Increasing prevalence of metastatic castration-resistant prostate cancer in a managed care population in the United States.

PURPOSE: Numerous treatment breakthroughs for patients with metastatic castration-resistant prostate cancer (mCRPC) have been demonstrated in clinical trials in the past 15 years. However, real-world evidence on the changing epidemiology and longevity of this population has not been demonstrated. This study assessed prevalence trends for mCRPC over eight years in a large managed care population. METHODS: In a claims database, adult male patients were included with ≥ 1 claim for prostate cancer, pharmacologic/surgical castration, and metastatic disease during the identification period. The index mCRPC date was the first metastatic claim; six months of continuous enrollment before and after was required. Patients with metastatic disease at baseline were excluded. Patients were followed until death, end of study, or disenrollment, whichever was earliest. Total, mCRPC per-prostate cancer, and age-specific prevalence rates were calculated cross-sectionally for each year under study (2010-2017). RESULTS: Of 343,089 patients identified with a claim for prostate cancer, 3690 mCRPC cases (1.1%) were identified. Incidence (new cases per year) remained relatively constant over the study period while prevalence of mCRPC (total cases per year) increased. mCRPC prevalence increased with increasing age. Total and mCRPC per-prostate cancer prevalence rates increased in monotonic, year-over-year trends from 2010 to 2017, while incidence (new cases per year) of mCRPC remained relatively stable. CONCLUSION: This study found increasing prevalence of mCRPC in an insured patient population during the 8-year period, coupled with stable incidence, validating that patients with the disease are living longer. With the addition of androgen receptor-directed therapies and poly(ADP-ribose) polymerase inhibitors in recent years, this trend will likely continue.

Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE.

PURPOSE: Watchful waiting is an alternative to active treatment for men with low risk prostate cancer but it is unclear how health related quality of life (HRQoL) may change over time for men who select this option. We report on HRQoL in men with localized prostate cancer who selected watchful waiting. MATERIALS AND METHODS: HRQoL outcomes were reviewed for 310 men diagnosed with prostate cancer from 1990 to 2001 within Cancer of the Prostate Strategic Urological Research Endeavor who chose watchful waiting. The UCLA Prostate Cancer Index and RAND 36-Item Health Survey were completed at enrollment and approximately every 6 months. A random slopes model was developed to assess time trends in HRQoL for up to 5 years after diagnosis, adjusting for age at diagnosis and specific comorbidities. RESULTS: Significant decreases with time were observed in 7 domains of the RAND 36-Item Health Survey and 4 of the UCLA Prostate Cancer Index scales. CONCLUSIONS: Men with prostate cancer who chose watchful waiting in the current study had better or similar HRQoL outcomes compared to men without prostate cancer at the start of the study. Many of these scores were significantly affected by increasing age and decreased with time. The physical domain scores as well as sexual function scores decreased more than expected from the aging process alone.

Clinical and psychosocial characteristics of men with erectile dysfunction: baseline data from ExCEED.

INTRODUCTION: Erectile dysfunction (ED) is associated with psychological impairment, and further research is required to understand their relationship. AIM: We present descriptive baseline results from a longitudinal observational study of North American men seeking treatment for ED. METHODS: Patients completed clinical and health-related quality-of-life information at baseline and three follow-up points over 12 months; 162 patients had usable baseline data, including clinical history and current status, sociodemographic information, and standard paper-and-pencil scales of psychosocial characteristics. Scores on the International Index of Erectile Functioning erectile functioning subscale were collapsed into mild (N = 27), moderate (N = 41), or severe (N = 94) categories. Using chi-square, anova, and logistic regression, we identified baseline characteristics associated with ED severity. MAIN OUTCOME MEASURE: The main outcome measure was the degree of psychosocial impairment associated with mild, moderate, and severe ED. RESULTS: Severe ED was significantly associated with not having a regular sex partner; a history of prostate cancer; and worse scores on measures of positive affect, belonging/loneliness, sexual self-efficacy-strength, psychological adjustment, marital happiness, anxiety at last intercourse, and depression. In a multivariate logistic regression model, poorer sexual self-efficacy was most closely associated with severe ED. The model rescaled R(2) was 0.63 (area-under-the-curve, 0.91). CONCLUSIONS: Severe ED is related to impairment across a broad range of psychosocial domains, and clinicians should consider offering patients assistance in dealing with its psychosocial impact.

Longitudinal differences in psychological outcomes for men with erectile dysfunction: results from ExCEED.

INTRODUCTION: The direction of the relationship between psychological adjustment and erectile dysfunction (ED) is unclear and may differ for different men, and few studies have examined psychological outcomes for men receiving ED treatment. AIM: This study assessed the impact of ED therapy at baseline and 12-month follow-up, using standard psychological measures. METHODS: Using an observational ED registry, we collected clinical and psychosocial data at baseline and 3, 6, and 12 months. Participants had (i) a patient-reported outcomes questionnaire at baseline and at least one follow-up; and (ii) data about ED treatments received during the study. Treated men were classified as responders based on improvements in International Index of Erectile Function scores from baseline to 12 months. MAIN OUTCOME MEASURES: The main outcome measures were changes in psychological outcomes in relation to treatment status and baseline ED severity. RESULTS: Of 153 patients, 40 responded to treatment, 49 did not respond to treatment, and 64 did not receive treatment. Treatment responders reported significant improvements in 12-month sexual self-efficacy but only small improvements or no change across five other psychological domains, whereas nonresponders reported small decrements. There was a trend for differences in sexual self-efficacy to vary by baseline ED severity, as well as by treatment response. CONCLUSIONS: Diagnosing and successfully treating ED significantly affects patient psychological adjustment, so providers should actively diagnose and treat ED.

Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE.

PURPOSE: Watchful waiting is an alternative to active treatment for men with low risk prostate cancer but it is unclear how health related quality of life (HRQoL) may change over time for men who select this option. We report on HRQoL in men with localized prostate cancer who selected watchful waiting. MATERIALS AND METHODS: HRQoL outcomes were reviewed for 310 men diagnosed with prostate cancer from 1990 to 2001 within Cancer of the Prostate Strategic Urological Research Endeavor who chose watchful waiting. The UCLA Prostate Cancer Index and RAND 36-Item Health Survey were completed at enrollment and approximately every 6 months. A random slopes model was developed to assess time trends in HRQoL for up to 5 years after diagnosis, adjusting for age at diagnosis and specific comorbidities. RESULTS: Significant decreases with time were observed in 7 domains of the RAND 36-Item Health Survey and 4 of the UCLA Prostate Cancer Index scales. CONCLUSIONS: Men with prostate cancer who chose watchful waiting in the current study had better or similar HRQoL outcomes compared to men without prostate cancer at the start of the study. Many of these scores were significantly affected by increasing age and decreased with time. The physical domain scores as well as sexual function scores decreased more than expected from the aging process alone.

Increasing prevalence of gout and hyperuricemia over 10 years among older adults in a managed care population.

OBJECTIVE: To determine whether the prevalence of gout and/or clinically significant hyperuricemia increased in a managed care population over 10 years. METHODS: The study was a descriptive analysis utilizing an administrative claims database to ascertain 10-year trends in prevalence of gout and/or hyperuricemia. Prevalence rates were calculated cross-sectionally for each year (1990-99) and expressed/compared as rates per 1000 enrollees. RESULTS: The prevalence of gout and/or hyperuricemia in the overall population increased by about 2 cases per 1000 enrollees over 10 years. In the > 75 year age group, rates increased from 21 per 1000 persons in 1990 to 41 per 1000 in 1999. In the 65-74 year age group, prevalence increased from between 21 and 24 per 1000 persons in the years 1990-92 to over 31 per 1000 during the years 1997-99. Prevalence rates in younger age groups (< 65 years) stayed consistently low during the years under study. There were sex differences in most age groups, with men having the greater burden of disease at every time point. CONCLUSION: Prevalence of gout and/or hyperuricemia in the overall study population increased during the 10-year period. When stratified by age, there were increases in prevalence among groups over age 65 in both sexes. Although gout prevalence increased in both sexes over the 10-year period, men still had most of the burden of disease. In ages younger than 65, men had 4 times higher prevalence than women (4:1 ratio), but in the older age groups (> 65), the gender gap narrowed to 1 woman to every 3 men with gout and/or hyperuricemia (3:1 ratio).

Patterns of practice in the United States: insights from CaPSURE on prostate cancer management.

The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10,000 patients with prostate cancer treated at 31 primarily community-based sites across the country. The database tracks oncologic and health-related quality-of-life outcomes. Because the urologists participating in the project treat according to their usual practices, CaPSURE facilitates the study of trends in disease-management strategies, offering a reflection of "real world" practice patterns. This review highlights key studies during the past several years that document downward risk migration, validates widely used prognostic nomograms, establishes prostate-specific antigen doubling time as a surrogate endpoint for disease-specific mortality, assesses the impact of treatment on patient-reported quality of life, and presents national trends in imaging test use and primary treatment strategies for localized disease.

Longitudinal differences in disease specific quality of life in men with erectile dysfunction: results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction study.

PURPOSE: We assessed the impact of erectile dysfunction therapy on 1-year health related quality of life using a validated erectile dysfunction specific instrument. MATERIALS AND METHODS: Using an observational erectile dysfunction registry clinical, sociodemographic and health related quality of life information was collected at baseline, and 3, 6 and 12 months later. Only men who reported undergoing erectile dysfunction treatment were included in this analysis sub-sample. Patients were classified as treatment responders based on improvements in International Index of Erectile Function scores. Changes in health related quality of life scores from baseline were compared between responders and nonresponders. RESULTS: The cohort consisted of 89 patients, of whom 40 (45%) responded to therapy by International Index of Erectile Function criteria. Responders and nonresponders had comparable baseline disease severity and health related quality of life. At 1 year responders reported significantly better health related quality of life and greater improvement from baseline in sexual experience (mean change -1.64 versus 3.19) and emotional life (mean -3.01 for responders versus 1.75) domains of the Psychological Impact of Erectile Dysfunction scales (p <0.01). This 4.5 to 5 point difference in mean change score (1/2 SD) was considered moderately clinically significant. CONCLUSIONS: Men who respond to erectile dysfunction treatment report significantly better health related quality of life 1 year after initial presentation for erectile dysfunction than nonresponders. This finding should motivate providers to be more proactive in diagnosing and treating men with erectile dysfunction since successful therapy appears to improve health related quality of life. These data suggest that men in whom primary therapy for erectile dysfunction fails should be offered secondary treatment because many men in this study in whom previous therapies failed reported improved health related quality of life when they began effective secondary treatment.

Do impotent men with diabetes have more severe erectile dysfunction and worse quality of life than the general population of impotent patients? Results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction (ExCEED) database.

OBJECTIVE: Little is known regarding how diabetic men with erectile dysfunction (ED) differ from the general population of impotent men. The primary objective of this study was to compare disease-specific health-related quality of life (HRQOL) and severity of ED in impotent men with and without diabetes. RESEARCH DESIGN AND METHODS: Validated functional and HRQOL questionnaires (including the International Index of Erectile Function, the Sexual Self-Efficacy Scale, and the Psychological Impact of Erectile Dysfunction scales) were administered to patients in an ED disease registry. Men with ED and a history of diabetes (n = 20) were compared with men with ED and no history of diabetes (n = 90) at baseline and at the 12-month follow-up. RESULTS: Diabetic impotent men reported worse erectile function and intercourse satisfaction at baseline, and ED had a greater impact on their emotional life. Diabetic men with ED had significantly different trends over time in the Erectile Function (P < 0.001), Intercourse Satisfaction (P < 0.013), Sexual Desire (P < 0.016), Overall Satisfaction (P < 0.023), and the Sexual Experience-Psychological Impact domains (P < 0.002). In addition, there was a trend toward a difference over time in the Emotional Life-Psychological Impact domain (P < 0.067). CONCLUSIONS: Impotent men with diabetes present with worse ED than nondiabetic men with ED, resulting in worse disease-specific HRQOL in the diabetic men. Although diabetic patients initially respond well to ED treatment, responses do not appear to be durable over time. Therefore, clinicians must provide longer-term follow-up when treating ED in diabetic patients.