Comparative Effectiveness Analysis Of Surgery And Radiation Research Articles

MP54-06 EFFECT OF SMOKING ON PROSTATE CANCER SURVIVORS' FUNCTION AND QUALITY OF LIFE: AN ANALYSIS OF THE CEASAR (COMPARATIVE EFFECTIVENESS ANALYSIS OF SURGERY AND RADIATION) STUDY

You have accessJournal of UrologyCME1 Apr 2023MP54-06 EFFECT OF SMOKING ON PROSTATE CANCER SURVIVORS' FUNCTION AND QUALITY OF LIFE: AN ANALYSIS OF THE CEASAR (COMPARATIVE EFFECTIVENESS ANALYSIS OF SURGERY AND RADIATION) STUDY David-Dan Nguyen, Daniel A. Barocas, Li-Ching Huang, Zhiguo Zhao, Karen E. Hoffman, Tatsuki Koyama, David F. Penson, and Christopher J.D. Wallis David-Dan NguyenDavid-Dan Nguyen More articles by this author , Daniel A. BarocasDaniel A. Barocas More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Zhiguo ZhaoZhiguo Zhao More articles by this author , Karen E. HoffmanKaren E. Hoffman More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , David F. PensonDavid F. Penson More articles by this author , and Christopher J.D. WallisChristopher J.D. Wallis More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003307.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Tobacco smoking negatively impacts cancer treatment and prognoses. However, there is limited evidence of its effect on cancer survivors' quality of life (QOL) and function. As the natural history of localized prostate cancer (PCa) is protracted, there is a need to identify modifiable risk factors that can influence survivorship, such as tobacco smoking. METHODS: We used 5-year data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a prospective, population-based, observational study of men diagnosed with localized PCa in 2011-2012. We excluded patients that did not complete the smoking-related and baseline questions and those that did not have at least one post-baseline response. Survivors were categorized as never, former, and current smokers. Multivariable linear regression models adjusting for baseline quality of life and function, treatment type, patient characteristics, and disease characteristics were used to assess the association between smoking history and 5-year scores on the 26-Item Expanded Prostate Index Composite (EPIC-26; PCa-specific domains: sexual, urinary incontinence, urinary irritative, bowel, and hormonal) and the Medical Outcomes Study 36-Item Short Form Survey (SF-36; general-health domains: physical, emotional, and energy and fatigue). RESULTS: We included 2185 men of which 109 (5%) were current smokers, 925 (42%) former smokers, and 1151 (53%) never smokers. In unadjusted analyses, current smokers had worse scores on all domains of EPIC-26 and SF-36 compared to never smokers (p<0.05). In adjusted analyses, there was no association between smoking history with EPIC-26 domains (all p>0.05). With regards to SF-36 outcomes, in adjusted analyses, compared to never smokers, current smokers had worse physical function (-7.53, 95%CI -11.16 to -3.89, p<0.01), emotional well-being (-5.03, 95%CI -7.78 to -2.27, p<0.01), and energy and fatigue (-4.51, 95%CI -7.73 to -1.28, p<0.01). Compared to never smokers, former smokers were only found to have worse physical function (-2.46, 95%CI -4.10 to -0.82, p<0.01). There was no interaction between smoking history and treatment (p>0.05). These findings were robust to more lenient definitions of smoking. CONCLUSIONS: PCa survivors that continue to smoke experience worse PCa-specific functional outcomes and physical functioning compared to never smokers. After adjustments, active smoking was associated with clinically relevant worse physical functioning. Tobacco smoking cessation in PCa survivors can enhance QOL and function regardless of initial treatment and should be integrated into survivorship care. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e755 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information David-Dan Nguyen More articles by this author Daniel A. Barocas More articles by this author Li-Ching Huang More articles by this author Zhiguo Zhao More articles by this author Karen E. Hoffman More articles by this author Tatsuki Koyama More articles by this author David F. Penson More articles by this author Christopher J.D. Wallis More articles by this author Expand All Advertisement PDF downloadLoading ...

PD25-03 ASSOCIATION BETWEEN FINANCIAL BURDEN AND TREATMENT REGRET IN MEN WITH LOCALIZED PROSTATE CANCER

You have accessJournal of UrologyCME1 May 2022PD25-03 ASSOCIATION BETWEEN FINANCIAL BURDEN AND TREATMENT REGRET IN MEN WITH LOCALIZED PROSTATE CANCER Daniel D. Joyce, Christopher J. D. Wallis, Li-Ching Huang, Karen E. Hoffman, Zhiguo Zhao, Tatsuki Koyama, Ralph Conwill, David F. Penson, and Daniel A. Barocas Daniel D. JoyceDaniel D. Joyce More articles by this author , Christopher J. D. WallisChristopher J. D. Wallis More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Karen E. HoffmanKaren E. Hoffman More articles by this author , Zhiguo ZhaoZhiguo Zhao More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Ralph ConwillRalph Conwill More articles by this author , David F. PensonDavid F. Penson More articles by this author , and Daniel A. BarocasDaniel A. Barocas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002567.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We sought to understand the association between financial burden and treatment regret in men with localized prostate cancer to better understand the importance of inclusion of financial discussions in patient counseling. METHODS: Utilizing the multicenter, population-based Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) dataset, we identified all men accrued between 2011 and 2012 who underwent surgery, radiation, or active surveillance as primary management for localized prostate cancer. Patient-reported functional outcomes were assessed at baseline and longitudinally through 5 years using the 26-item Expanded Prostate Index Composite questionnaire. Treatment regret was assessed at 3- and 5-year follow-up using Clark’s validated scale. Financial burden was similarly evaluated at 3 and 5 years using a previously published 4-item questionnaire. The association between financial burden and treatment regret was assessed using multivariable logistic regression controlling for demographics, disease characteristics, treatment, functional outcomes, and patient expectations. RESULTS: Of the 2,924 men who met inclusion criteria, both regret and financial burden assessments were available for 80.6% (n=2,359). Prostate cancer management included surgery (n=1,256, 53.2%), radiation (n=787, 33.4%), and active surveillance (n=316, 13.4%). Financial burden from “finances in general” was associated with treatment regret at 3 and 5 years, after adjusting for potential confounders (OR 2.47, 95% CI 1.33, 4.57). Similar associations with financial burden from direct costs, such as treatment (OR 1.02, 95% CI 0.47, 2.21), clinic visit (OR 1.85, 95% CI 0.92, 3.71), and health insurance costs (OR 1.71, 95% CI 0.89, 3.30) were not observed (see Table). CONCLUSIONS: In this representative, population-based sample of men with localized prostate cancer, we observed associations between overall financial burden and treatment regret. The lack of association between treatment regret and measures of financial burden due to direct treatment costs may indicate a more profound impact on patients from indirect costs and should guide future efforts to address financial toxicity in prostate cancer management. Source of Funding: This study was supported by the Agency for Healthcare Research and Quality (1R01HS019356, 1R01HS022640) and the Patient-Centered Outcomes Research Institute (CE-12-11-4667). Data management was facilitated by Vanderbilt University’s Research Electronic Data Capture (REDCap) system, which is supported by the Vanderbilt Institute for Clinical and Translational Research grant (UL1TR000011 from NCATS/NIH) © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e422 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel D. Joyce More articles by this author Christopher J. D. Wallis More articles by this author Li-Ching Huang More articles by this author Karen E. Hoffman More articles by this author Zhiguo Zhao More articles by this author Tatsuki Koyama More articles by this author Ralph Conwill More articles by this author David F. Penson More articles by this author Daniel A. Barocas More articles by this author Expand All Advertisement PDF DownloadLoading ...

Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes.

We aimed to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer longitudinally over 5 years. We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Patient-reported depressive symptoms (Centers for Epidemiologic Studies Depression [CES-D]) and domains of the Medical Outcomes Study 36-item Short Form survey evaluating emotional well-being and energy/fatigue were assessed through 5 years after treatment with surgery, radiotherapy (with or without androgen deprivation therapy) and active surveillance. Regression models were adjusted for outcome-specific baseline function, demographic and clinicopathological characteristics, and treatment approach. A total of 2,742 men (median [quartiles] age 64 [59-70]) met inclusion criteria. Baseline depressive symptoms, as measured by the CES-D, were low (median 4, quartiles 1-8) without differences between groups. We found no effect of treatment modality on depressive symptoms (p=0.78), though older age, poorer health, being unmarried and baseline CES-D score were associated with declines in mental health. There was no clinically meaningful association between treatment modality and scores for either emotional well-being (p=0.81) or energy/fatigue (p=0.054). This prospective, population-based cohort study of men with localized prostate cancer showed no clinically important differences in mental health outcomes including depressive symptoms, emotional well-being, and energy/fatigue according to the treatment received (surgery, radiotherapy, or surveillance). However, we identified a number of characteristics associated with worse mental health outcomes including: older age, poorer health, being unmarried, and baseline CES-D score which may allow for early identification of patients most at risk of these outcomes following treatment.

Association between adherence to radiation therapy quality metrics and patient reported outcomes in prostate cancer.

Prior studies have shown significant variability in the quality of prostate cancer care in the US with questionable associations between quality measures and patient reported outcomes. We evaluated the impact of compliance with nationally recognized radiation therapy (RT) quality measures on patient-reported health-related quality of life (HRQOL) outcomes in the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) cohort. CEASAR is a population-based, prospective cohort study of men with localized prostate cancer from which we identified 649 who received primary RT and completed HRQOL surveys for inclusion. Eight quality measures were identified based on national guidelines. We analyzed the impact of compliance with these measures on HRQOL assessed by the 26-item Expanded Prostate Index Composite at pre-specified intervals up to 5 years after treatment. Multivariable analysis was performed controlling for demographic and clinicopathologic features. Among eligible participants, 566 (87%) patients received external beam radiation therapy and 83 (13%) received brachytherapy. Median age was 69 years (interquartile range: 64-73), 33% had low-, 43% intermediate-, and 23% high-risk disease. 28% received care non-compliant with at least one measure. In multivariable analyses, while some statistically significant associations were identified, there were no clinically significant associations between compliance with evaluated RT quality measures and patient reported urinary irritative, urinary incontinence, bowel, sexual or hormonal function. Compliance with RT quality measures was not meaningfully associated with patient-reported outcomes after prostate cancer treatment. Further work is needed to identify patient-centered quality measures of prostate cancer care.

Association between pelvic nodal radiotherapy and patient-reported functional outcomes through 5 years among men undergoing external-beam radiotherapy for prostate cancer: An assessment of the comparative effectiveness analysis of surgery and radiation (CEASAR) cohort.

The role of pelvic irradiation in men receiving external beam radiotherapy (EBRT) for prostate cancer is unclear, in part due to a lack of data on patient-reported outcomes. We sought to compare functional outcomes for men receiving prostate and pelvic versus prostate-only radiotherapy, longitudinally over 5 years. We performed a population-based, prospective cohort study of men with clinically-localized prostate cancer undergoing EBRT. We examined the effect of prostate and pelvic (n = 102) versus prostate-only (n = 485) radiotherapy on patient-reported disease-specific (using the Expanded Prostate Cancer Index Composite[EPIC]-26) and general health-related (using the SF-36) function, over 5 years. Regression models were adjusted for outcome-specific baseline function, clinicopathologic characteristics, and androgen deprivation therapy (ADT). 587 men (median [quartiles] age 69 [64-73] years) met inclusion criteria and completed ≥1 post-treatment survey. More men treated with prostate and pelvic radiotherapy had high-risk disease (58% vs. 18%, P < 0.01) and received ADT (75% vs. 41%, P < 0.01). These men reported worse sexual (6 months-5 years), hormonal (at 6 months), and physical (6 months-5 years) function. Accounting for baseline function, patient and tumor characteristics, and use of ADT, pelvic irradiation was not associated with statistically or clinically significant differences in bowel function, urinary incontinence, irritative voiding symptoms or sexual function through 5-years (all P > 0.05). Marginally clinically important differences were noted in hormonal function at 3-years (adjusted mean difference 4.7, 95% confidence interval [1.2-8.3]; minimally clinically important difference (MCID) 4 to 6) and 5-years (4.2, [0.4-8.0]) following treatment. After adjustment, there was a transient statistically significant, but not clinically important, difference in emotional well-being at 6 months (3.0, [0.19-5.8]; MCID 6) that resolved by 1 year and no differences in physical functioning or energy and fatigue. This prospective, population-based cohort study of men with localized prostate cancer treated with EBRT, showed no clinically important differences in disease-specific or general health-related quality of life with the addition of pelvic irradiation to prostate radiotherapy, supporting the use of pelvic radiotherapy when it may be of clinical benefit, such as men with increased risk of nodal involvement.

This Month in Adult Urology

This Month in Adult Urology

Patient-Reported Financial Toxicity Associated with Contemporary Treatment for Localized Prostate Cancer.

Contemporary treatment modalities for localized prostate cancer provide comparable overall and cancer-specific survival. However, the degree of financial burden imposed by treatment, the factors contributing to that burden, and how different treatments compare with regard to financial toxicity remain poorly understood. The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study enrolled men with localized prostate cancer from 2011 to 2012. Questionnaires were collected at 6, 12, 36, and 60 months after enrollment. Differences in patient-reported financial burden were compared between active surveillance, radical prostatectomy, and external beam radiotherapy using multivariable logistic regression. Among 2,121 patients meeting inclusion criteria, 15% reported large or very large burden of treatment costs within 6 months, declining to 3% by year 5. When controlling for age, education, income and other covariates, external beam radiotherapy was associated with greater financial burden than active surveillance and radical prostatectomy at 1 year (OR 2.2, 95% CI 1.2-4.1 and OR 1.5, 95% CI 1.0-2.3, respectively) and 3 years (OR 3.1 95% CI 1.1-8.8 and OR 2.1, 95% CI 1.2-3.7, respectively). Radical prostatectomy and active surveillance had similar rates of financial burden at all time points. Age, race, education, and D'Amico risk group were associated with financial burden. External beam radiotherapy was associated with the highest financial burden, even when controlling for age, education and income. Prospective studies that directly measure out-of-pocket and indirect costs and account more thoroughly for baseline socioeconomic differences are warranted in order to identify those most at risk.

Radiotherapy after radical prostatectomy: Effect of timing of postprostatectomy radiation on functional outcomes

Introduction and objectiveThe timing of radiotherapy (RT) after prostatectomy is controversial, and its effect on sexual, urinary, and bowel function is unknown. This study seeks to compare patient-reported functional outcomes after radical prostatectomy (RP) and postprostatectomy radiation as well as elucidate the timing of radiation to allow optimal recovery of function. MethodsThe Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study of men with localized prostate cancer. Patient-reported sexual, urinary, and bowel functional outcomes were measured using the 26-item Expanded Prostate Index Composite at baseline and at 6, 12, 36, and 60 months after enrollment. Functional outcomes were compared among men undergoing RP alone, post-RP adjuvant radiation (RP + aRT), and post-RP salvage radiation (RP + sRT) using multivariable models controlling for baseline clinical, demographic, and functional characteristics. ResultsAmong 1,482 CEASAR participants initially treated with RP for clinically localized prostate cancer, 11.5% (N = 170) received adjuvant (aRT, N = 57) or salvage (sRT, N = 113) radiation. Men who received post-RP RT had worse scores in all domains (sexual function [−9.0, 95% confidence interval {−14.5, −3.6}, P < 0.001], incontinence [−8.8, {−14.0, −3.6}, P < 0.001], irritative voiding [−5.9, {−9.0, −2.8}, P < 0.001], bowel irritative [−3.5, {-5.8, −1.2}, P = 0.002], and hormonal function [−4.5, {−7.2, −1.7}, P = 0.001]) compared to RP alone at 5 years of follow-up. Compared to men treated with RP alone in an adjusted linear model, sRT was associated with significantly worse scores in all functional domains. aRT was associated with significantly worse incontinence, urinary irritation, and hormonal function domain scores compared to RP alone at 5 years of follow-up. On multivariable modeling, RT administered approximately 24 months after RP was associated with the smallest decline in sexual domain score, with an adjusted mean decrease of 8.85 points (95% confidence interval [−19.8, 2.1]) from post-RP, pre-RT baseline. ConclusionsIn men with localized prostate cancer, post-RP RT was associated with significantly worse sexual, urinary, and bowel function domain scores at 5 years compared to RP alone. Radiation delayed for approximately 24 months after RP may be optimal for preserving erectile function compared to radiation administered closer to the time of RP.

MP67-17 ASSOCIATION BETWEEN TREATMENT FOR LOCALIZED PROSTATE CANCER AND MENTAL HEALTH OUTCOMES

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy III (MP67)1 Apr 2020MP67-17 ASSOCIATION BETWEEN TREATMENT FOR LOCALIZED PROSTATE CANCER AND MENTAL HEALTH OUTCOMES Amy Luckenbaugh*, Daniela Wittmann, Ann Arbor, MI, Zighuo Zhao, Tatsuki Koyama, Li-Ching Huang, Aaron Laviana, Christopher Wallis, Karen Hoffman, David Penson, and Daniel Barocas Amy Luckenbaugh*Amy Luckenbaugh* More articles by this author , Daniela WittmannDaniela Wittmann More articles by this author , Ann Arbor, MIAnn Arbor, MI More articles by this author , Zighuo ZhaoZighuo Zhao More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Aaron LavianaAaron Laviana More articles by this author , Christopher WallisChristopher Wallis More articles by this author , Karen HoffmanKaren Hoffman More articles by this author , David PensonDavid Penson More articles by this author , and Daniel BarocasDaniel Barocas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000947.017AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Management options for localized prostate cancer are similar with respect to intermediate-term survival outcomes and differ with respect to disease-specific functional outcomes. However, little is known about the impact of prostate cancer treatment on mental health. In this context, we evaluated the association between prostate cancer treatment choice and patient-reported mental health outcomes over time. METHODS: We enrolled a population-based cohort of men who underwent active surveillance, surgery or radiation therapy as part of the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Depression (using the CES-D score, range 0-27, higher score indicating worse depression) and emotional well-being, energy and vitality (using the SF-36, range 0-100, higher scores indicating better function) were evaluated longitudinally through five years. Patients who did not complete at least one CES-D or SF-36 follow-up survey were excluded from the analysis. Univariate and multivariate analysis were performed to assess factors associated with CES-D and SF-36 scores. RESULTS: Among 1509 (52.4%) patients undergoing radical prostatectomy, 961 (33.4%) undergoing radiation therapy and 409 (14.2%) undergoing active surveillance there were no significant differences in CES-D or SF-36 scores between treated patients and those undergoing active surveillance (Table 1). The most significant predictors of decline in CES-D score included: older age (p=0.0075), poor overall health (p<0.0001), being unmarried (p<0.0195) and lower baseline CES-D score (p<0.0001). Baseline sexual function and urinary control were not correlated with longitudinal CES-D scores. Similar factors were found to be correlated with SF-36 emotional well-being, energy and vitality scores. CONCLUSIONS: Treatment with surgery or radiation was not associated with depression symptoms, or emotional well-being, energy, and vitality scores when compared to active surveillance through five years. Factors associated with development of declining mental health included: older age, being unmarried, poor overall health and lower baseline scores. Further analysis is warranted to determine if post-treatment sexual, urinary and bowel function are associated with longitudinal changes in mental health. Source of Funding: Grants (1R01HS019356 and 1R01HS022640) from the Agency for Healthcare Research and Quality and an award (CE12-11- 4667) from the Patient-Centered Outcomes Research Institute. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1031-e1032 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Amy Luckenbaugh* More articles by this author Daniela Wittmann More articles by this author Ann Arbor, MI More articles by this author Zighuo Zhao More articles by this author Tatsuki Koyama More articles by this author Li-Ching Huang More articles by this author Aaron Laviana More articles by this author Christopher Wallis More articles by this author Karen Hoffman More articles by this author David Penson More articles by this author Daniel Barocas More articles by this author Expand All Advertisement PDF downloadLoading ...

MP53-06 RADIOTHERAPY AFTER RADICAL PROSTATECTOMY: EFFECT OF TIMING OF POST-PROSTATECTOMY RADIATION ON FUNCTIONAL OUTCOMES

You have accessJournal of UrologyProstate Cancer: Localized: Radiation Therapy (MP53)1 Apr 2020MP53-06 RADIOTHERAPY AFTER RADICAL PROSTATECTOMY: EFFECT OF TIMING OF POST-PROSTATECTOMY RADIATION ON FUNCTIONAL OUTCOMES Heather Huelster*, Aaron Laviana, Daniel Joyce, Tatsuki Koyama, Zhiguo Zhao, Li-Ching Huang, Karen Hoffman, Ralph Conwill, David Penson, and Daniel Barocas Heather Huelster*Heather Huelster* More articles by this author , Aaron LavianaAaron Laviana More articles by this author , Daniel JoyceDaniel Joyce More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Zhiguo ZhaoZhiguo Zhao More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Karen HoffmanKaren Hoffman More articles by this author , Ralph ConwillRalph Conwill More articles by this author , David PensonDavid Penson More articles by this author , and Daniel BarocasDaniel Barocas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000915.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The timing of radiation after prostatectomy is controversial, and its effect on patient-reported sexual, urinary, and bowel function is unknown. This study seeks to compare outcomes after radical prostatectomy (RP) and post-prostatectomy radiation as well as elucidate the timing of radiation to allow optimal recovery of function. METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based study of men with localized prostate cancer. Patient-reported functional outcomes were measured using the 26-item Expanded Prostate Index Composite (EPIC-26) at baseline and 6, 12, 36, and 60 months after enrollment. Functional outcomes were compared using multivariable models controlling for baseline demographic and clinical characteristics. RESULTS: Among 1482 CEASAR participants initially treated with RP for clinically localized prostate cancer, 11.5% (N=170) received adjuvant (N=57) or salvage (N=113) external beam radiotherapy. Men who received post-RP radiotherapy had worse scores in all domains compared to RP alone at 5 years of follow up. Compared to men treated with RP alone in an adjusted linear model, salvage radiation was associated with significantly worse domain scores for sexual function (-11.1, 95%CI [-17.0, - 5.3], p<0.001), incontinence (-7.6, [-13.6, -1.6], p=0.014), urinary irritation (-6.1, [-9.7, -2.4], p=0.001), bowel function (-4.5, [-7.4, -1.7], p=0.002), and hormonal function (-3.3, [-6.0, -0.6], p=0.017). Adjuvant radiation was associated with significantly worse incontinence (-11.9, [-20.7, -3.1], p=0.008), urinary irritation (-5.9, [-11.2, -0.6], p=0.030), and hormonal function (-7.3, [-13.6, -1.0], p=0.023) domain scores compared to RP alone at 5 years of follow up. On multivariable regression analysis, radiotherapy administered at 24 months after RP was associated with the smallest decline in sexual domain score, with an adjusted mean difference of -5.3 points (p=0.016) from post-RP baseline. CONCLUSIONS: In men with localized prostate cancer, post-prostatectomy radiation was associated with significantly worse EPIC-26 sexual, urinary, and bowel function domain scores at 5 years compared to RP alone. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e783-e784 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Heather Huelster* More articles by this author Aaron Laviana More articles by this author Daniel Joyce More articles by this author Tatsuki Koyama More articles by this author Zhiguo Zhao More articles by this author Li-Ching Huang More articles by this author Karen Hoffman More articles by this author Ralph Conwill More articles by this author David Penson More articles by this author Daniel Barocas More articles by this author Expand All Advertisement PDF downloadLoading ...

Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes?

The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question. Using data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a multicenter, prospective study of men diagnosed with localized prostate cancer, we analyzed 11,464 EPIC-26 questionnaires from a total of 2,563 men at baseline through 60 months of followup who were treated with robotic prostatectomy, radiotherapy or active surveillance. We dichotomized every item into its best possible outcome and assessed the percent of men at each domain score who achieved the best result. For every EPIC-26 item the frequency of the best possible outcome was reported by domain score category. For example, a score of 80 to 100 on sexual function corresponded to 97% of men reporting erections sufficient for intercourse while at a score of 40 to 60 only 28% reported adequate erections. Also, at a score of 80 to 100 on the urinary incontinence domain 93% of men reported rarely or never leaking vs 6% at a score of 61 to 80. Our findings indicate a novel way to interpret EPIC-26 domain scores, demonstrating large variations in the percent of respondents reporting the best possible outcomes over narrow domain score differences. This information may be valuable when counseling men on treatment options.

Effect of Prostate Cancer Severity on Functional Outcomes After Localized Treatment: Comparative Effectiveness Analysis of Surgery and Radiation Study Results

BackgroundWhether prostate cancer severity modifies patient-reported functional outcomes after radical prostatectomy (RP) or external beam radiotherapy (EBRT) for localized cancer is unknown. ObjectiveThe purpose of this study was to determine whether differences in predicted function over time between RP and EBRT varied by risk group. Design, setting, and participantsThe Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study that enrolled men with localized prostate cancer in 2011–2012. Among 2117 CEASAR participants who underwent RP or EBRT, 817 had low-risk, 902 intermediate-risk, and 398 high-risk disease. Outcome measurements and statistical analysisPatient-reported, disease-specific function was measured using the 26-item Expanded Prostate Index Composite (at baseline and 6, 12, and 36 mo). Predicted function was estimated using regression models and compared by disease risk. Results and limitationsLow-risk EBRT patients reported 3-yr sexual function scores 12 points higher than those of low-risk RP patients (RP, 39 points [95% confidence interval {CI}, 37–42] vs EBRT, 52 points [95% CI, 47–56]; p<0.001). The difference in 3-yr scores for high-risk patients was not clinically significant (RP, 32 points [95% CI, 28–35] vs EBRT, 38 points [95% CI, 33–42]; p=0.03). However, when using a commonly used binary definition of sexual function (erections firm enough for intercourse), no major differences were noted between RP and EBRT at 3 yr across low-, intermediate-, and high-risk disease strata. No clinically significant interactive effects between treatment and cancer severity were observed for incontinence, bowel, irritative voiding, and hormone domains. The primary limitation is the lack of firmly established thresholds for clinically significant differences in Expanded Prostate Index Composite domain scores. ConclusionsFor men with low-risk prostate cancer, EBRT was associated with higher sexual function scores at 3 yr than RP; however, for men with high-risk prostate cancer, no clinically significant difference was noted. Men with high-risk prostate cancer should be counseled that EBRT and RP carry similar sexual function outcomes at 3 yr. Patient summaryIn this report, we studied the urinary, sexual, bowel, and hormonal functions of patients 3 yr after undergoing prostate cancer surgery or radiation. We found that for patients with high-risk disease, sexual function was similar between surgery and radiation. We conclude that high-risk patients undergoing radiation therapy should be counseled that sexual function may not be as good as low-risk patients undergoing radiation.

The Effect of Nerve Sparing Status on Sexual and Urinary Function: 3-Year Results from the CEASAR Study

Nerve sparing contributes to the recovery of sexual and urinary function after radical prostatectomy but it may be ineffective in some patients or carry the risk of a positive surgical margin. We evaluated sexual and urinary function outcomes according to the degree of nerve sparing in patients with prostate cancer treated with radical prostatectomy. The CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study is a prospective, population based, observational study of men diagnosed with localized prostate cancer in 2011 to 2012. Patient reported sexual and urinary functions were measured using the 26-item Expanded Prostate Index Composite at baseline within 6 months after diagnosis, and 6, 12 and 36 months after enrollment. Study inclusion criteria included radical prostatectomy as primary treatment, documentation of nerve sparing status and absent androgen deprivation therapy. Nerve sparing status was defined as none, unilateral or bilateral according to the operative report. The final analytical cohort included 991 men. The 11 men treated with unilateral nerve sparing and the 75 treated with a nonnerve sparing procedure were grouped together. In the multivariable model there was a significant difference in the sexual function score 3 years after radical prostatectomy in the bilateral nerve sparing group compared with the unilateral and nonnerve sparing group (6.1 points, 95% CI 2.0-10.3, p = 0.004). This was more pronounced in men with high baseline sexual function (8.23 points, 95% CI 1.6-14.8, p = 0.014) but not in those with low baseline function (4.0 points, 95% CI -0.6-8.7, p = 0.090). Similar effects were demonstrated on urinary incontinence scores. Bilateral nerve sparing resulted in better sexual and urinary function outcomes than unilateral or nonnerve sparing but the difference was not significant in men with low baseline sexual function.

PD47-01 THE EFFECT OF PROSTATE CANCER TREATMENT ON PATIENT REPORTED URINARY AND SEXUAL FUNCTION VARIES BY DISEASE SEVERITY: 3-YEAR RESULTS FROM THE CEASAR STUDY

You have accessJournal of UrologyProstate Cancer: Epidemiology & Natural History III1 Apr 2017PD47-01 THE EFFECT OF PROSTATE CANCER TREATMENT ON PATIENT REPORTED URINARY AND SEXUAL FUNCTION VARIES BY DISEASE SEVERITY: 3-YEAR RESULTS FROM THE CEASAR STUDY Mark Tyson, JoAnn Alvarez, Tatsuki Koyama, Matthew Resnick, David Penson, and Daniel Barocas Mark TysonMark Tyson More articles by this author , JoAnn AlvarezJoAnn Alvarez More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Matthew ResnickMatthew Resnick More articles by this author , David PensonDavid Penson More articles by this author , and Daniel BarocasDaniel Barocas More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2361AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Disease severity may modulate the effects of prostate cancer treatment on patient-reported functional outcomes. The objective of this study is to determine how the effects of contemporary prostate cancer treatments on functional outcomes vary by disease risk. METHODS The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study which enrolled men with localized prostate cancer in 2011 and 2012. Patient-reported function was measured using the 26-item Expanded Prostate Index Composite (EPIC) at baseline, 6, 12, and 36 months after treatment. To identify differences in the effect of treatment on EPIC domain scores by disease risk, we fit a set of longitudinal models with interactions between disease risk and treatment type (radical prostatectomy [RP] or external beam radiotherapy [EBRT]) with adjustments for the following factors: time since treatment, pre-treatment function, age, race, comorbidity, educational attainment, insurance type, employment, marital status, physical function score, social support, depression score, participatory decision-making score, and study site. RESULTS Among the 2544 participants, 1144 (45%) had low-risk, 983 (39%) had intermediate-risk, and 417 (16%) had high-risk disease. Among low-risk patients, RP causes more severe decreases in sexual function compared to EBRT at 3 years (mean difference in EPIC score: -14.30 [95% CI: -18.56, -10.53]); however, among high-risk patients, this difference becomes both clinically and statistically insignificant (-4.46 [-9.79, 0.88]). With respect to incontinence, RP leads to even greater declines in function among high-risk patients compared to EBRT at 3 years (difference in treatment effects among low risk: -14.60 [-18.00, -11.19] and high risk: -19.25 [-23.87, -14.62]). No clinically significant interactions between treatment and risk were detected among the bowel, hormone, or urinary irritative domains. CONCLUSIONS These data suggest that the effect of treatment on urinary incontinence and sexual function vary by disease risk. Namely, high-risk patients report similar sexual function at 3 years regardless of treatment type but more drastic declines in urinary incontinence after surgery. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e896 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Mark Tyson More articles by this author JoAnn Alvarez More articles by this author Tatsuki Koyama More articles by this author Matthew Resnick More articles by this author David Penson More articles by this author Daniel Barocas More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Racial Variation in Patient-Reported Outcomes Following Treatment for Localized Prostate Cancer: Results from the CEASAR Study

BackgroundRelatively little is known about the relationship between race/ethnicity and patient-reported outcomes after contemporary treatments for localized prostate cancer. ObjectiveTo test the hypothesis that treatment-related changes in urinary, bowel, sexual, and hormonal function vary by race/ethnicity. Design, setting, and participantsThe Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study that enrolled 3708 men diagnosed with localized prostate cancer in 2011–2012. Outcome measurements and statistical analysisPatient-reported disease-specific function was measured using the 26-item Expanded Prostate Index Composite (EPIC) at baseline and 6 and 12 mo after enrollment. Mean treatment differences in function were compared by race using risk-adjusted generalized estimating equations. Results and limitationsWhile all race/ethnic groups reported considerable declines in scores for urinary incontinence after radical prostatectomy (RP) when compared to active surveillance, African-American men reported a greater difference than white men did (adjusted difference-in-differences 8.4 points, 95% confidence interval 2.0–14.8; p=0.01). No difference in bother scores was noted and the overall proportion of explained variation attributable to race/ethnicity was relatively small in comparison to primary treatment and baseline function. No clinically significant racial variation was noted for the sexual, bowel, irritative voiding, or hormone domains. Limitations include the lack of well-established thresholds for clinical significance using the EPIC instrument. ConclusionWhile these data demonstrate that incontinence at 1 yr after RP may be worse for African-American compared to white men, the difference appears to be modest overall. Treatment selection and baseline function explain a much greater proportion of the variation in function after treatment. Patient summaryWe observed that the effect of treatment for prostate cancer on patient-reported function did not vary dramatically by race/ethnicity. Compared to white men, African-American men experienced a somewhat more pronounced decline in urinary continence after radical prostatectomy, but the corresponding changes in bother scores were not significantly different between the two groups.

More Judicious Use of Expectant Management for Localized Prostate Cancer during the Last 2 Decades

Urologists have been criticized for overtreating men with low riskprostate cancer and for passively observing older men with higher risk disease. Proponents of active surveillance for low risk disease and critics of watchful waiting for higher risk disease have advocated for more judicious use of observation. Thus, we compared 2 population based cohorts to determine how expectant management has evolved during the last 2 decades. A total of 5,871 men with localized prostate cancer were enrolled in the PCOS (Prostate Cancer Outcomes Study) or the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study. We compared the use of definitive treatment vs expectant management (watchful waiting or active surveillance) across cohorts, focusing on the influence of disease risk, age and comorbidities. Use of watchful waiting or active surveillance was similar in PCOSand CEASAR (14% in each). Compared to the PCOS, more men in the CEASAR study with low risk disease selected watchful waiting or active surveillance (25% vs 15%, respectively), whereas fewer men with intermediate (7% vs 14%) and high risk (3% vs 10%) disease chose watchful waiting or active surveillance (p <0.001 for each). The association of disease risk with watchful waiting or active surveillance was significantly larger in CEASAR than in PCOS (OR 7.3, 95% CI 3.4 to 15.7). Older age was associated with watchful waiting or active surveillance in both cohorts but there was no association between comorbidity and watchful waiting or active surveillance in the CEASAR study. Use of watchful waiting or active surveillance was more aligned with disease risk in CEASAR compared to PCOS, suggesting there has been a pivot from watchful waiting to active surveillance. While older men were more likely to be observed, comorbidity had little, if any, influence.

PD12-03 IMPACT OF ADHERENCE TO QUALITY MEASURES FOR LOCALIZED PROSTATE CANCER ON HEALTH-RELATED QUALITY OF LIFE OUTCOMES

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness II1 Apr 2015PD12-03 IMPACT OF ADHERENCE TO QUALITY MEASURES FOR LOCALIZED PROSTATE CANCER ON HEALTH-RELATED QUALITY OF LIFE OUTCOMES William Sohn, Sharon Phillips, Brock O'neil, Matthew Resnick, Tatsuki Koyama, David Penson, Daniel Barocas, and CEASAR Investigators William SohnWilliam Sohn More articles by this author , Sharon PhillipsSharon Phillips More articles by this author , Brock O'neilBrock O'neil More articles by this author , Matthew ResnickMatthew Resnick More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , David PensonDavid Penson More articles by this author , Daniel BarocasDaniel Barocas More articles by this author , and CEASAR InvestigatorsCEASAR Investigators More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1055AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Quality indicators endorsed by national quality consortia have yet to be validated with clinical outcomes. Our objective was to determine the impact of adherence to quality indicators for localized prostate cancer on health-related quality of life (HRQOL) outcomes. METHODS The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a population-based, prospective cohort study that enrolled 3691 men with clinically localized prostate cancer during 2011 and 2012, of which 2781 underwent chart abstraction. Compliance with seven quality indicators endorsed by National Quality Forum (NQF), Physician Consortium for Performance Improvement (PCPI) and Physician Quality Reporting Initiative (PQRI), was assessed. Multivariable regression was used to determine the relationship between the compliance of each indicator with scores obtained from the Expanded Prostate Cancer Index Composite (EPIC) instrument, while controlling for treatment type, patient characteristics, and disease characteristics. RESULTS Overall rates of compliance with these quality measures ranged between 64–88%. Rates of compliance with documentation-related measures were higher than for other processes of care. Three of the seven measures were weakly associated with some of the 6- and/or 12-month EPIC domain scales for sexual function and bowel function (table), while the remaining measures had no significant effect on patient-reported HRQOL. These differences in score are unlikely to be clinically meaningful changes. Other EPIC domains (irritative and incontinence) were not significantly associated with compliance with quality indicators. CONCLUSIONS While three of seven nationally endorsed quality indicators had statistically significant associations with EPIC scores, the magnitude of these relationships were not clinically significant. Compliance with these measures does not seem to influence patient-centered outcomes within 12 months. It is possible that composite measures of quality would have more of an effect on these outcomes. It is also possible that these measures may influence other outcomes, such as indices of value or efficiency. We propose that national quality consortia should indicate the anticipated effect of adherence to quality measures, so that the value of adherence to these measures can be ascertained objectively. Quality Measure Compliance Rate EPIC1 Coefficient2 p-value Avoidance of bone scan in men with low-risk tumors 76.5% No significant associations Use of bone scan in appropriately selected patients (high risk) 73.1% No significant associations ADT for High Risk patients undergoing XRT 75.0% No significant associations Documentation cT stage, biopsy Gleason at new diagnosis 72.2% Sexual 6 month 3.94 0.02 Sexual 12 month 3 0.04 Documentation of DRE, cT stage, biopsy Gleason prior to 1° therapy 64.0% Sexual 6 month 3.14 0.03 Documentation of discussion of treatment options 85.9% No significant associations Documentation of pathologic T and N stage, Gleason score, and margin status on pathology report 87.6% Bowel 6 month 1.8 0.03 (1) EPIC Summary Scores 0 to 100 (2) Adjusting for age, race, education level, income, insurance, marital status, employment status, comorbidities, biopsy gleason, PSA, cT stage, and SEER site © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e256-e257 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information William Sohn More articles by this author Sharon Phillips More articles by this author Brock O'neil More articles by this author Matthew Resnick More articles by this author Tatsuki Koyama More articles by this author David Penson More articles by this author Daniel Barocas More articles by this author CEASAR Investigators More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The Evolution of Self-Reported Urinary and Sexual Dysfunction over the Last Two Decades: Implications for Comparative Effectiveness Research

BackgroundDespite the paramount importance of patient-reported outcomes, little is known about the evolution of patient-reported urinary and sexual function over time. ObjectiveTo evaluate differences in pretreatment urinary and sexual function in two population-based cohorts of men with prostate cancer enrolled nearly 20 yr apart. Design, setting, and participantsPatients were enrolled in the Prostate Cancer Outcomes Study (PCOS) or the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study, two population-based cohorts that enrolled patients with incident prostate cancer from 1994 to 1995 and from 2011 to 2012, respectively. Participants completed surveys at baseline and various time points thereafter. Outcome measurements and statistical analysisWe performed multivariable logistic and linear regression analysis to investigate differences in pretreatment function between studies. Results and limitationsThe study comprised 5469 men of whom 2334 (43%) were enrolled in PCOS and 3135 (57%) were enrolled in CEASAR. Self-reported urinary incontinence was higher in CEASAR compared with PCOS (7.7% vs 4.7%; adjusted odds ratio [OR]: 1.83; 95% confidence interval [CI], 1.39–2.43). Similarly, self-reported erectile dysfunction was more common among CEASAR participants (44.7% vs 24.0%) with an adjusted OR of 3.12 (95% CI, 2.68–3.64). Multivariable linear regression models revealed less favorable self-reported baseline function among CEASAR participants in the urinary incontinence and sexual function domains. The study is limited by its observational design and possibility of unmeasured confounding. ConclusionsReporting of pretreatment urinary incontinence and erectile dysfunction has increased over the past two decades. These findings may reflect sociological changes including heightened media attention and direct-to-consumer marketing, among other potential explanations. Patient summaryPatient reporting of urinary and sexual function has evolved and is likely contingent on continually changing societal norms. Recognizing the evolving nature of patient reporting is essential in efforts to conduct high-quality, impactful comparative effectiveness research.

Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: Defining the population at risk for harms of prostate cancer treatment

The authors investigated the prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction in a contemporary, population-based prostate cancer cohort. They also explored the associations between baseline function and age, comorbidity, and timing of baseline survey completion with respect to treatment. The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a population-based, prospective cohort study that enrolled 3691 men with incident prostate cancer during 2011 and 2012. Pretreatment function was ascertained using the Expanded Prostate Cancer Index-26 (EPIC-26). Data were stratified by age, comorbidity, and timing of baseline survey completion with respect to treatment. Unadjusted and multivariable linear regression analyses were performed to evaluate the relations between exposures and pretreatment function. After applying exclusion criteria, the study cohort comprised 3072 men. A strikingly high proportion of men reported inability to obtain erections satisfactory for intercourse (45%) and some degree of urinary incontinence (17%) at baseline. Sexual function was particularly age-sensitive, with patients aged ≤60 years reporting summary scores in excess of 30 points higher than patients aged ≥75 years (P < .001). Compared with the healthiest men, highly comorbid patients reported less favorable function in each domain, including urinary incontinence (summary score, 89.5 vs 74.1; P < .001) and sexual function (summary score, 70.8 vs 32.9; P < .001). Although statistically significant differences in summary scores were identified between patients who completed the baseline questionnaire before treatment (52%) versus after treatment (48%), the absolute differences were small (range, 1-3 points). Patients with newly diagnosed prostate cancer exhibit a wide distribution of pretreatment function. The current data may be used to redefine the population "at risk" for treatment-related harms.