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Narrating illness experiences in a culturally acceptable manner is essential for retaining quality of life after the disruptive event of being diagnosed for prostate cancer. Psychological pressures caused by treatment side-effects such as erectile dysfunction require reinterpretation of the meanings and impacts of these side-effects on masculinity. This helps maintain coherence in men's lives. We studied how men employ culturally available discursive strategies (compensation, redefinition, recontextualisation, and normalisation) in reconstructing masculinity and sexuality. Our data consists of 22 interviews of heterosexual Finnish prostate cancer patients who had undergone surgery. The aim was to analyse the ways in which various life situations and social relations shaped and limited the use of these strategies. Discourse analysis revealed that older age, a supportive spouse, children, supportive male friends, and good health - were key elements men used in reconstructing a coherent new self-image and conception of life following cancer treatment. Men with sexually active male friends, men without families, younger men and men with new intimate relationships struggled to develop a new version of their masculinity. Being able to effectively utilise certain aspects of one's life situation in re-constructing masculinity is important in maintaining quality of life despite troublesome treatment side-effects.

Introduction: This study investigates comments that prostate cancer patients spontaneously write in the margins of the Expanded Prostate Cancer Index Short Form (EPIC-26) questionnaire. We aim to show the possible barriers that patients face while answering the survey, and to consider how these barriers may affect the response data generated. We investigate the kind of information patients' comments on EPIC-26 contain, and patients' motivations to provide this information. We also study why some EPIC domains spark more comments than others., Method: We analyzed 28 pages of transcribed comments and four pages of supplementary letters from our survey participants (n = 496). Using inductive content analysis, we generated 10 categories describing the content of participants' comments, and four themes demonstrating their motives for commenting. The comments regarding each EPIC domain were quantified to discover any differences between domains., Results: The sexual domain of EPIC-26 provoked over half of all comments. Patients without recent sexual activity or desire had difficulties answering sexual function questions 8-10. The lack of instructions on whether to take erectile aid use into account when answering erectile function questions led to a diversity of answering strategies. Patients with urinary catheters could not find suitable answer options for questions 1-4. All domains sparked comments containing additional information about experienced symptoms., Conclusion: Patients are mainly willing to report their symptoms, but a lack of suitable answer options causes missing data and differing answering strategies in the sexual and urinary domains of EPIC-26, weakening the quality of the response data received., (© 2021. The Author(s).)

Background: In the ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT significantly improved metastasis-free survival (MFS), overall survival (OS) and time to pain progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Herein, we present analyses of patient-reported health-related quality of life (HRQoL) outcomes., Patients and Methods: This double-blind, placebo-controlled, phase III trial randomised patients with nmCRPC and prostate-specific antigen doubling time ≤10 months to darolutamide 600 mg (n = 955) twice daily or matched placebo (n = 554) while continuing ADT. The primary end-point was MFS; the secondary end-points included OS and time to pain progression. In this analysis, HRQoL was assessed by the time to deterioration using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) prostate cancer subscale (PCS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25) subscales., Results: Darolutamide significantly prolonged time to deterioration of FACT-P PCS versus placebo (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.70-0.91; P = 0.0005) at the primary analysis (cut-off date: 3rd September 2018). Time to deterioration of EORTC QLQ-PR25 outcomes showed statistically significant delays with darolutamide versus placebo for urinary (HR 0.64, 95% CI 0.54-0.76; P < 0.0001) and bowel (HR 0.78, 95% CI 0.66-0.92; P = 0.0027) symptoms. Time to worsening of hormonal treatment-related symptoms was similar between the two groups., Conclusion: In patients with nmCRPC who are generally asymptomatic, darolutamide maintained HRQoL by significantly delaying time to deterioration of prostate cancer-specific quality of life and disease-related symptoms versus placebo., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MRS has received grants and personal fees from Bayer, Amgen, Janssen and Lilly, and personal fees from Astellas Pharma, Novartis and Pfizer. NS has received personal fees and non-financial support from Bayer and Janssen, personal fees from Tolmar, Ferring, Medivation, Amgen, Pfizer, AstraZeneca, Genentech/Roche, Myovant Sciences, Astellas Pharma and Merck, and non-financial support from Dendreon. TLT has received grants from Bayer, Lidds AB and Astellas Pharma, and personal fees from Janssen. AU and SP have no conflicts of interest to disclose. EV has received grants and personal fees from Orion Pharma, and grants from Bayer, Ipsen and Janssen. MJ has received grants from Bayer, Ipsen and Janssen. ML has received grants, personal fees and non-financial support from Bayer and Janssen, personal fees and non-financial support from Astellas Pharma, non-financial support from Roche and grants from Medivation, Myovant Sciences and Pfizer. BA has received grants, personal fees and non-financial support from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Ferring, Janssen, MSD, Pfizer and Sanofi, and grants from Bavarian Nordic and Icon clinical Research. IK is an employee of Bayer AG. MA-LB and AFM are employees of Bayer HealthCare. DO and JB are employees of the Research Triangle Institute Health Solutions. AS and TS are employees of Orion Pharma. KF has received personal fees and non-financial support from Janssen and Amgen, and personal fees from Bayer, Astellas Pharma, Sanofi, Orion Pharma, Curevac, AstraZeneca, ESSA and Roche., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The long-term health-related quality of life (HRQOL) impacts of PCa screening have not been adequately evaluated. We aimed to compare the generic and disease-specific health-related quality of life (HRQOL) among men with prostate cancer in the screening arm with the control arm of the PSA-based prostate cancer screening trial in up to 15 years of follow-up., Materials and Methods: This study was conducted within population-based Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC). During 1996-1999 80,458 men were randomized to the serum prostate-specific antigen (PSA) screening arm (SA, N = 32 000) and the control arm (CA, N = 48 458). Men in the screening arm were screened at 4-year intervals until 2007. HRQOL questionnaires were delivered to newly diagnosed prostate cancer patients in the screening and control arm 1996-2006 (N = 5128) at the time of diagnosis (baseline), at 3-month, 12-month and 5, 10, and 15-year follow-up. Validated UCLA Prostate Cancer Index (UCLA-PCI) and RAND 36-Item Health Survey were used for HRQOL assessment. The data were analyzed with a random effects model for repeated measures., Results: At baseline, men with prostate cancer in the screening arm reported better Sexual Function, as well as less Sexual and Urinary Bother. Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005). The generic HRQOL scores were comparable between the trial arms. The overall differences in disease-specific or generic HRQOL scores by trial arm did not vary during the follow-up., Conclusion: No major differences were observed in HRQOL in men with prostate cancer between the prostate cancer screening and control arms during five to 15-year follow-up., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: Localised prostate cancer affects patient's quality of life in many ways. The aim of this study was to explore factors related to self-rated health and life satisfaction for patients treated for prostate cancer, and to compare the results of these generic quality-of-life measures to the prostate cancer-specific quality-of-life measure (UCLA Prostate Cancer Index), which focuses on physical functioning., Material and Methods: This cross-sectional survey was carried out among 183 men who underwent radical prostatectomy in 2012-2015 at a university hospital in Finland and were seen 1 year postsurgery. Approval from an ethics committee and written consents from participants were received. A questionnaire was used to evaluate patients' perceived quality of life. Logistic regression model, Spearman's correlation, Kruskal-Wallis test and Mann-Whitney U-test were used to analyse factors related to quality of life., Results: Of the 183 men in the study, 63% rated their health status as good, and 70% were satisfied with their lives after prostatectomy. Older age and better urinary function were the only factors that explained both better self-rated health and better satisfaction with life. The patients seemed not to interpret problems with sexual function as health-related problems. In our sample, sexual dysfunction was relatively severe, but patients considered them to be less harmful than urinary or bowel symptoms. Interestingly, 24% of the men with low sexual function did not find that dysfunction bothersome., Conclusions: Objectively measured physical functioning is not necessarily in line with patients' experienced satisfaction with life and their self-ratings of health. More longitudinal and qualitative research is needed about the meanings that patients attach to physical treatment side effects and the extent to which they can adapt to them over time. With a bigger sample and longer follow-up time, it would be possible to identify men who particularly benefited from pretreatment counselling., (© 2019 Nordic College of Caring Science.)

Objective: The aim of the study was to compare intermittent (IAD) and continuous (CAD) androgen deprivation therapy (ADT) between locally advanced (M0) and metastatic (M1) prostate cancer, and the effect of ADT on the quality of life., Material and Methods: In total, 852 men with advanced prostate cancer were enrolled to receive goserelin acetate for 24 weeks. Of these, 554 patients whose prostate-specific antigen (PSA) decreased to less than 10 ng/ml or by at least 50% (<20 ng/ml at baseline) were randomized to IAD or CAD. In the IAD arm, ADT was resumed for at least 24 weeks whenever PSA increased to greater than 20 ng/ml or above baseline., Results: Median follow-up time was 65 months. Median times from randomization to progression, death, prostate cancer death and treatment failure in M0 and M1 patients were 46.8 and 21.4, 57.6 and 40.3, 59.5 and 40.7, and 41.9 and 20.0 months, respectively (p < 0.001). No significant differences emerged between IAD and CAD. ADT showed a beneficial effect on pain, activity limitation and social functioning in M1 patients, and a deleterious effect on physical capacity in M0 patients and on sexual functioning in both groups. IAD offered extra benefit for activity limitation, social functioning and recovery of sexual functioning., Conclusions: IAD is as efficient as CAD in treatment of locally advanced and metastatic prostate cancer. ADT improves quality of life in M1 patients, with IAD offering extra benefit.

Background: Evidence of the potential impact of systematic screening for prostate cancer (PCa) on health-related quality of life (HRQoL) at a population-based level is currently scarce., Objective: This study aims to quantify the long-term HRQoL impact associated with screening for PCa., Design, Setting, and Participants: Postal questionnaire surveys were conducted in 1998, 2000, 2004, and 2011 among men in the Finnish PCa screening trial diagnosed with PCa (total n=7011) and among a random subsample of the trial population (n=2200). In 2011, for example, 1587 responses were received from men with PCa in the screening arm and 1706 from men in the control arm. In addition, from the trial subsample, 549 men in the screening arm and 539 in the control arm provided responses., Outcome Measurements and Statistical Analysis: Health-state-value scores were compared between the intervention and control arms using three distinct HRQoL measures (15D, EQ-5D, and SF-6D), and statistical significance was assessed using t tests. In addition, differences over repeated assessments of HRQoL between groups were evaluated using generalised estimating equations., Results and Limitations: In the 2011 survey, a small but statistically significant difference emerged between the trial arms among men diagnosed with PCa (mean scores, screening vs control arm: 15D: 0.872 vs 0.866, p=0.14; EQ-5D: 0.852 vs 0.831, p=0.03; and SF-6D: 0.763 vs 0.756, p=0.06). Such differences in favour of the screening arm were not found among the sample of men from the trial (15D: 0.889 vs 0.892, p=0.62; EQ-5D: 0.831 vs 0.852, p=0.08; and SF-6D: 0.775 vs 0.777, p=0.88). The slight advantage with screening among men with PCa was reasonably consistent across time in the longitudinal analysis and was strongest among men with early-stage disease., Conclusions: These results show some long-term HRQoL benefit from screening for men with PCa but suggest little impact overall in the trial population., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: As prostate cancer (PC) mortality reduction results are not unequivocal, a special emphasis has to be put on other aspects of the prostate-specific antigen (PSA) screening, including effects on quality of life. In the present study we describe the short-term effects of various phases of PC screening on health-related quality of life (HRQL)., Material and Methods: The study participants were randomized into the screening arm within the Finnish component of the European Randomized Study on Screening for Prostate Cancer (ERSPC). The RAND 36-Item Health Survey on HRQL and questionnaires on sociodemographic and behavioral factors were delivered to participants at various phases of the first screening round: 1) 500 participants at invitation; 2) 500 after screening; 3) 500 after obtaining the PSA result; 4) to 300 participants after undergoing digital rectal examination (DRE) (but prior to being informed of its result); and 5) approximately 300 after prostate biopsy. At each stage, a new sample of participants was recruited., Results: Response rates were 59% at invitation, 77% after PSA blood test, 54% after PSA result and 69% after DRE. The men recruited at each stage were comparable in respect to socioeconomic variables. The HRQL scores in RAND-36 subscales showed little variation in the different phases of the screening process. Compared with the previous phase, the social function score was slightly lower after obtaining the PSA result than after blood test, the emotional role score lower after DRE than after PSA result and the pain-related score lower after DRE than after TRUS and biopsy. The screening participants were comparable to the general population as their HRQL scores were similar to an age-stratified general Finnish male population., Conclusion: Short-term HRQL effects of prostate cancer screening appear minor and transient.

Introduction: The clinical significance of low to low-normal testosterone (T) levels in men remains debated., Aim: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL)., Methods: Randomized, double-blind, placebo-controlled study. Men, aged 50-80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males' Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5-7.5 mg/day; n =183) or placebo gel (n =179), followed by 12 months open-label with T in all., Results: After 6 months, LBM increased in T- treated patients by 1.28 ± 0.15 kg (mean ± SE) and FM decreased by 1.16 ± 0.16 kg, with minor changes with placebo (LBM +0.02 ± 0.10 kg and FM -0.14 ± 0.12 kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo)., Conclusions: Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.

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.).

Background: Wide variation exists in prevalence estimates of overactive bladder (OAB) syndrome., Objective: To determine how the frequency of urinary urgency or urgency urinary incontinence (UUI)--the cornerstone symptoms of OAB--affects symptom-related bother, health-related quality of life (HRQL), and ultimately clinically meaningful prevalence., Design, Setting, and Participants: Questionnaires were mailed to 6000 subjects (18-79 yr of age) randomly identified from the Finnish Population Register in 2003-2004., Measurements: The frequency (scale: never, rarely, often, always) and bother (scale: none, small, moderate, major) of urgency and UUI were assessed using the Danish Prostatic Symptom Score (DAN-PSS). HRQL was measured with the generic 15D instrument. For HRQL analyses, respondents were classified according to six symptom categories by frequency of urgency and UUI., Results and Limitations: Of those subjects queried, 62.4% responded to the survey (53.7% female). Any urgency was reported by more than half of all respondents (54.2% [95% confidence interval (CI), 51.6-56.7] of men; 56.9% [95% CI, 52.9-61.0] of women), whereas any UUI was reported by one in nine men (10.7% [95% CI, 8.9-12.4]) and one in four women (25.7% [95% CI, 22.8-28.7]). However, only one in seven of all respondents with urgency and less than one in three with UUI reported at least moderate bother. With increasing OAB severity, statistically significant decreases were found in the total 15D score and on all 15D dimensions (p<0.001 for all). Reporting often urgency without UUI or rare urgency with rare UUI is associated with a clinically important decrease in HRQL. Although the response proportion was high, approximately one-third of those contacted did not participate., Conclusions: Increased severity of urgency and UUI is associated with a statistically significant and clinically important decrease in HRQL. Assessing bother associated with OAB drastically modifies the measured OAB prevalence and accounts for variation among studies., (Copyright © 2011 European Association of Urology. All rights reserved.)

Objective: To evaluate attitudes to prostate cancer screening with prostate-specific antigen (PSA) of men who complied with offered screening and those who declined it within the Finnish randomized population-based screening trial, and to compare general health-related quality of life (HRQL) between participants and non-participants., Subjects and Methods: Self-administered questionnaires were sent to 500 men randomized into the screening arm in 1996-99 within the Finnish component of the European Randomized Study on Screening for Prostate Cancer. A similar survey was conducted among 500 non-participants., Results: Response proportions among the screening participants and non-participants were 59% and 28%, respectively. Current smoking was less frequent (P < 0.05) among the participants. In terms of attitude, the participants regarded the prostate cancer study as more important and the invitation letter as more informative than the non-participants (P < 0.001). There was no clear difference in worry about treatment consequences. The most commonly given reasons for not participating included previous PSA testing (41%), forgetting the invitation (51%), or not wanting to think of prostate cancer (39%) and regarding possible further diagnostic examinations as unpleasant (28%). The non-participants had a lower mental health score (P < 0.001) than the participants in the RAND-36 Survey., Conclusion: Most men who chose not to attend screening had a positive attitude, but did not participate due to practical reasons. However, two-thirds of the non-participants indicated a willingness to participate in the next screening round.

Background: Nocturia (ie, waking at night to void) is common and disrupts sleep. Traditionally, one nightly episode has been regarded as clinically meaningless, yet the justification for this belief remains weak., Objective: To evaluate the association among frequency of nocturia and bother and health-related quality of life (HRQoL)., Design, Setting, and Participants: In 2003-2004, a survey was mailed to a random sample of 6000 subjects aged 18-79 yr who were identified from the Finnish Population Register Centre (response proportion was 62.4%; 53.7% were females)., Measurements: HRQoL and bother from nocturia were examined in relation to self-reported nocturia frequency (using the American Urological Association Symptom Index and the Danish Prostatic Symptom Score). Bother from nocturia was assessed on a four-point scale (none, small, moderate, major). HRQoL was measured with the generic 15D instrument on a 0-1 scale with a minimum clinically important difference of 0.03., Results and Limitations: Degree of bother increased with nocturia frequency (p<0.01). The most commonly cited degree of bother for those with one, two, and three nightly voids was no bother, small bother, and moderate bother, respectively. The mean age-adjusted 15D score for men (and women) without nocturia was 0.953 (0.950) and 0.925 (0.927) with one void per night, 0.898 (0.890) with two voids per night, and 0.833 (0.840) with three or more voids per night. Statistically significant decreases were found in 15D score and in all 15D dimensions except eating. Although the response rate was high, approximately one third of those contacted did not participate in the study., Conclusions: At least two voids per night is associated with impaired HRQoL. The majority of people report having bother when the number of nocturia episodes is two and moderate or major bother when the number is three or more. One void per night does not identify subjects with interference from nocturia and, thus, is not a suitable criterion for clinically relevant nocturia., (2009 European Association of Urology. All rights reserved.)

Objective: Painful bladder syndrome/interstitial cystitis (PBS/IC) is an inflammatory bladder disease of unknown origin. Symptoms of PBS/IC compromise patients' quality of life (QoL). This study evaluated a health-related quality of life (HRQoL) questionnaire in PBS/IC., Material and Methods: 151 patients with PBS/IC filled in the HRQoL questionnaire before and after the treatment. Of these, 87 patients participated in a 3-month randomized study testing intravesical dimethyl sulfoxide (DMSO) and bacille Calmette-Guerin (BCG) and 64 patients took part in a 6-month randomized study evaluating oral cyclosporine A (CyA) and pentosan polysulfate sodium (PPS). The changes in HRQoL questionnaire were evaluated with respect to the changes in global response assessment (GRA)., Results: The results of the HRQoL questionnaire reflected well the post-treatment GRA. Patients responding to their treatment had improved QoL. CyA treatment had more impact on emotional well-being, social functioning, activity limitation days, pain and physical capacity than PPS treatment (p<0.05). More patients responded to DMSO than BCG treatment according to GRA (p<0.01), but the results in HRQoL questionnaire were equal after DMSO and BCG treatments., Conclusions: The HRQoL questionnaire can be used in evaluating QoL in PBS/IC patients. Treatment of PBS/IC had obvious effects on QoL.

Objective: To describe changes in the prevalence and severity of urinary symptoms and the degree of interference they cause in the daily life of the Finnish male population by means of a 5-year follow-up study., Material and Methods: A postal survey of a stratified random population sample of elderly men in Pirkanmaa County was carried out in 1994 and 1999. A total of 3143 men in 1994 and 2837 in 1999 received the questionnaire; 2198 (70%) and 2133 (75%) responded, respectively. The questionnaire included items on sociodemographic status, overall health and diseases, urinary symptoms (Danish Prostatic Symptom Score), sexual function and bothersomeness of symptoms. Data from those individuals who responded adequately to both inquiries were analysed., Results: The most prevalent urinary symptoms were post-micturition dribble (64%), nocturia (62%), hesitancy (50%) and incomplete emptying (46%). At the 5-year follow-up, the prevalences of hesitancy, incomplete emptying, nocturia, urge incontinence and stress incontinence had increased statistically significantly. Subjects who had been symptomatic at baseline reported no change in 46-77% of cases, deterioration in 2-19% and improvement in 16-52%. The degree of interference in daily activities due to urinary symptoms increased significantly during follow-up. The mean interference index increased from 2.3 to 4.4., Conclusion: Although urinary symptoms in elderly males are particularly common and their prevalence increases with age, they are mostly mild and also have a marked tendency to improve with time. The total burden of urinary symptoms nonetheless increases with age in the elderly male population.

Purpose: Screening for prostate cancer may have limited impact on decreasing prostate cancer-related mortality. A major disadvantage is overdiagnosis, whereby lesions are identified that would not have become evident during the man's lifetime if screening had not taken place. The present study aims to estimate the rate of overdiagnosis using Finnish data from the European randomized trial of prostate cancer screening. Methods: We used data from 80,149 men randomized to a screening or a control group, distinguishing four birth cohorts. We used the "catch-up method" to identify when the difference in the cumulative incidence of prostate cancer between the screening and control groups had stabilized, implying that the screening has no further effect. We define the overdiagnosis rate to be the relative excess cumulative incidence in the screened group at that point. As an independent method, we also examined the diagnosis rates of T1c tumors as an indicator of early tumors detected by PSA. Results: The estimates of overdiagnosis rates from the catch-up method using the full period of available follow-up ranged between cohorts from 2.3% to 15.4%, and the T1c analysis gave very similar results. Conclusion: Some overdiagnosis has occurred, but there is uncertainty about its extent. A long follow-up is required to demonstrate the full impact of screening. We evaluated the overdiagnosis rates at a population level, associated with being offered screening, taking account of contamination (screening among the controls). The overall evaluation of screening should incorporate mortality benefit, cost-effectiveness, and quality of life. [ABSTRACT FROM AUTHOR]

We studied experiences and psychological distress of partners of prostate cancer patients at the time of diagnosis and primary treatment and investigated associates of their psychological wellbeing and the emotional social support they give to and receive from the patient. Using a quantitative questionnaire we studied the spouses’ experiences (psychological response and sources of information and emotional support at diagnosis; impacts of prostate cancer on partnership and sex life; impact of side effects of treatment) and the emotional support given and received, and measured their psychological symptom distress. Many spouses reported distressing experiences and all psychological symptoms. Two thirds perceived no impact of the cancer on the partnership while 29% no change in sex life. Distress was associated with a shock, fear of the man's death and impact of side effects, whereas emotional support from a doctor predicted less distress. More support given to the patient was associated with information and emotional support received from a doctor and the patient's sexual dysfunction and pain, and less with experiences of depression, no impact on the partnership and the patient's irritableness. The spouses’ distress was relieved by emotional support from a doctor, which along with received information also enhanced their capability to support the patient. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the long-term safety (primary objective) and efficacy/impact on quality of life (QoL, secondary objectives) of silodosin 8 mg once daily in men with LUTS/BPH. Patients and Methods: Men who completed the 12-week double-blind study with silodosin 8 mg, tamsulosin 0.4 mg, or placebo were offered to continue with the 9-month open-label study during which all patients received silodosin 8 mg once daily. Safety was assessed by analysing vital signs, electrocardiograms, laboratory tests, and adverse events. Efficacy was evaluated with the International Prostate Symptom Score (IPSS), IPSS voiding and storage sub-scores, IPSS-QoL, and maximum urinary flow rate ( Q). Results: A total of 500 patients (mean age 66 years) entered the 9-month open-label study. Treatment-emergent adverse events (TEAE) were experienced by 33.4 % patients. Ejaculation dysfunction was the most common TEAE (9.0 %) but led to study discontinuations in only 1.6 % of patients. Dizziness without orthostatic hypotension occurred in 0.8 %. A marked reduction in total IPSS (−2.7 ± 3.8) was documented at the first visit of this extension phase in patients having de novo silodosin compared with lesser improvement in patients previously treated with silodosin (−0.82 ± 4.2) or tamsulosin (−0.83 ± 3.8). Improvements were maintained throughout the open-label phase. QoL also improved, with the greatest improvement in de novo silodosin patients. No relevant changes in Q occurred. Conclusions: Long-term treatment with silodosin was safe and efficacious. Abnormal ejaculation was the most common TEAE, but led to treatment discontinuation in only 1.6 % of patients. Orthostatic hypotension was not seen, and only a few patients experienced dizziness. [ABSTRACT FROM AUTHOR]

In patients with prostate-specific antigen doubling time >6–≤10 mo who are at a risk of progression to metastatic disease, darolutamide significantly improved metastasis-free survival, overall survival, and other patient-relevant endpoints versus placebo, without undue toxicity burden or adversely affecting health-related quality of life. Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) have a high risk of progression to metastatic disease, particularly if their prostate-specific antigen doubling time (PSADT) is ≤6 mo. However, patients remain at a high risk with a PSADT of >6 mo. To evaluate the efficacy and safety of darolutamide versus placebo in patients stratified by PSADT >6 or ≤6 mo. A planned subgroup analysis of a global multicenter, double-blind, randomized, phase 3 trial in men with nmCRPC and PSADT ≤10 mo was conducted. Patients were randomized 2:1 to oral darolutamide 600 mg twice daily or placebo, while continuing androgen-deprivation therapy. The primary endpoint was metastasis-free survival (MFS). Secondary endpoints were overall survival (OS) and times to pain progression, first cytotoxic chemotherapy, and symptomatic skeletal events. Quality of life (QoL) was measured using validated prostate-relevant tools. Safety was recorded throughout the study. Of 1509 patients enrolled, 469 had PSADT >6 mo (darolutamide n = 286; placebo n = 183) and 1040 had PSADT ≤6 mo (darolutamide n = 669; placebo n = 371). Baseline characteristics were balanced between subgroups. Darolutamide significantly prolonged MFS versus placebo in both subgroups (unstratified hazard ratio [95% confidence interval]: PSADT >6 mo, 0.38 [0.26–0.55]; PSADT ≤6 mo, 0.41 [0.33–0.52]). OS and other efficacy and QoL endpoints favored darolutamide with significant improvement over placebo in both subgroups. The incidence of adverse events, including events commonly associated with androgen receptor inhibitors (fractures, falls, hypertension, and mental impairment), and discontinuations due to adverse events were low and similar to placebo. Limitations include small subgroup populations. In patients with nmCRPC and PSADT >6 mo (maximum 10 mo), darolutamide provided a favorable benefit/risk ratio, characterized by significant improvements in MFS, OS, and other clinically relevant endpoints; maintenance of QoL; and favorable tolerability. In patients with prostate cancer that has stopped responding to standard hormonal therapy (indicated by an increase in prostate-specific antigen [PSA] levels), there is a risk that the cancer will spread to other parts of the body. This risk is highest when the time it takes for the PSA level to double (ie, "PSA doubling time" [PSADT]) is less than 6 mo. However, there is still a risk that the cancer will spread even if the PSADT is longer than 6 mo. In a group of patients whose PSADT was more than 6 mo but no more than 10 mo, treatment with darolutamide slowed the cancer spread and allowed them to live longer than patients who received placebo (inactive drug). Darolutamide treatment did not cause many side effects and helped maintain patients' quality of life without disruptions. [ABSTRACT FROM AUTHOR]

Abstract: Background: Silodosin is a new selective therapy with a high pharmacologic selectivity for the α1A-adrenoreceptor. Objective: Our aim was to test silodosin''s superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin. Design, setting, and participants: We conducted a multicenter double-blind, placebo- and active-controlled parallel group study. A total of 1228 men ≥50 yr of age with an International Prostate Symptom Score (IPSS) ≥13 and a urine maximum flow rate (Qmax) >4 and ≤15ml/s were selected at 72 sites in 11 European countries. The patients were entered into a 2-wk wash-out and a 4-wk placebo run-in period. A total of 955 patients were randomized (2:2:1) to silodosin 8mg (n =381), tamsulosin 0.4mg (n =384), or placebo (n =190) once daily for 12 wk. Measurements: We calculated the change from baseline in IPSS total score (primary), storage and voiding subscores, quality of life (QoL) due to urinary symptoms, and Qmax. Responders were defined on the basis of IPSS and Qmax by a decrease of ≥25% and an increase of ≥30% from baseline, respectively. Results and limitations: The change from baseline in the IPSS total score with silodosin and tamsulosin was significantly superior to that with placebo (p <0.001): difference active placebo of −2.3 (95% confidence interval [CI], −3.2, −1.4) with silodosin and −2.0 (95% CI,−2.9, −1.1) with tamsulosin. Responder rates according to total IPSS were significantly higher (p <0.001) with silodosin (66.8%) and tamsulosin (65.4%) than with placebo (50.8%). Active treatments were also superior to placebo in the IPSS storage and voiding subscore analyses, as well as in QoL due to urinary symptoms. Of note, only silodosin significantly reduced nocturia versus placebo (the change from baseline was −0.9, −0.8, and −0.7 for silodosin, tamsulosin, and placebo, respectively; p =0.013 for silodosin vs placebo). An increase in Qmax was observed in all groups. The adjusted mean change from baseline to end point was 3.77ml/s for silodosin, 3.53ml/s for tamsulosin, and 2.93ml/s for placebo, but the change for silodosin and tamsulosin was not statistically significant versus placebo because of a particularly high placebo response (silodosin vs placebo: p =0.089; tamsulosin vs placebo: p =0.221). At end point, the percentage of responders by Qmax was 46.6%, 46.5%, and 40.5% in the silodosin, tamsulosin, and placebo treatment groups, respectively. This difference was not statistically significantly (p =0.155 silodosin vs placebo and p =0.141 tamsulosin vs placebo). Active treatments were well tolerated, and discontinuation rates due to adverse events were low in all groups (2.1%, 1.0%, and 1.6% with silodosin, tamsulosin, and placebo, respectively). The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm (14%), a reversible effect as a consequence of the potent and selective α1A-adrenoreceptor antagonism of the drug. The incidence was higher than that observed with tamsulosin (2%); however, only 1.3% of silodosin-treated patients discontinued treatment due to this adverse event. Conclusions: Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia. Its overall efficacy is not inferior to tamsulosin. Only silodosin showed a significant effect on nocturia over placebo. Trial registration: ClinicalTrials.gov Identifier NCT00359905. [Copyright &y& Elsevier]

Background The multicenter European Randomized Study of Screening for Prostate Cancer has shown a 21% reduction in prostate cancer (PC) mortality by prostate-specific antigen-based screening, with substantial overdiagnosis. In the present study, we analyzed the incidence of PC after screening in relation to the number of screening rounds attended in the Finnish section of the trial. Objective To evaluate the possible reduction in PC incidence following completed screening cycles in relation to the number of screening rounds attended. Design, setting, and participants The participants in the screening arm of the Finnish screening trial (29 298 men) were divided into subgroups of men who had participated at one, two, or three screening rounds. A reference group was formed of the 43 151 men in the control arm by selecting age-matched controls for each subgroup of the screening participants. PC cases diagnosed after screening were identified from the Finnish Cancer Registry until the end of 2011. Follow-up of the screened men started 12 mo (365 d) after the last screening attendance and a similar date was assigned to the men in the control arm. Results and limitations A total of 1514 new PCs cases (cumulative incidence 5.2%) were diagnosed among the screened men after the last screening attendance. In the reference group formed from the control arm, 2683 cases (6.2%) occurred. The hazard ratio (HR) for PC among nonparticipants in the screening arm was 0.89 (95% confidence interval [CI] 0.79–0.99) compared with their controls. Among participants, the HR in those who participated once was 1.39 (95% CI 1.22–1.57), among men who participated twice the HR was 0.97 (95% CI 0.86–1.10), and among men screened three times the HR was 0.57 (95% CI 0.49–0.68). A limitation of the study was that the comparison by attendance is not based on randomization. Conclusions The postscreening PC incidence is reduced after attending three screening rounds, but not after only one or two rounds. Thus, the increased cancer detection at screening is compensated by a subsequent risk reduction only after repeated screening cycles. Patient summary The results of the study indicate that at least three prostate-specific antigen-based screening cycles are needed to reduce subsequent prostate cancer incidence. [ABSTRACT FROM AUTHOR]

Abstract: Context: Intermittent androgen deprivation (IAD) in prostate cancer (PCa) patients has been proposed to delay development of castration resistance and to reduce the side effects and costs of androgen deprivation therapy (ADT). Objective: This review analyzes (1) the oncologic and quality of life (QoL) results from randomized phase 3 trials comparing IAD and continuous ADT and (2) the prognostic parameters for IAD. Evidence acquisition: We searched the Medline and Cochrane Library databases (primary fields: prostate neoplasm and intermittent androgen deprivation; secondary fields: randomized trials, survival, quality of life, predictors) without language restriction. Evidence synthesis: We found seven extensively described phase 3 trials randomizing 4675 patients to IAD versus continuous ADT. Other randomized trials investigating IAD have been performed, but available data are limited and have been published only in preliminary fashion. In all seven trials, patients spent most of their time on, rather than off, ADT. The induction periods ranged from 3 mo to 8 mo; in all but one trial, the PSA level designated for ADT discontinuation was <4 ng/ml. Mean follow-up ranged from 40–108 mo. Collectively, these trials support the concept that, mainly in metastatic cases, IAD can produce oncologic results similar to continuous ADT. In terms of overall survival, the hazard ratios for IAD and continuous ADT were very similar (range: 0.98–1.08). The QoL benefit of IAD appears to be modest at best. With IAD, QoL is likely influenced by the duration of the off-treatment periods and by the rate of testosterone recovery. Conclusions: The evidence indicates that IAD is not inferior to continuous ADT. Data are insufficient to determine whether IAD is able to prevent the long-term complications of ADT. More comparative analysis focused on QoL is warranted. [Copyright &y& Elsevier]

Abstract: Background: Intermittent dosing may reduce the adverse events (AEs) of androgen-deprivation therapy (ADT). Objective: To compare intermittent androgen deprivation (IAD) and continuous androgen deprivation (CAD) with regard to health-related quality of life (QoL). Design, setting, and participants: A total of 852 men with advanced prostate cancer (PCa) were enrolled to receive goserelin acetate 3.6mg every 28 d for 24 wk. A total of 554 patients whose prostate-specific antigen (PSA) decreased to <10 ng/ml or by ≥50% (<20 ng/ml at baseline) were randomised to IAD or CAD. Intervention: In the IAD arm, ADT was resumed for at least 24 wk whenever PSA increased >20 ng/ml or above baseline. Outcome measurements and statistical analysis: QoL was monitored with a validated Cleary 30-item questionnaire and analysed by the Mann-Whitney U test, 0.5 standard deviation rule, and repeated measures analysis of variance. AEs and adverse drug reactions (ADRs) were analysed by the chi-square test. Results and limitations: Median follow-up was 65 mo. Significant differences in QoL emerged in activity limitation, physical capacity, and sexual functioning, favouring IAD. No significant differences emerged in the prevalence of AEs: 87 patients in the IAD arm (31.8%) and 95 in the CAD arm (33.9%) had cardiovascular (CV) AEs (p =0.59), with 25 (9.1%) and 29 (10.4%) withdrawn (p =0.62), and 21 (7.7%) and 24 (8.6%) dying because of a CV event (p =0.70), respectively; bone fractures occurred in 19 (6.9%) and 15 (5.4%) patients (p =0.44), respectively. Hot flushes or night sweats were the most common ADRs (47.1% vs 50.4%; p =0.44). Erectile dysfunction (15.7% vs 7.9%; p =0.042) and depressed mood (2.2 vs 0%; p =0.032) were more common in the IAD arm. Conclusions: IAD showed benefits in the treatment of advanced PCa with respect to QoL. The prevalence of AEs was not significantly lower with IAD. Trial registration: ClinicalTrials.gov, NCT00293670. [Copyright &y& Elsevier]

Abstract: Objectives: To quantify the bothersomeness of urinary symptoms in males with lower urinary tract symptoms (LUTS). Methods: A population-based postal survey of urinary symptoms among 2837 men aged 55, 65, or 75 years was conducted. The response rate was 75%, and data of both symptom and bother questions were eligible for 1803–2046 men, depending on the question. Bothersomeness of each urinary symptom was measured with a bother index (BI) as a ratio of the number of men with a bother score higher than a symptom score to that with a bother score lower than a symptom score. The BI was compared with the relative risk (RR), the prevalence of men with bother to those with symptom. Results: Urgency (46%) and postmicturition dribble (42%) were the most common symptoms. Any type of incontinence was considered highly bothersome (BI: 1.79–3.70). In light of the BI, most voiding and postmicturition symptoms except weak stream (BI: 1.14) were well tolerated. The variation of the BI (0.06–3.70) was substantially larger than that of RR (0.53–0.89) of the urinary symptoms. Conclusions: Bothersomeness of a symptom is an independent contribution in the assessment of LUTS. The BI may be a useful indicator of bothersomeness of urinary symptoms. The greater variation of the BI than that of RR indicates that the BI provides information on LUTS that cannot be described by prevalence or prevalence ratio only. [Copyright &y& Elsevier]