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Purpose: To compare long-term (4-10 years) quality of life (QoL) of men with low-risk prostate cancer (PCa) treated by different modalities and a reference group without PCa.Methods: In this cross-sectional study, four groups were sent a one-time QoL-questionnaire; PCa patients (1) following the structured Prostate cancer Research International Active Surveillance protocol, (2) who underwent radical prostatectomy (RP) in the context of the European Randomized study of Screening for Prostate Cancer-section Rotterdam, (3) who underwent radiotherapy (RT) at an academic hospital in The Netherlands, and (4) an age-matched reference group of men without PCa. The QoL-questionnaire addressed prostate-specific health (EPIC), generic health (SF-12), and anxiety (STAI-6). Statistical significance (p ≤ 0.05) and clinical relevance (≥0.5 SD) of differences between groups were assessed.Results: The AS, RP, RT, and reference group response rates amounted to 74% (122/165), 66% (70/106), 66% (221/335), and 75% (205/273), respectively. At a mean of 6.6 years of follow-up, active surveillance (AS)-men reported better urinary function [M = 93.0 (SD = 10.6) vs. 80.0 (SD = 19.1), p ≤ 0.001], less urinary incontinence [M = 90.0 (SD = 14.6) vs. 70.1 (SD = 28.8), p ≤ 0.001], and better sexual function [M = 40.9 (SD = 24.6) vs. 14.8 (17.7), p ≤ 0.001, clinically relevant] than RP-men. Compared to RT, AS-men reported better sexual function [M = 40.9 (SD = 24.6) vs. 25.8 (SD = 25.0), p = 0.069]. The four groups reported similarly low anxiety levels; the number of highly anxious men (STAI ≥ 44) ranged from 8 to 13%. For all QoL domains, men on AS and men without PCa reported very similar scores.Conclusions: Prostate-specific function of AS-men was significantly better than that of RP-men. When comparing AS to RT, a borderline significant difference in sexual function was seen. Men who followed an AS strategy for a long-term period were not anxious and accepted it well, suggesting that AS may be a good treatment option for men with low-risk PCa. [ABSTRACT FROM AUTHOR]

Study Type - Outcomes (cohort sample) Level of Evidence 2b What's known on the subject? and What does the study add? The study compares the sexual function of men with low-risk prostate cancer who chose active surveillance (expectant management) with similar men who received radiation therapy or radical prostatectomy. The first group appeared to be sexually active more frequently and had less erectile dysfunction. The study was non-randomized. No other studies exist on the effect of active surveillance on sexual function vs other treatment methods. OBJECTIVE To compare sexual function of men with localized prostate cancer (PCa) on active surveillance (AS) with similar patients who received radical therapy., PATIENTS AND METHODS Two groups of men with screening-detected localized PCa were compared. The first were men on AS within the prospective protocol-based Prostate Cancer Research International: Active Surveillance study. The second were men participating in the European Randomized Study of Screening for Prostate Cancer study who had received radical prostatectomy (RP) or radiation therapy (RT)., Questionnaires were completed at two different timepoints after diagnosis or treatment (6 and 12-18 months). These contained 10 items on sexual function, the mental and physical component summary from the Short-Form 12-item health survey, the Center for Epidemiologic Studies Depression scale depression measure and the State Trait Anxiety Inventory general anxiety measure., Sexual function was compared between groups, and determinants were analysed in multivariable analysis, adjusting for baseline differences., RESULTS A total of 65-68% of men on AS, 35-36% of those who underwent RP, 36-37% of those who underwent RT and 36% of men in the RP and RT groups combined (combined Tx) were sexually active., A total of 20-30% of men in the AS group, 86-91% of men in the RP group, 56-60% of men in the RT group and 71-76% of men in the combined Tx group were sexually inactive as a result of erectile dysfunction., A total of 44-51% of men in the AS group, 96% of men in the RP group, 73-76% of men in the RT group and 84-85% of men in the combined Tx group who were sexually active had problems getting or keeping an erection., In multivariable analysis these differences were significant, except for AS vs RT., CONCLUSIONS Men with localized PCa on AS were more often sexually active than similar men who received radical therapy, especially RP. If not sexually active, this was less often attributable to erectile dysfunction for those on AS. If sexually active, this was less often associated with problems getting or keeping an erection for those on AS., The study was non-randomized; the latest advances in RP and RT might impact results. [ABSTRACT FROM AUTHOR]

Purpose of the study: Given that screening for prostate cancer has the potential to reduce prostate cancer mortality at the expense of considerable overdiagnosis and overtreatment, the availability of core consumer information – correct, balanced and supportive of autonomous decision-making – is a must. We assessed the quality of consumer information available through the Internet per November 2009 and its possible contribution to informed decision-making by potential screenees. Methods: Consumer information on PSA-screening was sought through the Internet in November 2009. Materials had to be targeted at potential consumers, offered by not-for-profit organisations, released in 2005 or after, in English or Dutch. Per material 2 of the authors assessed independently from each other whether standardised pre-defined topics were addressed, whether the content was correct and which approach was taken towards the decision-making process about uptake. Results: Twenty-three materials were included, of which 11 were released (shortly) after the results of 2 large randomized-controlled trials (RCTs) that evaluated the effectiveness of screening for prostate cancer had been published in March 2009. That a PSA-test result can be abnormal because of non-cancerous conditions (false positive) and that it may miss prostate cancer (false negative) was not addressed in 2/23 and 8/23 materials, respectively. The risk of overdiagnosis and overtreatment was not mentioned in 6 out of 23. PSA-screening was presented as a usual thing to do in some materials, whereas other materials emphasised the voluntary nature of PSA-screening (‘it is your decision’). The content of 19/23 materials was considered sufficiently informative according to the pre-defined criteria, 12/23 materials were considered supportive of informed decision-making by men. Conclusions: Most materials of not-for-profit organizations supplied adequate information about PSA-screening, whilst the degree of persuasion towards uptake reflected variations in opinions on men’s autonomy regarding their own health. [Copyright &y& Elsevier]

Study Type – Therapy (outcomes research) Level of Evidence 2c 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. [ABSTRACT FROM AUTHOR]

Study Type – Survey (prospective cohort) Level of Evidence 1b OBJECTIVE To investigate the levels of knowledge of prostate cancer and the perception of active surveillance (AS) in men on AS, as AS for early prostate cancer instead of radical treatment might partly solve the over-treatment dilemma in this disease, but might be experienced as a complex and contradictory strategy by patients. PATIENTS AND METHODS In all, 150 Dutch men recently diagnosed with early prostate cancer participating in a prospective protocol-based AS programme (PRIAS study) received questionnaires, including a 15-item measure on their general knowledge of prostate cancer, and open-ended questions on the most important disadvantages and advantages of AS, and on the specific perception of AS. We assessed knowledge scores and explored potentially associated factors, the stated (dis)advantages and specific perceptions. RESULTS The questionnaire response rate was 86% (129/150). Participants provided correct answers to a median (interquartile range) of 13 (12–14) of 15 (87%) knowledge items. Younger and higher educated men had higher knowledge scores. In line with a priori hypotheses, the most frequently reported advantage and disadvantage of AS were the delay of side-effects and the risk of disease progression, respectively. Specific negative experiences included the feeling of losing control over treatment decisions, distress at follow-up visits, and the desire for a more active participation in disease management. No conceptually wrong understandings or expectations of AS were identified. CONCLUSIONS We found adequate knowledge of prostate cancer levels and realistic perceptions of the AS strategy in patients with early prostate cancer and on AS. These findings suggest adequate counselling by the physician or patient self-education. [ABSTRACT FROM AUTHOR]

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. [Copyright &y& Elsevier]

OBJECTIVES To determine how men treated for localized prostate cancer and who had permanent side-effects, and healthy controls, would value five descriptions of health states associated with side-effects of treatment for localized prostate cancer, hypothesising that patients would value the health states as less detrimental than men with no prostate cancer. PATIENTS, SUBJECTS AND METHODS In previous research, patients with prostate cancer reported high generic quality-of-life scores after primary treatment, despite side-effects; it was suggested that these patients accepted the side-effects, i.e. urinary, bowel and sexual dysfunction, as ‘part of the bargain’ because they felt they were saved from a life-threatening disease. Thus, we asked 54 men who had been treated for localized prostate cancer and had permanent side-effects, and 53 healthy controls, to value five descriptions of health states. All respondents valued all descriptions using two valuation methods, a visual analogue scale (VAS, range 0–100) and time trade-off (TTO, range 0–1). The respondent functioning was assessed using the EuroQol-5D, completed with items on urinary, bowel and sexual function. RESULTS Patients and healthy controls had similar valuations for nine of the 10 comparisons (five health states by two methods). Valuations in both groups resulted in the same ranking order of states on the TTO and one exchange in rank order on the VAS. CONCLUSIONS When asked to value five health states associated with side-effects of treatment for localized prostate cancer, there was no difference in the valuation of erectile, urinary and bowel dysfunction between patients with permanent side-effects after treatment and healthy controls. More likely explanations for the high generic quality-of-life scores after primary treatment for prostate cancer are a response shift and insensitivity of generic health-related quality-of-life measures. [ABSTRACT FROM AUTHOR]

Abstract: Because the introduction of PSA testing has increased the reported incidence of prostate cancer, this study assessed the mental impact on men after receiving a diagnosis of prostate cancer. Participants in a prostate cancer screening trial (ERSPC) completed a questionnaire on health and, if diagnosed with prostate cancer, at two additional time points. In the pre-screening phase 3800 men (response 88%) completed the questionnaire. Of screen-diagnosed men (n =82) 52 (response 63%) completed two additional assessments. Gleason scores were ⩽7 in 96% of men. Mental and self-rated overall health worsened significantly immediately after diagnosis (P ⩽0.04). Six months later these scores improved and no longer differed significantly from the pre-diagnosis score. After obtaining a pre-diagnosis assessment in prospective prostate cancer patients we found a significant negative mental impact of prostate cancer diagnosis based on PSA testing. We recommend that clinicians share their knowledge on the generally favourable prognosis with their patients. The methodological implication is that considering a post-diagnosis assessment as ‘baseline’ may lead to an underestimation of the patient’s mental health. [Copyright &y& Elsevier]

Objective: We aimed to assess to what extent men make informed choices in the context of prostate cancer screening and how written material contributes to that process.Methods: We developed a leaflet describing prostate cancer screening, and a questionnaire consisting of knowledge, attitude, and intended screening uptake components to assess informed decision-making. The leaflet and questionnaire were pilot-tested among men of the target population, adapted accordingly, and sent to 761 members of an online research panel. We operationalized whether the leaflet was read as spending one minute on the leaflet page and by a self-reported answer of respondents.Results: The response rate was 66% (501/761). The group who read the leaflet (n = 342) correctly answered a knowledge item significantly more often (10.9 versus 8.8; p < 0.001) than those who did not read the leaflet (n = 159), and made more informed choices (73% versus 56%; p = 0.001). There were no significant differences in attitude and intended screening uptake between both groups.Conclusion: Having read the leaflet could be one of the factors associated with increased levels of knowledge and informed decision-making.Practical Implications: The results of this study showed that increasing knowledge and supporting informed decision-making with written material are feasible in prostate cancer screening. [ABSTRACT FROM AUTHOR]

Background Literature on the health-related quality of life (HRQoL) for men with localized prostate cancer (PCa) on active surveillance (AS) shows a need for methodological guidance regarding HRQoL issues and how to address them. Objective The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies. Design, setting, and participants A modified Delphi study was used to reach consensus on AS HRQoL research topics and tools between 2014 and 2015. Data were collected by engaging a multidisciplinary team of 15 experts. Outcome measurements and statistical analysis An open-ended questionnaire was used to collect information from ESO TF members regarding issues in AS HRQoL research. Then a structured questionnaire was used to collect ratings on the usefulness/importance of different AS HRQoL aspects. Items that ≥80% of ESO TF members rated as useful/important were retained. Items with a 50–80% rating were discussed to reach final agreement. Results and limitations Six main research questions concerning the selection of outcome measures, measurement tools, and comparison groups were identified as relevant. The core set of measures identified were related to individual characteristics, psychological dimensions; decision-making–related issues, and physical functioning. The multidisciplinary expertise of ESO TF members was a significant asset, even if bringing different backgrounds to the discussion table represented a challenge. Conclusions HRQoL measures have to be sensitive to the specific needs of men on AS. The definition of HRQoL outcomes will enhance a broader understanding of the HRQoL of men on AS and sustain patient-centered medicine. Patient summary An international panel agreed on a set of health-related quality-of-life aspects to be assessed among men on active surveillance for prostate cancer. Valid relevant questionnaires were identified. The experts’ indications lay a foundation for future research and clinical practice. [ABSTRACT FROM AUTHOR]

Context The optimal management of screen-detected, localised prostate cancer remains controversial, related to overtreatment issues of screening and the nonrandomised evidence base. Active surveillance (AS) aims to delay or avoid curative therapy but may potentially harm patients’ well-being through living with untreated prostate cancer. Objective To systematically review the literature on quality of life (QoL) in patients undergoing AS. Evidence acquisition Embase, Medline, Psychinfo, Cochrane Central, Web of Science, and PubMed databases were searched in May 2014 using quality of life , active surveillance , prostate cancer , their synonyms, and targeted manual searches. The psychological dimensions related to health-related QoL (HRQoL) outcomes were anxiety and depression, distress, decisional conflict, and mental health. Evidence synthesis Ten clinical and research-based AS studies worldwide measured HRQoL and related psychological facets in six cross-sectional studies and four cohorts (follow-up: 9–36 mo; published: 2006–2014). Six studies were linked to published AS cohorts. In total, 966 men undergoing AS (mean: 102 per study) were assessed (mean age: 66 yr). AS patients had good overall HRQoL scores, which were comparable or better than those of patients undergoing postradical treatment (comparator group in four studies), men's partners (one study) and population-based data (three studies). Anxiety and depression scores were favourable. Selection bias may be present, as none were randomised comparisons. Decreased psychological well-being may be partly predicted by AS patients’ baseline and clinical characteristics. Conclusions Patients undergoing AS reported good QoL and did not appear to suffer major negative psychological impacts. Longer follow-up is required as well as investigation into which patients are predisposed to negative impact and leaving AS prematurely. Patient summary We reviewed the published evidence for quality-of-life impact on men with prostate cancer being monitored by active surveillance. The men who were on active surveillance usually reported good levels of well-being and did not appear to suffer major negative psychological impacts. The research findings suggest little presence of anxiety and depression and high overall quality of life related to their disease. However, there are few long-term studies, so more high-quality research is needed to make definitive recommendations. [ABSTRACT FROM AUTHOR]

Abstract: Active surveillance (AS) is an important management strategy for men diagnosed with low-risk prostate cancer (PCa). The need for AS is increasing due to the awareness that many PCa are identified that show a low growth potential and therefore are likely to remain clinically asymptomatic during the lifetime of an individual. Currently there is no good method to prevent the overdiagnosis of indolent cancers upfront. During the last decade, several studies on AS around the world have made observations that feed the discussion on how to select and monitor these patients, how to proceed with the research to develop a better and more precise clinical definition of indolent cancers and how to manage men under AS clinically. Furthermore, patients’ perspectives have become clearer, and quality of life studies give direction to the practical approach and care for patients and partners. This paper reflects the consensus on the state of the art and the future direction of AS, based on the Inside Track Conference “Active Surveillance for low risk prostate cancer” (Chairmen: C.H. Bangma, NL, and L. Klotz, CA; Co-Chairmen: L.J. Denis, BE, and C. Parker, UK; Scientific Coordinators: M. J. Roobol, NL, and E.W. Steyerberg, NL), organized by the European School of Oncology in collaboration with Europa Uomo in Rotterdam, the Netherlands in January 2012. Topics for discussion were the optimisation of patient selection based on indolent disease definition, the incorporation of therapeutic agents into AS programs, the optimisation of patient care, and the application of emerging technologies and biomarkers. [Copyright &y& Elsevier]

Background: After 11 years of follow-up, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported a 29% reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen (PSA) levels. However, the extent to which harms to quality of life resulting from overdiagnosis and treatment counterbalance this benefit is uncertain. Methods: On the basis of ERSPC follow-up data, we used Microsimulation Screening Analysis (MISCAN) to predict the number of prostate cancers, treatments, deaths, and quality-adjusted life-years (QALYs) gained after the introduction of PSA screening. Various screening strategies, efficacies, and quality-of-life assumptions were modeled. Results: Per 1000 men of all ages who were followed for their entire life span, we predicted that annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer (28% reduction), 14 fewer men receiving palliative therapy (35% reduction), and a total of 73 life-years gained (average, 8.4 years per prostate-cancer death avoided). The number of QALYs that were gained was 56 (range, −21 to 97), a reduction of 23% from unadjusted life-years gained. To prevent one prostate-cancer death, 98 men would need to be screened and 5 cancers would need to be detected. Screening of all men between the ages of 55 and 74 would result in more life-years gained (82) but the same number of QALYs (56). Conclusions: The benefit of PSA screening was diminished by loss of QALYs owing to postdiagnosis long-term effects. Longer follow-up data from both the ERSPC and quality-of-life analyses are essential before universal recommendations regarding screening can be made. (Funded by the Netherlands Organization for Health Research and Development and others.) [ABSTRACT FROM PUBLISHER]

Abstract: Background: Population-based screening for prostate cancer (PCa) remains controversial. To help men making informed decisions about prostate specific antigen (PSA) screening a risk indicator (www.uroweb.org) was developed. This risk indicator is embedded in a leaflet that informs men about the pros and cons of PCa screening and enables calculation of the individual risk of having a biopsy detectable PCa. Aim: To assess the effect of providing a leaflet including individualized risk estimation on informed decision making of men, i.e. knowledge about PCa and PSA screening, attitude towards undergoing a PSA test and intention to have a PSA test. Methods: An intervention study among 2000 men, aged 55–65years, randomly selected from the population registry of the city of Dordrecht, the Netherlands, in 2008. Men were sent a questionnaire on knowledge of PCa, attitude and intention to have a PSA test. Men without a history of (screening for) PCa were sent the leaflet and Questionnaire 2 within 2weeks after returning Questionnaire 1. Validated health and anxiety measures were used. Results: One thousand and twenty seven of 2000 men completed Questionnaire 1 (51%), of whom 298 were excluded due to a history of (screening for) PCa. Of the 729 remaining men, 601 completed Questionnaire 2 as well. At the second assessment significantly more men met the requirements of informed decision making (15% versus 33%, p <0.001), more men had relevant knowledge (284/601, 50% versus 420/601, 77%, p <0.001) and the intention to have a PSA test had increased (p <0.001). Conclusions: Providing information on PCa screening combined with individualized risk estimation enhanced informed decision making and may be used for shared decision making on PSA screening of physicians and patients. [Copyright &y& Elsevier]