Search

The association between androgen deprivation therapy (ADT) and dementia in men with prostate cancer remains inconclusive. We assessed the association between cumulative ADT exposure and the onset of dementia in a nationwide longitudinal registry of men with prostate cancer.A retrospective analysis of men aged ≥50 years from the CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) registry was performed. The primary outcome was onset of dementia after primary treatment. ADT exposure was expressed as a time-varying independent variable of total ADT exposure. The probability of receiving ADT was estimated using a propensity score. Cox proportional hazards regression was performed to determine the association between ADT exposure and dementia with competing risk of death, adjusted for propensity score and clinical covariates among men receiving various treatments.Of 13,570 men 317 (2.3%) were diagnosed with dementia after a median of 7.0 years (IQR 3.0-12.0) of followup. Cumulative ADT use was significantly associated with dementia (HR 2.02; 95% CI 1.40-2.91; p0.01) after adjustment. In a subset of 8,506 men, where propensity score matched by whether or not they received ADT, there was also an association between ADT use and dementia (HR 1.59; 95% CI 1.03-2.44; p=0.04). There was no association between primary treatment type and onset of dementia in the 8,489 men in the cohort who did not receive ADT.Cumulative ADT exposure was associated with dementia. This increased risk should be accompanied by a careful discussion of the needs and benefits of ADT in those being considered for treatment.

INTRODUCTION AND OBJECTIVE:Radiotherapy (RT) for prostate cancer are associated with distinct treatment-related morbidity, primarily in domains of urinary and bowel health-related quality of life (...

INTRODUCTION AND OBJECTIVE:Radiotherapy (RT) for prostate cancer is associated with a distinct constellation of treatment-related complications and morbidities. However, few studies have reported t...

Background Diet and exercise may be associated with quality of life and survival in men with prostate cancer. Objective This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. Methods We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls—one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. Results In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. Conclusions A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. Trial Registration ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013

PurposePost-diagnostic coffee and tea consumption and prostate cancer progression is understudied.MethodsWe examined 1,557 men from the Cancer of the Prostate Strategic Urologic Research Endeavor who completed a food frequency questionnaire a median of 28months post-diagnosis. We estimated associations between post-diagnostic coffee (total, caffeinated, decaffeinated) and tea (total, non-herbal, herbal) and risk of prostate cancer progression (recurrence, secondary treatment, bone metastases, or prostate cancer death) using Cox proportional hazards regression. We also examined whether smoking (current, former, never) modified these associations.ResultsWe observed 167 progression events (median follow-up 9years). Higher coffee intake was associated with higher risk of progression among current smokers (n = 95). The hazard ratio (HR) [95% confidence interval (CI)] for 5 vs 0 cups/day of coffee was 0.5 (CI 0.2, 1.7) among never smokers, but 4.5 (CI 1.1, 19.4) among current smokers (p-interaction: 0.001). There was no association between total coffee intake and prostate cancer progression among never and former smokers. However, we observed an inverse association between decaffeinated coffee (cups/days) and risk of prostate cancer progression in these men (HR > 0 to

INTRODUCTION AND OBJECTIVE:Recent studies have suggested an association between androgen deprivation therapy (ADT) and an increased risk of Alzheimer’s disease and/or dementia (ADD) in men with pro...

BACKGROUND/OBJECTIVES: Older adults undergoing surgery face potential outcomes that can adversely impact their quality of life. For this reason, advance care planning (ACP) is a recommended component of preoperative care. An emerging opportunity to incorporate ACP is through preoperative optimization programs. This report details an innovative model of care, the Surgery Wellness Program (SWP), which utilizes a multidisciplinary team to develop and implement preoperative care plans for older adults and describes its impact on ACP engagement. DESIGN: Retrospective analysis of a clinical demonstration project. SETTING: A preoperative optimization program for older adults undergoing surgery at a 796-bed academic tertiary hospital. PARTICIPANTS: Older adults (N=131) who participated in the SWP from February 2015 to August 2017. INTERVENTION: All SWP patients met with a geriatrician who engaged them in a semi-structure ACP discussion. Trained medical and nurse practitioner students were used as health coaches who contact patients regularly to address and document ACP. MEASUREMENTS: Patient self-report of ACP engagement before and after participation in the SWP was determined with SWP geriatrician and health coach progress notes. Medical records were assessed for the presence of scanned documentation. Feasibility data on the number of health coach calls was collected. RESULTS: After completion of the program, the proportion of patients with a designated surrogate increased from 67% to 78% (p

Background: The association of obesity at diagnosis with prostate cancer progression is uncertain. This study aimed to examine the relationship between body mass index (BMI; 18.5– Methods: We examined men enrolled in CaPSURE who underwent radical prostatectomy between 1995 and 2017. Multiple imputation methods were used to handle missing data and reported along with complete case findings. Results: Participants (n = 5,200) were followed for a median of 4.5 years; 685 experienced recurrence. Obesity was associated with higher prognostic risk at time of diagnosis (ORobese = 1.5; ORvery obese = 1.7) and upward reclassification of disease between biopsy and surgery, driven by change in tumor stage (ORobese = 1.3; ORvery obese = 1.6). We observed an association between BMI and recurrence with adjustment for disease severity using diagnostic factors (HRvery obese = 1.7); this association disappeared when adjusting for disease severity factors obtained at surgery. Conclusions: Our findings suggest that residual confounding may partially explain the conflicting evidence regarding obesity's influence on prostate cancer progression. Assessing T-stage via digital rectal exam may be complicated in larger men, potentially affecting clinical treatment decisions. A strong association with all-cause mortality demonstrates healthier BMI at diagnosis may still improve overall survival. Impact: Patients with greater BMI are prone to more advanced disease at diagnosis and may be more likely to have their tumor stage underestimated at diagnosis.

Objectives Development and pilot evaluation of a personalized decision support intervention to help men with early‐stage prostate cancer choose among active surveillance, surgery, and radiation. Methods We developed a decision aid featuring long‐term survival and side effects data, based on focus group input and stakeholder endorsement. We trained premedical students to administer the intervention to newly diagnosed men with low‐risk prostate cancer seen at the University of California, San Francisco. Before the intervention, and after the consultation with a urologist, we administered the Decision Quality Instrument for Prostate Cancer (DQI‐PC). We hypothesized increases in two knowledge items from the DQI‐PC: How many men diagnosed with early‐stage prostate cancer will eventually die of prostate cancer? How much would waiting 3 months to make a treatment decision affect chances of survival? Correct answers were: “Most will die of something else” and “A little or not at all.” Results The development phase involved 6 patients, 1 family member, 2 physicians, and 5 other health care providers. In our pilot test, 57 men consented, and 44 received the decision support intervention and completed knowledge surveys at both timepoints. Regarding the two knowledge items of interest, before the intervention, 35/56 (63%) answered both correctly, compared to 36/44 (82%) after the medical consultation (P = .04 by chi‐square test). Conclusions The intervention was associated with increased patient knowledge. Data from this pilot have guided the development of a larger scale randomized clinical trial to improve decision quality in men with prostate cancer being treated in community settings., Men with low‐risk prostate cancer are at risk for making decisions based on misconceptions about treatment options and outcomes. A decision support intervention, delivered by premedical students acting as health coaches, increased patient knowledge of key facts about prognosis.

We explored the prevalence and trends of self-reported complementary and alternative medicine use among patients with prostate cancer using CaPSURE™ (Cancer of the Prostate Strategic Urologic Research Endeavor).A total of 7,989 CaPSURE participants completed questionnaires between 1996 and 2016 on the use of nearly 70 complementary and alternative medicine types. Participants were defined as users if they indicated that they had ever used complementary and alternative medicines. To evaluate trends among 7,696 patients with newly diagnosed prostate cancer we considered complementary and alternative medicine use within 24 months of diagnosis and calculated the percent change in complementary and alternative medicine use between groups defined by the year of diagnosis.Of patients with prostate cancer 56% reported complementary and alternative medicine use on at least 1 questionnaire. Multivitamin and omega-3 fatty acid use was common at 40% and 24% of patients, respectively. Compared to nonusers greater proportions of complementary and alternative medicine users were college educated, had a higher household income and lived in the West and Midwest. Median prostate specific antigen at diagnosis was 5.8 (IQR 4.4-8.4) and 6.2 ng/ml (IQR 4.7-10.1) among users and nonusers, respectively (p0.01). Between those diagnosed in 1996 to 2000 and 2011 to 2016, complementary and alternative medicine use increased 128% from 24% to 54%. When comparing participants diagnosed in 2006 to 2010 with those diagnosed in 2011 to 2016, a 108% increase was seen in supplemental vitamin D use and a -48% decrease was seen in supplemental vitamin E use.Many patients with prostate cancer reported complementary and alternative medicine use. Multivitamins and omega-3 fatty acids were commonly ingested and vitamin D use increased dramatically from 2006 to 2010 compared to 2011 to 2016. These data can guide clinical discussions and decision making such as nutritionist referral and help prioritize future research.

INTRODUCTION AND OBJECTIVES:We provide updated comparative effectiveness based on long-term, 18-year prostate cancer-specific mortality (PCSM) among men who underwent radical prostatectomy (RP), me...

INTRODUCTION AND OBJECTIVES:Complementary and alternative medicine (CAM) use is common among prostate cancer (PCa) patients. The benefits and risks of the majority of CAM are inconclusive, and thus...

INTRODUCTION AND OBJECTIVES:Evidence regarding the use of adjuvant therapy for patients with adverse features at radical prostatectomy (RP) has evolved over the years. The aims of this study were t...

OBJECTIVE To determine trends and predictors of adjuvant therapy in patients with adverse features at radical prostatectomy (RP), and to investigate the associations of adjuvant therapy and adverse feature type with survival. METHODS From the Cancer of the Prostate Strategic Urologic Research Endeavor registry (1990-2017), 2209 men with adverse features (pT3N0M0 disease and/or positive surgical margins), and 108 men with positive lymph nodes (pN1) at RP were identified. Temporal trends were evaluated, and predictors of adjuvant therapy were assessed with multivariate logistic regression. Kaplan-Meier analysis and competing risks regression were used to test cumulative incidence and risk of all-cause and prostate cancer-specific mortality. RESULTS Of 2209 men with adverse features and pN0 disease, 89 (4.0%), 82 (3.7%), and 30 (1.4%) received adjuvant external beam radiation therapy (ERBT) alone, androgen deprivation therapy (ADT) alone, or combined EBRT and ADT, respectively. Of 108 men with pN1 disease, 54 (50%) received ADT with or without EBRT. Adjuvant treatment for patients with adverse features decreased from 13.3% (1990-1994) to 6% or less (2005-2017, Ptrend CONCLUSION Adjuvant therapy declined for men with adverse features at RP. Providers do not treat all adverse feature types the same way, despite broad treatment recommendations in guidelines.

Background New data is emerging to guide initial treatment of patients with metastatic prostate cancer (CaP). This study utilizes the Cancer of the Prostate Strategic Urologic Research Endeavor registry to evaluate variations in survival based on initial treatment received by men with metastatic disease at diagnosis or after progression. Materials and methods Cancer of the Prostate Strategic Urologic Research Endeavor is a national registry of men diagnosed with CaP and managed at 43 community, academic, and Veteran's centers. We examined socio-demographic factors, disease biology, initial and subsequent therapy received, and survival among patients who presented with de novo or recurrent metastatic disease stratified by receipt of initial local therapy vs. combined local and hormonal therapy. The outcome was prostate cancer specific mortality (PCSM). We performed Fine and Gray competing risks regression analysis to evaluate the association between timing of metastasis and PCSM, adjusted for age, initial treatment, and subsequent therapy. Results Of the 14,753 patients diagnosed with CaP from 1990 to 2016, 669 (5%) had metastatic disease. Among the examined patients, 303 (45%) had metastatic disease at diagnosis and 366 (55%) progressed to metastatic disease. Overall, 461 (69%) were ≥65 years old, 582 (87%) had Medicare, and 227 (34%) had an annual income 20 ng/ml for 342 (51%) patients and biopsy Gleason grade was ≥4 + 3 for 386 (58%) patients. Among patients with metastatic disease at diagnosis, 31 (10%) received initial local therapy and 272 (90%) received initial hormonal therapy. Among patients who progressed to metastatic disease, 239 (65%) received initial local therapy and 127 (35%) received initial systemic hormonal therapy. Among patients with metastatic disease, the multivariate competing risks model, after adjusting for sociodemographics, marital status, diagnosis year, and comorbidities, revealed a significantly lower risk of PCSM among patients with de novo vs. recurrent metastatic disease (Hazard Ratio 0.66 (95% Confidence Interval 0.51, 0.85) P = 0.002). In the stratified analysis, no difference was seen for patients treated with initial hormonal vs. combined local and hormonal therapy. Conclusions In this analysis of a nationwide cohort of men treated for CaP with all types of therapy over 25 years, we observed that among men with metastatic CaP, the risk of PCSM was lower for de novo vs. recurrent metastatic disease. Additionally, no difference was observed based on initial treatment with combined local and hormonal therapy vs. hormonal therapy alone.

Objectives Valued life activities are those activities an individual deems particularly important or meaningful. Surgery in older adults can affect their ability to perform valued activities, but data are lacking. We characterized these activities and assessed performance of them following surgery. Design Retrospective observational study. Setting Preoperative program for older adults undergoing elective surgery at an academic hospital. Participants Older adults (N = 194) in the program from February 2015 to February 2018. Measurements A preoperative written questionnaire asked, "What are the activities that are most important to you to be able to do when you return home from surgery?" Participants could list up to three activities. Content analysis was used to develop domains of valued life activities and categorize responses. Postoperative questionnaires and medical records were used to determine ability to perform activities 6 months after surgery. Results Of 194 participants (mean age = 74.9 ± 9.1 y), 57.7% were female; 33.5% had more than two comorbid conditions. We elicited 510 valued activities, with a mean of 2.6 (± .7) activities per participant. Content analysis revealed five categories: (1) recreational activities (28.9%); (2) mobility (24.9%); (3) activities of daily living (ADLs; 17.5%); (4) instrumental activities of daily living (IADLs; 16.9%); and (5) social activities (12.0%). Ultimately, 154 participants had surgery, of which 27.3% were unable to perform one of their valued activities at 6 months. Performance varied between activity categories; 91.9% of mobility activities, 90.8% of ADLs, 80.3% of IADLs, 77.3% of social activities, and 65.5% of recreational activities were able to be performed after surgery. Conclusion Older adults expressed a wide range of valued life activities. More than one-quarter were unable to engage in at least one valued life activity after surgery, with recreation the most commonly affected. Assessment of valued life activities should be incorporated into the perioperative management of older adults. J Am Geriatr Soc 67:2305-2310, 2019.

Androgen deprivation therapy (ADT) has been shown to improve survival for men with intermediate and high-risk prostate cancer undergoing external-beam radiation therapy (EBRT). Using data from a community-based prospective disease registry, we investigated usage of EBRT with or without neoadjuvant ADT. The CaPSURE database contains 14,863 men with prostate cancer, including 1337 men diagnosed between 1990 and 2014 with localized disease who received EBRT as primary treatment. Prostate cancer risk was calculated using the CAPRA score. Patient characteristics were compared using the Mantel–Haenszel chi-square test for trend and analysis of variance. Between 1990 and 2014, 14,010 men were diagnosed with localized disease within the CaPSURE registry. Of those, 1337 underwent EBRT. Patients had a median age of 71 years. The use of ADT in addition to EBRT increased from 24% in 1990 to 60% in 1996 with a decrease seen to 47% in 2011. Men receiving ADT have differing clinical characteristics including higher PSA at diagnosis, higher Gleason grade, and higher CAPRA scores. Median ADT duration was 4 months. The use of ADT in conjunction with primary EBRT has increased in frequency and duration since 1990. Men receiving ADT have higher risk characteristics than those receiving EBRT alone. There is substantial variability in use of ADT in clinical practice.

PurposeComparing patient reported outcomes such as urinary and erectile function across institutions is critical for prostate cancer research and quality assurance. Such comparisons are complicated due to the use of different questionnaires. We aimed to develop a method to convert scores among 4 commonly used instruments.Materials and methodsPatient reported data on urinary and sexual function were collected on 1,284 men with localized prostate cancer using the EPIC-26 (Expanded Prostate Index Composite), PCI (UCLA Prostate Cancer Index), SHIM (Sexual Health Inventory for Men) and I-PSS (International Prostate Symptom Scale) questionnaires. We investigated several methods to convert scores among questionnaires.ResultsConversion between EPIC and PCI urinary and sexual function subscales was best achieved using only the subset of questions asked on both questionnaires. For the conversion between EPIC or PCI erectile function scores and SHIM scores, we defined thresholds of poor, intermediate and good function as EPIC/PCI 0 to 40 and SHIM 1 to 7, EPIC/PCI 41 to 59 and SHIM 8 to 16, and EPIC/PCI 60 to 100 and SHIM 17 to 25, respectively. Urinary continence scores highly correlated for PCI and EPIC (r = 0.94). No comparison was possible for I-PSS with EPIC and PCI due to differences in the domains addressed by these questionnaires.ConclusionsWe have introduced methods to convert scores among the EPIC, PCI and SHIM questionnaires. While these conversion methods may introduce minor imprecision, to our knowledge they represent the best available tools to combine and compare patient reported outcomes that are assessed using different instruments in men undergoing radical prostatectomy or active surveillance.

Introduction Randomized clinical trials are considered the gold standard for evidence-based practices but strict inclusion and exclusion criteria, costs to perform them and the time required to design and complete them may limit generalizability, followup and timeliness. Observational studies based on well designed, large volume patient registries may be more flexible in that scope. Such registries can be modified with time to incorporate new treatments as they emerge. Methods We describe the design, objectives, funding mechanisms and results to date of the major prostate cancer registries in the United States, highlighting as examples PCOS, CaPSURE™, PROST-QA, CEASAR, MUSIC and AQUA. Results Registries and collaborations have provided valuable knowledge for prostate cancer regarding oncologic and health related quality of life outcomes among treatments, changes in disease prevalence, staging, national practice trends and health service utilization. Conclusions While there are important limitations to observational data, registries will continue to have an important and growing role in advancing prostate cancer care as a complement to data from clinical trials and traditional cohort studies.

92 Background: Complementary and alternative medicine (CAM) use is common among prostate cancer (PCa) patients. The benefits and risks of the majority of CAM is inconclusive, and thus understanding trends in use is necessary to guide future research. We sought to investigate the prevalence of CAM use and trends in newly diagnosed PCa patients using the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE). Methods: Between 1996-2017, 7,989 CaPSURE subjects completed questionnaires on use of over 50 CAM types. For prevalence, subjects were identified as users if they ever indicated CAM use. We then performed univariate analyses to examine associations between sociodemographic and clinical characteristics with CAM use using chi-squared tests. To observe trends in CAM use among newly diagnosed patients, we limited subject responses to questionnaires completed within 24 months of diagnosis (7,358 subjects). We then grouped subjects by diagnosis year and calculated percent change in use. Results: Overall, 56% of subjects reported any CAM use. Commonly used CAM were multivitamins (40% of participants) and essential fatty acids and omega-3 (24% of participants). Compared to non-CAM users, a greater proportion of CAM users were college-educated, had a higher household income, and lived in the West and Midwest regions of the U.S (all p < 0.01). In exploring trends, we found that overall CAM use increased by +203% (19% to 56%) between those diagnosed in 1996-1999 and 2010-2017. Between those diagnosed in 2005-2009 and 2010-2017, the largest changes in use were seen in acupuncture (+289%), Vitamin D (+204%), selenium (-59%), and vitamin E (-39%). Conclusions: PCa patients reported widespread CAM use in 1996-2017. Multivitamins were the most prevalent CAM, and use of acupuncture and Vitamin D increased dramatically. This information may help to prioritize research needs and reinforces the importance of discussing CAM use with patients, with referral to specialists (e.g., nutritionists) when indicated.

Background: Processed meat and fish have been shown to be associated with the risk of advanced prostate cancer, but few studies have examined diet after prostate cancer diagnosis and risk of its progression. Objective: We examined the association between postdiagnostic consumption of processed and unprocessed red meat, fish, poultry, and eggs and the risk of prostate cancer recurrence or progression. Design: We conducted a prospective study in 1294 men with prostate cancer, without recurrence or progression as of 2004‐2005, who were participating in the Cancer of the Prostate Strategic Urologic Research Endeavor and who were followed for an average of 2 y. Results: We observed 127 events (prostate cancer death or metastases, elevated prostate-specific antigen concentration, or secondary treatment) during 2610 person-years. Intakes of processed and unprocessed red meat, fish, total poultry, and skinless poultry were not associated with prostate cancer recurrence or progression. Greater consumption of eggs and poultry with skin was associated with 2fold increases in risk in a comparison of extreme quantiles: eggs [hazard ratio (HR): 2.02; 95% CI: 1.10, 3.72; P for trend = 0.05] and poultry with skin (HR: 2.26; 95% CI: 1.36, 3.76; P for trend = 0.003). An interaction was observed between prognostic risk at diagnosis and poultry. Men with high prognostic risk and a high poultry intake had a 4-fold increased risk of recurrence or progression compared with men with low/intermediate prognostic risk and a low poultry intake (P for interaction = 0.003). Conclusions: Our results suggest that the postdiagnostic consumption of processed or unprocessed red meat, fish, or skinless poultry is not associated with prostate cancer recurrence or progression, whereas consumption of eggs and poultry with skin may increase the risk. Am J Clin Nutr 2010;91:712‐21.

132 Background: We evaluated the feasibility and efficacy of a decision support intervention designed to help men with low-risk prostate cancer consider active surveillance and standard treatments. The intervention incorporated a decision aid with coaching and question-listing. Our decision aid is the first to include data on long-term survival and side effects from men with prostate cancer undergoing active surveillance, surgery, and radiation. Methods: To develop the intervention, we conducted focus groups using the Nominal Group Technique. We used a survey instrument from the International Patient Decision Aids Standards to measure the stakeholder endorsement of our intervention. To test the intervention, we administered it to newly diagnosed men with low-risk prostate cancer (Gleason sum < = 3+4, stage < = T2N0M0, PSA < = 10 ng/ml) seen at UCSF. Before and after the intervention, we administered a survey with questions from the Decision Quality Instrument for Prostate Cancer. Our primary outcome was change in knowledge as assessed by two multiple-choice items: How many men diagnosed with early stage prostate cancer will eventually die of prostate cancer? How much would waiting 3 months to make a treatment decision affect chances of survival? Correct answers were: “Most will die of something else” and “A little or not at all.” Results: The development phase involved 6 patients, 1 family member, 2 physicians, and 5 other health care providers and four iterations of the intervention until consensus endorsement was reached. In the pilot test, 57 men consented, and 44 received the decision support intervention and completed surveys at both timepoints. Before the intervention, 30/44 (68%) got both questions right, compared to 36/44 (82%) after the intervention. 82% maintained or achieved perfect scores; 16% answered 1 or more incorrectly both before and after the intervention; and 2% answered both items correctly before, but 1 wrong after. Conclusions: This novel decision support intervention was feasible, and appeared to improve knowledge and informed decision-making. Data will guide the development of a larger scale randomized clinical trial to improve decision quality in men with prostate cancer, in the community. Clinical trial information: NCT02451345.

BACKGROUND. Among the most pressing challenges that face physicians who care for men with prostate cancer is evaluating the patient's potential for benefiting from treatment. Because prostate cancer often follows an indolent course, the presence and severity of comorbidities may influence the decision to treat the patient aggressively. The authors adapted the Total Illness Burden Index (TIBI) for use in decision-making among men with prostate cancer at the time of the visit. METHODS. An observational study was performed of 2894 participants in the Cancer of the Prostate Strategic Urologic Research Endeavor, a national disease registry of men with prostate cancer, to examine how well the adapted TIBI for prostate cancer (TIBI-CaP) predicted mortality over the subsequent 3.5 years and health-related quality of life over the subsequent 6 months. RESULTS. The men who had the highest global TIBI-CaP scores were 13 times more likely to die of causes other than prostate cancer over a 3.5-year period than the men who had the lowest scores (hazard ratio, 13.1, 95% confidence interval, 6.3–27.4) after controlling for age, education, income, and race/ethnicity. Patients who had the highest TIBI-CaP scores had 44% mortality compared with 4.9% mortality for patients who had the lowest scores. Demographic variables explained 16% of the variance in future physical function; TIBI-CaP scores explained an additional 19% of the variance. CONCLUSIONS. The TIBI-CaP, a patient-reported measure of comorbidity, identified patients at high risk for nonprostate cancer mortality. It predicted both mortality and future quality of life. The TIBI-CaP may aid physicians and patients in making appropriate treatment decisions. Cancer 2007. © 2007 American Cancer Society.

Objectives To assess specific complementary and alternative medicine (CAM) use in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a large, community-based national registry of men with prostate cancer. Methods We examined more than 50 types of CAM use in a large, national, community-based registry of men with prostate cancer (CaPSURE). Participants completed biannual surveys within 2 years of diagnosis and treatment. We analyzed associations of CAM use with sociodemographic and clinical features, using chi-square tests and multivariate logistic regression. Results One third of 2582 respondents reported using CAM. Common practices included vitamin and mineral supplements (26%), herbs (16%), antioxidants (13%), and CAM for prostate health (12%; eg, saw palmetto, selenium, vitamin E, lycopene). In multivariate analyses, users were more likely to have other comorbid conditions, worse cancer grade at diagnosis, higher incomes, more education, and to live in the West. Conclusions Complementary and alternative medicine use was associated with sociodemographic and clinical characteristics in this large sample of men with prostate cancer. These results should be considered by health care professionals counseling men with prostate cancer regarding diet and secondary prevention.

Summary Background The aim of this study was to assess the probability of low-grade squamous intra-epithelial lesion (LSIL) regression in young women, and to examine the factors associated with this regression. Methods In a longitudinal study of human papilloma virus (HPV) infection, female adolescents aged 13–22 years were examined every 4 months by cytology, colposcopy, and HPV DNA status. Both prevalent and incident LSIL cases were included in the analysis, with regression defined as at least three consecutive normal Pap smears. Findings Median follow-up time from baseline (defined as the time of first LSIL diagnosis) for the 187 women with LSIL was 61 months (IQR 34–80). Median time they had been sexually active at diagnosis was 3·2 years (2·6–6·5). Probability of regression for the entire cohort was 61% (95% CI 53–70) at 12 months and 91% (84–99) at 36 months of follow-up. No associations were found between LSIL regression and HPV status at baseline, sexual behaviour, contraceptive use, substance or cigarette use, incident sexually transmitted infection, or biopsy. Multivariate analysis showed that only HPV status at the current visit was associated with rate of regression, whether infection was caused by one or more viral types (relative hazard=0·3 [95% CI 0·21–0·42], and 0·14 [0·08–0·25], respectively). Interpretation The high rate of regression recorded in this study lends support to observation by cytology in the management of LSIL in female adolescents. Negative HPV status was associated with regression, suggesting that HPV testing could be helpful in monitoring LSIL.

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.

Purpose: Secondary cancer treatment is common after definitive local therapy for prostate cancer and it may be an indicator of the efficacy and cost of primary local treatment. We determined predictors of secondary cancer treatment in patients initially treated with radical prostatectomy or external beam radiation.Materials and Methods: We examined 2,336 patients in Cancer of the Prostate Strategic Urologic Research Endeavor, a longitudinal registry of patients with prostate cancer, who underwent initial treatment with radical prostatectomy (1,744) or external beam radiation (592). Patients had at least 1 month of followup and all pretreatment information was available. The percent of patients receiving secondary cancer treatment, time to secondary treatment and type of secondary treatment delivered was determined. Multivariate analysis was done to determine independent predictors of secondary cancer treatment. In patients initially treated with prostatectomy a similar analysis was performed to identify p...

The follow-up results of a 9-month observational study of 150 onychomycosis patients treated with a variety of mechanical, topical, and oral therapies by podiatric physicians and dermatologists are presented. Changes from baseline in toenail condition and patient satisfaction were assessed at 4- and 9-month follow-up. At 9 months, patients who had received oral therapy reported significantly fewer onychomycosis-related problems in social situations, including embarrassment or self-consciousness about the appearance of nails, avoidance of contact by others, being perceived as unclean or untidy, and the desire to keep their nails concealed. Patient-reported satisfaction with the treatment program was significantly higher for those receiving oral therapy than for those receiving nonoral therapy. (J Am Podiatr Med Assoc 91(10): 521-527, 2001)

Purpose: We determined the demographic and clinical profile of men who elect surveillance as the initial management of prostate cancer as well as the incidence and predictors of secondary treatment of these patients.Materials and Methods: The Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE) is a national disease registry of patients with various stages and treatments of prostate cancer. Using this database of 4,458 men we identified 329 (8.2%) who elected surveillance as the initial management of prostate cancer. Patients choosing watchful waiting were compared to other CaPSURE participants using the chi-square test. The likelihood of treatment initiation in the watchful waiting group was calculated using the Kaplan-Meier method. After adjusting for patient age, race, prostate specific antigen (PSA) at diagnosis, clinical T stage and total Gleason score the Cox proportional hazards regression model was used to determine significant predictors of treatment initiation.Results: Compare...

Purpose:: We determined the impact of positive surgical margins on prostate specific antigen (PSA) recurrence and secondary treatment in patients who underwent radical prostatectomy as definitive local treatment for prostate cancer.Materials and Methods:: We reviewed the pathology reports of 1,383 patients in the CaPSURE * *Technology Assessment Group, San Francisco, California. database, a longitudinal disease registry of men with prostate cancer, who underwent radical prostatectomy as definitive local treatment. Pathological stage, Gleason score, and the number and location of any positive surgical margins were determined in each patient. PSA recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after radical prostatectomy. Secondary cancer treatment consisted of radiation or androgen deprivation after radical prostatectomy. Adjuvant and nonadjuvant secondary treatment was given within and more than 6 months after radical prostatectomy, respectively. Kaplan-Meier event rates of...

To evaluate the effects of mode, order of administration, and the interaction of mode and order on health-related quality of life scales when self-administered by mixed mode (paper-mode and web-mode) for measurement equivalence. Health-related quality of life data was analyzed from the Cancer of the Prostate Strategic Urologic Research Endeavor using the Medical Outcomes Study (MOS) Short Form-36 (SF-36) and the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). A randomized crossover design assigned participants to two groups with a preferred 2–5-day washout period. Cognitive debriefing evaluated participants’ mode preference. Of the 245 men enrolled, 85 % completed both modes. The majority were White (97 %), college educated (66 %), reported an annual income >$75,000 (46 %), and a median age of 69 years. Intraclass correlation coefficients were high for each item on both instruments (r = .54–.97). Exact percentage agreement for yes/no items was high (≥.88). For the SF-36, significant differences were observed for order of administration (physical component and physical function scores) and for the interaction between mode and order (mental component, role emotional, social function, vitality, and mental health scores). For the UCLA-PCI, the largest difference was 12.8 points lower for sexual bother for order of administration by web-mode first (p = .03). Seventy percent preferred the web-mode, 21 % had no preference, and 9 % preferred the paper-mode. Web-mode and paper-mode administrations of the SF-36 and UCLA-PCI are equivalent in men with prostate cancer, implying that mixed-mode survey administration is warranted.

Purpose: To examine differences in the beliefs and behaviors of female adolescents at varying degrees of probable risk for HIV transmission. Methods: A clinically-based, ethnically diverse sample of 696 sexually active female adolescents was recruited from urban and suburban general adolescent, family planning, and public health clinics. Subjects were categorized into four risk status groups on the basis of their history of IV drug use, sexually transmitted disease (STD), and probable risk of contact with an infected individual (living in a high-risk geographic location, sexual promiscuity, sex with male homo/bisexuals). Results: Females in the highest risk group showed high rates of substance use, anal intercourse, and intentions to have future risky sexual partners. A second high-risk group reported high rates of STDs, inconsistent condom use, and less AIDS knowledge. Conclusion: Different subsets of higher risk adolescents may require different intervention strategies.

This study was performed to identify specific high-risk behaviors, such as unprotected oral, anal, and vaginal intercourse and substance abuse, associated with human immunodeficiency virus infection among adolescents attending three diverse clinics located in a localized geographic area: a university-based clinic, a Planned Parenthood clinic, and an inner-city public health clinic (PHC). Six hundred seventy-one female and 207 male adolescents attending one of the three clinics completed a structured questionnaire. Similarities among patients at the clinic sites included high rates of anal intercourse (21%), unprotected vaginal sex (95%), oral sex (73%), and poor communication skills (42%). Some differences appeared as well, including higher rates of homosexual experiences, no birth control use, and having multiple partners among adolescents attending the PHC (p0.001). In contrast, adolescents attending either the university-based clinic or the Planned Parenthood Clinic had higher rates of substance abuse around sexual activity than those who attended the PHC (p0.001). We conclude that adolescents attending general medical clinics in the San Francisco Bay area engage in high-risk behaviors that place them at risk for transmission of human immunodeficiency virus even though many have had previous education about acquired immunodeficiency syndrome and sexually transmitted disease. Specific risk factors include unprotected receptive anal intercourse, unprotected vaginal intercourse with new and unknown partners, experience in homosexual behavior, high rates of oral sex, multiple partners, poor communication skills, and frequent use of illicit substances in conjunction with sex. The differences found among sites indicate the need for health care providers and prevention programs to provide emphasis on practices specific to the adolescents in their service area.

Because no adequate randomized trials have compared active treatment modalities for localized prostate cancer, the authors analyzed risk-adjusted, cancer-specific mortality outcomes among men who underwent radical prostatectomy, men who received external-beam radiation therapy, and men who received primary androgen-deprivation therapy.The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry comprises men from 40 urologic practice sites who are followed prospectively under uniform protocols, regardless of treatment. In the current study, 7538 men with localized disease were analyzed. Prostate cancer risk was assessed using the Kattan preoperative nomogram and the Cancer of the Prostate Risk Assessment (CAPRA) score, both well validated instruments that are calculated from clinical data at the time of diagnosis. A parametric survival model was constructed to compare outcomes across treatments adjusting for risk and age.In total, 266 men died of prostate cancer during follow-up. Adjusting for age and risk, the hazard ratio for cancer-specific mortality relative to prostatectomy was 2.21 (95% confidence interval [CI], 1.50-3.24) for radiation therapy and 3.22 (95% CI, 2.16-4.81) for androgen deprivation. Absolute differences between prostatectomy and radiation therapy were small for men at low risk but increased substantially for men at intermediate and high risk. These results were robust to a variety of different analytic techniques, including competing risks regression analysis, adjustment by CAPRA score rather than Kattan score, and examination of overall survival as the endpoint.Prostatectomy for localized prostate cancer was associated with a significant and substantial reduction in mortality relative to radiation therapy and androgen-deprivation monotherapy. Although this was not a randomized study, given the multiple adjustments and sensitivity analyses, it is unlikely that unmeasured confounding would account for the large observed differences in survival.

Purpose Prostate cancer epidemiology has been marked overall by a downward risk migration over time. However, in some populations, both in the United States and abroad, many men are still diagnosed with high-risk and/or advanced disease. Primary androgen deprivation therapy (PADT) is frequently offered to these patients, and disease risk prediction is not well-established in this context. We compared risk features between large disease registries from the United States and Japan, and aimed to build and validate a risk prediction model applicable to PADT patients. Methods Data were analyzed from 13,740 men in the United States community-based Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry and 19,265 men in the Japan Study Group of Prostate Cancer (J-CaP) database, a national Japanese registry of men receiving androgen deprivation therapy. Risk distribution was compared between the two datasets using three well-described multivariable instruments. A novel instrument (Japan Cancer of the Prostate Risk Assessment [J-CAPRA]) was designed and validated to be specifically applicable to PADT patients, and more relevant to high-risk patients than existing instruments. Results J-CaP patients are more likely than CaPSURE patients to be diagnosed with high-risk features; 43% of J-CaP versus 5% of CaPSURE patients had locally advanced or metastatic disease that could not be stratified with the standard risk assessment tools. J-CAPRA—scored 0 to 12 based on Gleason score, prostate-specific antigen level, and clinical stage—predicts progression-free survival among PADT patients in J-CaP with a c-index of 0.71, and cancer-specific survival among PADT patients in CaPSURE with a c-index of 0.84. Conclusion The novel J-CAPRA is the first risk instrument developed and validated for patients undergoing PADT. It is applicable to those with both localized and advanced disease, and performs well in diverse populations.

Background Although many tools for the assessment of prostate cancer risk have been published, most are designed to predict only biochemical recurrence, usually after a single specified treatment. We assessed the accuracy of the Cancer of the Prostate Risk Assessment (CAPRA) score, which was validated previously to predict pathological and biochemical outcomes after radical prostatectomy, to predict metastases, prostate cancer – specific mortality, and all-cause mortality. Methods We studied 10 627 men with clinically localized prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor registry, who underwent primary radical prostatectomy, radiation therapy (external beam or interstitial), androgen deprivation monotherapy, or watchful waiting/active surveillance, and had at least 6 months of follow-up after treatment. CAPRA scores were calculated at diagnosis from the prostate-specific antigen level, Gleason score, percentage of biopsy cores that were positive for cancer, clinical tumor stage, and age at diagnosis. Survival was studied with Kaplan – Meier analyses. Associations between increasing CAPRA scores and bone metastasis, cancer-specific mortality, and allcause mortality were examined by use of proportional hazards regression, with adjustment for primary treatment; for all-cause mortality, the analysis also included adjustment for age and comorbidity. Accuracy of the CAPRA score was assessed with the concordance ( c )-index. Results Among the 10 627 patients, 311 (2.9%) men developed bone metastases, 251 (2.4%) died of prostate cancer, and 1582 (14.9%) died of other causes. Each single-point increase in the CAPRA score was associated with increased bone metastases (hazard ratio [HR] for bone metastases = 1.47, 95% confidence interval [CI] = 1.39 to 1.56), cancer-specific mortality (HR for prostate cancer death = 1.39, 95% CI = 1.31 to 1.48), and all-cause mortality (HR for death = 1.13, 95% CI = 1.10 to 1.16). The CAPRA score was accurate for predicting metastases ( c -index = 0.78), cancer-specific mortality ( c -index = 0.80), and all-cause mortality ( c -index = 0.71). Conclusions In a large cohort of patients with clinically localized prostate cancer who were managed with one of five primary modalities, the CAPRA score predicted clinical prostate cancer endpoints with good accuracy. These results support the value of the CAPRA score as a risk assessment and stratification tool for both research studies and clinical practice. J Natl Cancer Inst 2009;101: 878 – 887

Objectives: This study aimed to describe national trends in presentation, management, and outcomes for men with high risk prostate cancer. Methods: Data were abstracted from CaPSURE; 10,808 men were diagnosed between 1990 and 2007 and had complete clinical data. High-risk was defined according to the D'Amico criteria; a more restrictive definition assigned clinical stage T2c to intermediate rather than high risk. Temporal trends were assessed for patient distribution among risk groups, and within the high-risk group for individual risk factors, Kattan nomogram score, Cancer of the Prostate Risk Assessment (CAPRA) score, and primary treatment. Survival analysis stratified by CAPRA score was performed. Results: Under the standard definition, 31.2% of the men were diagnosed with high-risk disease, and 16.9% were high-risk under the restrictive definition. This proportion has fallen over time but has been stable since 2000. Patients who would be stratified to high risk under the standard definition and to intermediate risk under the restrictive definition have better outcomes than those stratified to either intermediate or high risk under both definitions. There has been no consistent risk migration within the high-risk group over time. Treatment varies substantially with CAPRA score within the high-risk group, with higher risk men less likely to receive local therapy. Use of androgen deprivation therapy has increased over time, both as primary therapy and in conjunction with both external beam radiation and brachytherapy. Biochemical outcomes vary according to CAPRA score within the high-risk group. Conclusions: Clinical stage T2c should not define high risk, and the high-risk group should be substratified using a multivariable instrument. There is no evidence for meaningful downward risk migration among high-risk patients over the past 15 years. At least some men in the high-risk group may be undertreated. © Springer-Verlag 2008.

Purpose: We updated national risk trends in prostate cancer with a focus on low risk tumors, reexamined trends in primary treatment for low risk tumors and substratified patients at low risk based on pretreatment clinical data. Materials and Methods: Data were abstracted from the CaPSURE™registry. A total of 10,385 men were diagnosed between 1990 and 2006 with localized disease. Low risk was defined as prostate specific antigen 10 ng/ml or less, Gleason score 6 or less and clinical T stage 2a or less. Temporal trends were assessed for patient distribution among risk groups and in the low risk group for individual risk factors, Kattan nomogram prediction, Cancer of the Prostate Risk Assessment score and primary treatment. The ability of the Cancer of the Prostate Risk Assessment score to substratify low risk prostatectomy cases was evaluated with survival analysis. Results: The proportion of low risk tumors in CaPSURE almost doubled from 27.5% in 1990 to 1994, to 46.4% in 2000 to 2001 but it has been relatively constant since then. A growing proportion of low risk tumors are cT1c and virtually all are Gleason score 6. Prostate specific antigen and the percent of positive biopsies decreased throughout the study period, as did the mean Cancer of the Prostate Risk Assessment score. The use of active surveillance increased from a nadir of 6.2% in 2000 to 2001, to 10.2% in 2004 to 2006. The use of prostatectomy also increased, whereas the use of androgen deprivation and radiation decreased. The likelihood of recurrence increased significantly with increasing Cancer of the Prostate Risk Assessment scores. Conclusions: Patients at low risk can be further substratified to identify those at very low risk based on clinical variables. The use of surveillance is increasing but overtreatment remains a concern in these patients. © 2007 American Urological Association.

BACKGROUND. Studies that compare prostate cancer treatment costs show wide variation. None compare all contemporary treatment costs, and most focus on initial treatment costs. The authors compared healthcare utilization and cost patterns of prostate cancer treatments over a span of 5.5 years in 4553 newly diagnosed patients stratified by age and risk group. METHODS. Contemporary treatment and evaluation patterns for prostate cancer were identified by using CaPSURE, a national disease registry of men with prostate cancer that included ongoing clinical data collection from 31 academic and community urology practices and biennial patient-reported outcome questionnaires that included demography, medical condition, comorbidity, risk measures, and healthcare utilization. Costs of outpatient visits, medications, and hospitalizations were applied from various national sources. Recurrent events analysis (MCF) accounted for left and right censorship. A mixed effects regression model with bootstrapping for skewed cost data quantified the relation between MCF cost, age, and risk. RESULTS. Prostate-related costs in the first 6 months after treatment were $11,495, (from $2586 for watchful waiting (WW) to $24,204 for external beam radiation. After 6 months, average cost was only $3044. Annual cost is $7740, highest for androgen deprivation therapy ($12,590) and lowest for watch waiting ($5843). Risk and age were significantly related to initial treatment choice. Cumulative cost ($42,570) allowed a better estimate of treatment pattern costs. CONCLUSIONS. The cost burden of prostate cancer is high, but it varies by treatment type even when controlling for disease, age, and stage. Cumulative cost analysis allowed inclusion of adverse events and disease recurrence costs, making new cost comparisons evident among treatments. Cancer 2007;109:518–527. © 2006 American Cancer Society.

The optimal approach for treating localized prostate cancer remains controversial, leading to a multifactorial decision making process. We characterized the extent to which the presence and number of comorbidities affects treatment for localized prostate cancer.Data were abstracted from a longitudinal observational database of men with prostate cancer. A total of 5,149 men diagnosed with localized prostate cancer between 1995 and 2001 were included in this analysis if they had been treated with RP, external beam radiation, brachytherapy, hormonal therapy or surveillance. Comorbidity was assessed through a patient reported checklist of conditions. Multinomial logistic regression was used to determine the OR of the likelihood of receiving each type of therapy. The number of comorbidities and specific comorbidities in patients receiving RP were compared with comorbidities in patients receiving other treatment.The adjusted OR showed a dose response between the number of comorbidities and an increasing probability of any nonRP treatment. In addition, heart disease, stroke or another urinary condition were found to be associated with treatment.Patient comorbidities affect decision making regarding treatment for localized prostate cancer. Urologists and other physicians treating this disease appear to evaluate patient comorbidities when selecting treatment options.

Purpose: The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes. Materials and Methods: The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10,000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes. Results: Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother. Conclusions: The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.

Recently published studies suggest a benefit for androgen deprivation therapy (ADT) delivered early in the course of prostate cancer. However, the use of ADT specifically in patients with clinically localized disease or biochemical-disease recurrence after local therapy is not well defined. Potential candidates for primary ADT include patients who are poor candidates for definitive local therapy because of advanced age or comorbid conditions, as well as patients with significant local disease who refuse standard therapy. Treatment strategies designed to minimize the side effects of prolonged therapy, such as intermittent ADT or antiandrogen monotherapy, show promise as alternatives to continuous ADT in some patients. The role of ADT in patients with clinically localized and recurrent prostate cancer, whether it is delivered in a continuous or intermittent fashion, must be determined in randomized, prospective trials.

ContextLow-grade squamous intraepithelial lesions (LSILs) have been described as a benign cytological consequence of active human papillomavirus (HPV) replication. Several studies have reported that certain behavioral and biological risks exist for LSIL, suggesting that HPV alone is not sufficient for the development of LSIL. However, because most of these studies have been cross-sectional, it is not known whether behavioral and biological risks are simply risks for HPV infection itself.ObjectiveTo prospectively examine risks of incident HPV infection in HPV-negative females and of incident LSIL development in females with HPV infection.DesignProspective cohort study conducted between 1990-2000, with a median follow-up of 50 months.Setting and ParticipantsFemales aged 13 to 21 years who attended 2 family planning clinics in the San Francisco bay area; 496 had prevalent HPV infection and 105 were HPV-negative.Main Outcome MeasureIncident development of HPV infection and LSIL, analyzed by various demographic, behavioral, and clinical risk factors.ResultsFifty-four incident HPV infections occurred in the 105 females who were HPV-negative at study entry (median duration of follow-up for those who remained HPV-negative was 26 months). Multivariable analysis showed that risks of HPV included sexual behavior (relative hazard [RH], 10.10; 95% confidence interval [CI], 3.24-31.50 per new partner per month), history of herpes simplex virus (RH, 3.54; 95% CI, 1.37-9.10), and history of vulvar warts (RH, 2.73; 95% CI, 1.27-5.87). Current use of oral contraceptives had a significantly protective effect (RH, 0.49; 95% CI, 0.28-0.86). Among the 496 individuals who were HPV-positive at baseline or in follow-up, there were 109 incident cases of LSIL during the follow-up interval, with a median follow-up time of 60 months for those who never developed LSIL. Human papillomavirus infection was the most significant risk factor for development of LSIL. The multivariable model showed the following risks for LSIL: HPV infection for less than 1 year (RH, 7.40; 95% CI, 4.74-11.57); HPV infection for 1 to 2 years (RH, 10.27; 95% CI, 5.64-18.69); HPV infection for 2 to 3 years (RH, 6.11; 95% CI, 1.86-20.06); and daily cigarette smoking (RH, 1.67; 95% CI, 1.12-2.48).ConclusionOur results indicate distinct risks for HPV and LSIL. In addition, most women with HPV infection in our study did not develop LSIL within a median follow-up period of 60 months. These findings underscore the hypothesis that certain biological risks thought to be associated with LSIL are, in fact, risks for acquisition of HPV. Cigarette smoking was a risk specific to LSIL, supporting the role of tobacco in neoplastic development.

Objectives: To estimate component and total costs of treatment and to examine differences in cost and cost effectiveness between oral antifungal medication and local therapy for patients with toenail onychomycosis. Design: Prospective, observational study of patients with onychomycosis who visited dermatologists and podiatrists in the US. Physicians provided data on clinical management, disease severity, nail improvement and resource utilisation. Patients completed questionnaires on resource utilisation and symptoms at baseline, 4 and 9 months. To estimate costs, reported utilisation was multiplied by unit costs expressed in 1997 US dollars ($US) and derived in 2 ways: first, using Medicare fees; and second, using standard physician fees. Results: After adjustment for key demographic and clinical variables, participants receiving oral medication had higher total costs based on standard fees ($US794 vs $US575) and medication costs ($US564 vs $US109), lower procedure costs ($US0 vs $US122) and physician visit costs ($US200 vs $US330), and greater clinical effectiveness as measured by global improvement rating (86 vs 35%) and Toenail Symptom Index (94 vs 49%). For participants receiving oral medication, 90% of total costs were incurred during the first 4 months of follow-up, whereas for those receiving local therapy, costs were more evenly distributed throughout the study period. Incremental cost-effectiveness analysis showed $US304 to $US491 per additional case improved with oral medication over a 9-month timeframe. Extrapolation of these results using 2 time-points (months 4 and 9) suggested that cost equivalence would be reached 17 to 21 months following the initiation of treatment. Conclusions: During 9 months of follow-up in patients with toenail onychomycosis, the use of oral antifungal medication resulted in superior patient outcomes, but at higher total cost compared with local therapy.