were enrolled in this prospective, multicenter study. Questionnaires (WHOQOL-BREF, SF-12, IIEF, STAI-10-item Trait) were completed before cystoscopy. Diagnosis was subsequently derived from medical files. BC patients were compared with patients with other causes of hematuria., Results: Cancer was diagnosed in 131 patients (21.9 %), including 102 patients (17.1 %) with BC. No differences were found in the WHOQOL-BREF versus SF-12 psychological or physical health domains. The erectile function was significantly worse in the BC group (9.3 vs. 14.6 for OC, p = 0.02). Patients with muscle-invasive BC (MIBC) had the lowest percentage anxious personalities of all BC patients (p = 0.04)., Conclusions: Cancer was found in 21.9 % of the patients with hematuria. Pre-diagnosis patients with BC have comparable QoL and HS to patients with OC. Erectile dysfunction was highest in patients with BC. MIBC patients had the lowest percentage anxious personalities of the patients with BC.

Background: Prediction models need validation to assess their value outside the development setting., Objective: To assess the external validity of the European Randomised study of Screening for Prostate Cancer (ERSPC) Risk Calculator (RC) in a contemporary clinical cohort., Methods: The RC calculates the probability of a positive sextant prostate biopsy (P(posb)) using serum prostate-specific antigen (PSA), results of digital rectal examination, transrectal ultrasound (TRUS) and ultrasound assessed prostate volume. We prospectively validated the RC in 320 biopsied men (55-75 years), with no previous prostate biopsy, included in five Dutch hospitals in 2008-2011. If the P(posb) was ≥ 20% a biopsy was recommended. The performance of the RC was tested by comparing the observed outcomes to predicted probabilities, using the area under the curve (AUC) and decision curves analyses., Results: Compared to the screening cohort, men in the clinical cohort differed. They had higher PSA levels (median 6.8 versus 4.3 ng/ml, p<0.01), less TRUS-lesions (27% versus 34%, p = 0.01) and more prostate cancer (PCa) at biopsy (43% versus 25%, p<0.01). Mainly eight biopsy cores were taken. Despite the differences between these cohorts, the mean observed probability agreed with the mean predicted probability (43% versus 40%). The RC predicted P(posb) better than a model with PSA and digital rectal examination, AUC 0.77 (95% confidence interval (CI) 0.72-0.83) and 0.71 (95%CI 0.65-0.76, p<0.01), respectively. This was confirmed by the decision curves analysis. Under the 20% threshold, 17% (11/63) of the biopsied men were diagnosed with PCa. Two of 11 men had an important cancer (Gleason 3+4)., Conclusions: The ERSPC RC performs well in a Dutch clinical cohort in men with previous PSA tests and contemporary biopsy schemes, and outperforms a PSA and DRE-based approach in the decision to perform a biopsy., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Unlabelled: Study Type - Prognosis (cohort series). Level of Evidence 2a. What's known on the subject? and What does the study add? The present study is one of the first to investigate urologists' and patients' compliance with recommendations based on a risk calculator that calculates the probability of indolent prostate cancer. A threshold was set for a recommendation of active surveillance vs active treatment. Active surveillance recommendations based on a prostate cancer risk calculator were followed by most patients, but 30% with active treatment recommendations chose active surveillance instead. This indicates that the threshold may be too high for urologists and patients., Objectives: • To assess urologists' and patients' compliance with treatment recommendations based on a prostate cancer risk calculator (RC) and the reasons for non-compliance. • To assess the difference between patients who were compliant and non-compliant with recommendations based on this RC., Patients and Methods: • Eight urologists from five Dutch hospitals included 240 patients with prostate cancer (PCa), aged 55-75 years, from December 2008 to February 2011. • The urologists used the European Randomized Study of Screening for Prostate Cancer RC which predicts the probability of potentially indolent PCa (P[indolent]), using serum prostate-specific antigen (PSA), prostate volume and pathological findings on biopsy. • Inclusion criteria were PSA <20 ng/mL, clinical stage T1 or T2a-c disease, <50% positive sextant biopsy cores, ≤ 20 mm cancer tissue, ≥ 40 mm benign tissue and Gleason ≤ 3 + 3. If the P(indolent) was >70%, active surveillance (AS) was recommended, and active treatment (AT) otherwise. • After the treatment decision, patients completed a questionnaire about their treatment choice, related (dis)advantages, and validated measurements of other factors, e.g. anxiety., Results: • Most patients (45/55, 82%) were compliant with an AS recommendation. Another 54 chose AS despite an AT recommendation (54/185, 29%). • The most common reason for non-compliance with AT recommendations by urologists was the patient's preference for AS (n= 30). These patients most often reported the delay of physical side effects of AT as the main advantage (n= 19). • Those who complied with AT recommendations had higher mean PSA levels (8 vs 7 ng/mL, P= 0.02), higher mean amount of cancer tissue (7 vs 3 mm, P < 0.001), lower mean P(indolent) (36% vs 55%, P < 0.001), and higher mean generic anxiety scores (42 vs 38, P= 0.03) than those who did not comply., Conclusions: • AS recommendations were followed by most patients, while 29% with AT recommendations chose AS instead. • Although further research is needed to validate the RC threshold, the current version is already useful in treatment decision-making in men with localized PCa., (© 2011 BJU INTERNATIONAL.)

Unlabelled: Study Type - Prognosis (cohort). Level of Evidence 2a. What's known on the subject? and What does the study add? The subject of mortality and survival rates after radical cystectomies in high-volume hospitals in comparison to low-volume hospitals has been extensively studied. Postoperative mortality is known to be significantly lower with high-volume providers, but for survival rates there was only a trend forwards this finding. For this reason, we performed this Dutch population-based study on survival rates, to see if we had enough power to support this trend with significant findings. To our knowledge, this is the first study of good quality showing a significant beneficial effect for survival in high-volume hospitals., Objective: • To examine the volume-outcome relationship for carcinoma invading bladder muscle (MIBC) with respect to differences in survival rates among all hospitals in the Netherlands as a guide for regionalization initiatives., Materials and Methods: • This population-based retrospective study included all patients (n= 13 033) newly diagnosed with MIBC during the period 1999-2008 in the Netherlands, selected from the Netherlands Cancer Registry. • Data were collected on demographics, morphology, stage at diagnosis and after surgery, primary treatment, vital status and date of follow-up or death. • The relative survival rate (RSR) per treatment was analysed for age, stage and hospital surgical volume., Results: • Overall 5 and 10-year RSR for all treatments of MIBC was 32% and 25%, respectively. • Although 71.7% of the patients featured stages II and III, radical cystectomy was only performed in only 42% and 44% of these patients, respectively. • Relative survival for MIBC remained unchanged in the two consecutive time periods (1999-2003 and 2004-2008). • In all, 34% of patients diagnosed in low-volume hospitals (<10 cystectomies/year) underwent cystectomy vs 42% of those diagnosed in high-volume hospitals (P= 0.000). • In a multivariate analysis long-term survival (>30 days after surgery) was significantly lower in patients after cystectomy for stage II/III in low-volume hospitals (hazard ratio [HR] 1.17, P= 0.036). A high lymph node count (>20) was associated with a lower risk of death (HR 0.52, P= 0.000)., Conclusions: • The 10-year RSR for patients with MIBC in the Netherlands was modest (25%) and has remained unchanged in the last decade. • The chance of undergoing cystectomy is significantly higher in high-volume hospitals. Long-term survival after cystectomy is higher in high-volume hospitals. • Regionalization of bladder cancer treatments could improve overall outcomes., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

A family history of prostate cancer (PCa) is an established risk factor for PCa. In case of a positive family history, the balance between positive and adverse effects of prostate-specific antigen (PSA) testing might be different from the general population, for which the European Randomized Study of Screening for Prostate Cancer (ERSPC) showed a beneficial effect on mortality. This, however, went at the cost of considerable overtreatment. This study assessed Dutch physicians' knowledge of heredity and PCa and their 'post-ERSPC' attitude towards PCa testing, including consideration of family history. In January 2010, all Dutch urologists and clinical geneticists (CGs) and 300 general practitioners (GPs) were invited by email to complete an anonymous online survey, which contained questions about hereditary PCa and their attitudes towards PCa case-finding and screening. 109 urologists (31%), 69 GPs (23%) and 46 CGs (31%) completed the survey. CGs had the most accurate knowledge of hereditary PCa. All but 1 CG mentioned at least one inherited trait with PCa, compared to only 25% of urologists and 9% of GPs. CGs hardly ever counseled men about PCa testing. Most urologists and GPs discuss possible risks and benefits before testing for PCa with PSA. Remarkably, 35-40% of them do not take family history into consideration. Knowledge of urologists and GPs about heredity and PCa is suboptimal. Hence, PCa counseling might not be optimal for men with a positive family history. Multidisciplinary guidelines on this topic should be developed to optimize personalized counseling.

Unlabelled: Study Type - Diagnostic (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? So far, few publications have shown that a prediction model influences the behaviour of both physicians and patients. To our knowledge, it was unknown whether urologists and patients are compliant with the recommendations of a prostate cancer risk calculator and their reasons for non-compliance. Recommendations of the European Randomized study of Screening for Prostate Cancer risk calculator (ERSPC RC) about the need of a prostate biopsy were followed in most patients. In most cases of non-compliance with 'no biopsy' recommendations, a PSA level ≥ 3 ng/mL was decisive to opt for biopsy. Before implementation of the ERSPC RC in urological practices at a large scale, it is important to obtain insight into the use of guidelines that might counteract the adoption of the use of the RC as a result of opposing recommendations., Objectives: To assess both urologist and patient compliance with a 'no biopsy' or 'biopsy' recommendation of the European Randomized study of Screening for Prostate Cancer (ERSPC) Risk Calculator (RC), as well as their reasons for non-compliance. To assess determinants of patient compliance., Patients and Methods: The ERSPC RC calculates the probability on a positive sextant prostate biopsy (P(posb) ) using serum prostate-specific antigen (PSA) level, outcomes of digital rectal examination and transrectal ultrasonography, and ultrasonographically assessed prostate volume. A biopsy was recommended if P(posb) ≥20%. Between 2008 and 2011, eight urologists from five Dutch hospitals included 443 patients (aged 55-75 years) after a PSA test with no previous biopsy. Urologists calculated the P(posb) using the RC in the presence of patients and completed a questionnaire about compliance. Patients completed a questionnaire about prostate cancer knowledge, attitude towards prostate biopsy, self-rated health (12-Item Short Form Health Survey), anxiety (State Trait Anxiety Inventory-6, Memorial Anxiety Scale for Prostate Cancer) and decision-making measures (Decisional Conflict Scale)., Results: Both urologists and patients complied with the RC recommendation in 368 of 443 (83%) cases. If a biopsy was recommended, almost all patients (96%; 257/269) complied, although 63 of the 174 (36%) patients were biopsied against the recommendation of the RC. Compliers with a 'no biopsy' recommendation had a lower mean P(posb) than non-compliers (9% vs 14%; P < 0.001). Urologists opted for biopsies against the recommendations of the RC because of an elevated PSA level (≥ 3 ng/mL) (78%; 49/63) and patients because they wanted certainty (60%; 38/63)., Conclusions: Recommendations of the ERSPC RC on prostate biopsy were followed in most patients. The RC hence may be a promising tool for supporting clinical decision-making., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

Purpose: The Prostate CAncer gene 3 (PCA3) assay may guide prostate biopsy decisions and predict prostate cancer (PCa) aggressiveness. This study explored the appropriateness of (1) PCA3 testing; (2) biopsy; (3) active surveillance (AS) and the value of the PCA3 Score for biopsy and AS decisions., Methods: Using the RAND/UCLA appropriateness method, 12 urologists assessed the appropriateness of PCA3, biopsy and AS for theoretical patient profiles, constructed by combining clinical variables. They individually scored the appropriateness for all profiles using a 9-point scale. Based on the median score and extent of agreement, the appropriateness for each profile was calculated., Results: The PCA3 Assay was mainly considered appropriate in men with ≥1 negative biopsy, PSA ≥ 3 ng/mL and life expectancy (LE) ≥10 years. A LE < 10 years, ≥2 negative biopsies and PCA3 Score <20 decreased biopsy appropriateness, while PSA ≥ 3 ng/mL and PCA3 Score >50 increased it. In men without a prior biopsy, LE ≥ 10 years and a suspicious DRE, PCA3 did not affect biopsy appropriateness. In other men, a PCA3 Score <20 discouraged biopsy, while a value ≥35 supported biopsy. AS was mainly considered appropriate if LE < 10 years, T1c PCa, ≤20% positive cores and PSA < 3 ng/mL. A PCA3 Score <20 pleads for and higher scores (particularly >50) against AS., Conclusions: These findings illustrate in which men PCA3 can be of additional value when taking biopsy and treatment decisions in clinical practice.

Purpose: We evaluated the clinical utility of the PCA3 assay in guiding initial biopsy decisions in prostate cancer., Materials and Methods: A European, prospective, multicenter study enrolled men with a serum total prostate specific antigen of 2.5 to 10 ng/ml scheduled for initial biopsy. After digital rectal examination first catch urine was collected. PCA3 scores were determined using the PROGENSA(®) PCA3 assay and compared to biopsy outcome. The diagnostic accuracy of PCA3 was compared to total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen., Results: In 516 men the positive biopsy rate was 40%. An increasing PCA3 score corresponded with an increasing probability of a positive biopsy. The mean PCA3 score was higher in men with a positive vs a negative biopsy (69.6 vs 31.0, median 50 vs 18, p <0.0001). The PCA3 score was independent of age, total prostate specific antigen and prostate volume. The PCA3 score (cutoff of 35) had a sensitivity of 64% and specificity of 76%. ROC analysis showed a significantly higher AUC for the PCA3 score vs total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen. The PCA3 score was significantly higher in men with biopsy Gleason score 7 or greater vs less than 7, greater than 33% vs 33% or fewer positive cores and significant vs indolent prostate cancer. Inclusion of PCA3 in multivariable models increased their predictive accuracy by up to 5.5%., Conclusions: The PROGENSA PCA3 assay can aid in guiding biopsy decisions. It is superior to total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen in predicting initial biopsy outcome, and may be indicative of prostate cancer aggressiveness., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Context: There is an ongoing debate about centralisation of radical cystectomy (RC) procedures., Objective: To conduct a systematic review of the literature on the volume-outcome relationship for RC for bladder cancer (BCa) with consideration for the methodologic quality of the available evidence and to perform a meta-analysis on the studies meeting predefined quality criteria., Evidence Acquisition: A systematic search was performed to identify all articles examining the effects of procedure volume on clinical outcome for cystectomy. Reviews, opinion articles, and surveys were excluded. All articles were critically appraised for methodologic quality and risk of bias. Meta-analysis was performed to calculate the overall effect of higher surgeon or hospital volume on patient outcome., Evidence Synthesis: Ten studies of good methodologic quality were included for meta-analysis. Eight studies were based on administrative data, two studies on clinical data. The results showed a significant association between high-volume hospitals and low mortality. A meta-analysis of the seven studies on hospital mortality showed a pooled estimated effect of odds ratio (OR) 0.55 (range: 0.44-0.69). The result was moderate heterogeneity (I(2)=50). A large variation in cut-off points used was observed. Sensitivity analyses did not show different effects in any of the subgroup analyses. Also, no significant differences in effect sizes were observed for different cut-off points. The data were not suggestive for publication bias. One study showed a positive effect of hospital volume on survival (hazard ratio [HR]: 0.89; p=0.06). Two studies showed a beneficial effect of surgeon volume on mortality (OR: 0.55; OR: 0.64). Only one study on the impact of surgeon volume on survival was found; it showed no significant positive effect for higher volume (HR: 0.83; p=0.26)., Conclusions: Postoperative mortality after cystectomy is significantly inversely associated with high-volume providers. However, additional quality criteria, such as infrastructure and level of specialisation, should be formulated to direct centralisation initiatives. The Dutch Association of Urology in 2010 implemented a national quality of care (QoC) registration programme for all patients treated by surgery for muscle-invasive BCa, including multiple parameters defining QoC., (Crown Copyright © 2011. Published by Elsevier B.V. All rights reserved.)

Objective: To define a set of quantifiable quality of care indicators (QIs) to measure the standard of care in our institute given to patients with muscle-invasive bladder cancer (MIBC)., Patients and Methods: Possible QIs were defined and selected by a multidisciplinary project group from recent literature, guidelines, and/or consensus within the project group. In a retrospective study a baseline for each QI was assessed and compared to a predefined benchmark., Results: Four categories of QIs were selected: (1) care management, (2) accessibility and time management, (3) professional competence, and (4) patient factors. A list of 26 QIs was created. In the retrospective study, it became evident that 22 QIs failed to reach their benchmark, because of (1) an inadequate process of care (n = 5), (2) insufficient care given (n = 14), and (3) data not retrievable in retrospective study design (n = 2). Adjustments were made in the different processes of care in order to improve quality of care., Conclusions: In the face of a complete lack of a QoC registration system for MIBC, we listed 26 quantifiable QIs, to measure QoC in our own institute. Our process of care did not meet 22 of the benchmarks, after which adjustments were made. This QoC registration method is a first step in defining applicable quality of care indicators, for implementation in the clinical practice., (Copyright © 2010 S. Karger AG, Basel.)

Background: Prior to safely adopting risk stratification tools, their performance must be tested in an external patient cohort., Objective: To assess accuracy and generalizability of previously reported, internally validated, prebiopsy prostate cancer antigen 3 (PCA3) gene-based nomograms when applied to a large, external, European cohort of men at risk of prostate cancer (PCa)., Design, Setting, and Participants: Biopsy data, including urinary PCA3 score, were available for 621 men at risk of PCa who were participating in a European multi-institutional study., Intervention: All patients underwent a ≥10-core prostate biopsy. Biopsy indication was based on suspicious digital rectal examination, persistently elevated prostate-specific antigen level (2.5-10 ng/ml) and/or suspicious histology (atypical small acinar proliferation of the prostate, >/= two cores affected by high-grade prostatic intraepithelial neoplasia in first set of biopsies)., Measurements: PCA3 scores were assessed using the Progensa assay (Gen-Probe Inc, San Diego, CA, USA). According to the previously reported nomograms, different PCA3 score codings were used. The probability of a positive biopsy was calculated using previously published logistic regression coefficients. Predicted outcomes were compared to the actual biopsy results. Accuracy was calculated using the area under the curve as a measure of discrimination; calibration was explored graphically., Results and Limitations: Biopsy-confirmed PCa was detected in 255 (41.1%) men. Median PCA3 score of biopsy-negative versus biopsy-positive men was 20 versus 48 in the total cohort, 17 versus 47 at initial biopsy, and 37 versus 53 at repeat biopsy (all p≤0.002). External validation of all four previously reported PCA3-based nomograms demonstrated equally high accuracy (0.73-0.75) and excellent calibration. The main limitations of the study reside in its early detection setting, referral scenario, and participation of only tertiary-care centers., Conclusions: In accordance with the original publication, previously developed PCA3-based nomograms achieved high accuracy and sufficient calibration. These novel nomograms represent robust tools and are thus generalizable to European men at risk of harboring PCa. Consequently, in presence of a PCA3 score, these nomograms may be safely used to assist clinicians when prostate biopsy is contemplated., (Copyright © 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To assess and identify factors associated with the long-term health-related quality of life (HRQL) of prostate cancer survivors managed expectantly, as patients with low-risk prostate cancer can be managed with active surveillance (AS), but research on associated long-term HRQL is scarce., Patients and Methods: From the population-based Eindhoven Cancer Registry, 71 men managed with AS were matched with 71 survivors who had similar demographic and clinical characteristics but treated with external beam radiotherapy (RT). All were diagnosed between 1994 and 1998. HRQL data were collected 5-10 years after diagnosis. Patients completed generic- (Short Form-36) and cancer-specific (Quality of Life - Cancer Survivors) HRQL instruments, and symptom burden (Expanded Prostate Cancer Index, Sexual Activity) questionnaires., Results: Patients on AS were comparable to those treated with RT for most generic- and disease-specific HRQL dimensions. Patients treated with RT had poorer mean (sd) bowel function scores, of 87.1 (13.1) vs 92.8 (10.7) (P < 0.001), more bother with bowel function, at 85.0 (16.4) vs 93.7 (10.1) (P < 0.001), and more problems with getting an erection (68% vs 47%, P = 0.005). Multivariate regression analyses (corrected for comorbidity and clinical disease progression) indicated that the management strategy independently predicted differences in physical functioning, bodily pain, spiritual and total well-being, and bowel function and bowel bother., Conclusions: Patients managed expectantly at initial diagnosis (AS) have comparable HRQL and a lower symptom burden than patients treated with RT up to 10 years after the diagnosis.

Background: The combination of radiotherapy plus long-term medical suppression of androgens (> or = 2 years) improves overall survival in patients with locally advanced prostate cancer. We compared the use of radiotherapy plus short-term androgen suppression with the use of radiotherapy plus long-term androgen suppression in the treatment of locally advanced prostate cancer., Methods: We randomly assigned patients with locally advanced prostate cancer who had received external-beam radiotherapy plus 6 months of androgen suppression to two groups, one to receive no further treatment (short-term suppression) and the other to receive 2.5 years of further treatment with a luteinizing hormone-releasing hormone agonist (long-term suppression). An outcome of noninferiority of short-term androgen suppression as compared with long-term suppression required a hazard ratio of more than 1.35 for overall survival, with a one-sided alpha level of 0.05. An interim analysis showed futility, and the results are presented with an adjusted one-sided alpha level of 0.0429., Results: A total of 1113 men were registered, of whom 970 were randomly assigned, 483 to short-term suppression and 487 to long-term suppression. After a median follow-up of 6.4 years, 132 patients in the short-term group and 98 in the long-term group had died; the number of deaths due to prostate cancer was 47 in the short-term group and 29 in the long-term group. The 5-year overall mortality for short-term and long-term suppression was 19.0% and 15.2%, respectively; the observed hazard ratio was 1.42 (upper 95.71% confidence limit, 1.79; P=0.65 for noninferiority). Adverse events in both groups included fatigue, diminished sexual function, and hot flushes., Conclusions: The combination of radiotherapy plus 6 months of androgen suppression provides inferior survival as compared with radiotherapy plus 3 years of androgen suppression in the treatment of locally advanced prostate cancer. (ClinicalTrials.gov number, NCT00003026.), (2009 Massachusetts Medical Society)

Objective: The aim of this study was to evaluate the value of urodynamic investigation in the preoperative workup of midurethral sling surgery and to identify risk factors for failure after 3 different midurethral sling procedures., Study Design: Retrospective cohort study. 437 women who underwent a tension-free vaginal tape, Monarc, or tension-free vaginal tape-obturator procedure without other simultaneously performed urogynecological surgery were included. Preoperative data were collected from the medical files. Patients who reported any amount of leakage were considered failures. The mean follow-up of the study population was 14 months., Results: After multivariate analysis, mixed urinary incontinence (P = .04), previous incontinence surgery (P = .022), and detrusor overactivity (P = .02) were significantly related to failure of midurethral sling procedures. There were no predictive urodynamic parameters for failure in patients with mixed urinary incontinence or previous incontinence surgery., Conclusion: The standard use of urodynamic investigation in the preoperative workup of midurethral sling surgery needs to be revisited.

Purpose: To obtain insight into the long-term (5- to 10-year) effects of prostate cancer and treatment on bowel, urinary, and sexual function, we performed a population-based study. Prostate-specific function was compared with an age-matched normative population without prostate cancer., Methods and Materials: Through the population-based Eindhoven Cancer Registry, we selected all men diagnosed with prostate cancer between 1994 and 1998 in the southern Netherlands. In total, 964 patients, alive in November 2004, received questionnaire; 780 (81%) responded., Results: Urinary problems were most common after a prostatectomy; bowel problems were most common after radiotherapy. Compared with an age-matched normative population both urinary and bowel functioning and bother were significantly worse among survivors. Urinary incontinence was reported by 23-48% of survivors compared with 4% of the normative population. Bowel leakage occurred in 5-14% of patients compared with 2% of norms. Erection problems occurred in 40-74% of patients compared with 18% of norms., Conclusions: These results form an important contribution to the limited information available on prostate-specific problems in the growing group of long-term prostate cancer survivors. Bowel, urinary, and sexual problems occur more often among long-term survivors compared with a reference group and cannot be explained merely by age. Because these problems persist for many years, urologists should provide patients with adequate information before treatment. After treatment, there should be an appropriate focus on these problems.

Objective: To assess the health-related quality of life (HRQoL) of long-term, disease-free prostate cancer survivors and compare it with that of prostate cancer survivors with diabetes mellitus (DM), and a Dutch normative population, as comorbidity can have a major impact on HRQoL in cancer survivors., Patients and Methods: The Eindhoven Cancer Registry was used to select all men diagnosed with prostate cancer from 1994 to 1998. Questionnaires on HRQoL (Short Form 36) and prostate specific problems (University of California, Los Angeles Expanded Prostate Cancer Index) were sent to 964 patients, and 780 (81%) responded. Excluding patients with disease progression, the sample comprised 525 with prostate cancer and 65 with both prostate cancer and DM. Survivors with DM were more likely to have other comorbid conditions at the time of survey besides DM than were those without DM (74% vs 60%, P = 0.05). At 5-10 years after diagnosis, patients with DM reported worse General Health Perceptions than patients without DM or the normative population (means 52, 61 and 63; P < 0.001). Patients with DM also reported worse Vitality scores (59 vs 63; P < 0.001) than the normative population. Regression analysis indicated that DM was negatively associated with General Health Perceptions (beta = -0.13; P < 0.01) and Vitality (beta = -0.12; P < 0.01). Survivors with DM did not report worse urinary and bowel function or bother, nor more sexual problems than those without DM., Conclusions: Except for general health perceptions and vitality, the HRQoL of prostate cancer survivors with or without DM was comparable to a normative population. Survivorship selection can possibly explain, in part, why patients with DM did not report worse generic or disease-specific HRQoL than those without DM, as had been expected.

It is common belief that in families with hereditary prostate cancer (HPC), unaffected men should be screened periodically with PSA, but little is known about the effects of such screening. We studied test and tumor characteristics in unaffected 50-75-year-old screenees from HPC families. In the Netherlands, 153 verified HPC families are registered; 132 unaffected men in these families were not under surveillance for prostate cancer and gave informed consent for PSA testing by their GP and referral to a urologist in the case of a PSA level >or= 3.0 ng/ml. Results were compared to published data from the Rotterdam and Göteborg sections of the European Randomized Study of Screening for Prostate Cancer (ERSPC). A PSA >or= 3.0 ng/ml was found in 20 men: referral rate, 15.1% (ERSPC Rotterdam: 20.1%; ERSPC Göteborg: 12.0%). Only 3 cases of prostate cancer were diagnosed in these men: detection rate in the first screening round 2.3% (ERSPC Rotterdam: 5.3%; ERSPC Göteborg: 2.3%). Frequent opportunistic PSA testing made it impossible to estimate the detection rates in subsequent screening rounds. In the first and subsequent PSA screening rounds, 11 cases of cancer were detected. All but 1 had favorable tumor characteristics (cT1c/pT2; Gleason < 7). These results raise the question as to whether men from all HPC families should be considered at high-risk. We suggest that the same PSA testing guidelines should apply to HPC families and the general population. A more aggressive screening policy in HPC families does not seem to be justified., ((c) 2007 Wiley-Liss, Inc.)

Objectives: In preparation of an intercontinental Phase III trial comparing continuous maximal androgen blockade (MAB) to intermittent androgen suppression (IAS) in untreated metastatic prostate cancer, a feasibility study on IAS was accomplished., Methods: 107 patients (median follow-up 92 weeks) were treated with MAB until a PSA nadir was reached. Nadir was defined as PSA below 20 ng/ml corresponding to PSA reduction by at least 80% of baseline value. Criteria for restarting treatment was PSA >20 ng/ml and PSA > nadir + 50%. Trials aim was to assess the likelihood that 80% of patients would reach a first nadir and that 80% of these would also reach a second nadir., Results: 51.4% of patients had some degree of pain at entry, 27.1% had >15 hot spots, 23.7% demonstrated obstruction. Only 17.8% had normal potency, 56.1% were totally impotent. One to seven cycles of treatment were given. 76.6% of patients reached a 1st nadir after a median of 19 weeks of treatment, 84.1% of these started the 2nd cycle and 71% of them reached a 2nd nadir after a median of 13.6 weeks. Median time off-treatment was 14.3 and 16.0 weeks corresponding to 38.4% and 48.5% of the duration of each cycle. A similar proportion of patients was reported to be potent during follow-up compared to baseline. 32.7% of patients died during follow-up, 82.9% of prostate cancer., Conclusion: Around 75% of the patients achieved a nadir at each cycle. The concept of IAS seems to be feasible and warrants further investigation.