Association Between Radiation Therapy, Surgery, or Observation for Localized Prostate Cancer and Patient-Reported Outcomes After 3 Years.

Importance: Understanding the adverse effects of contemporary approaches to localized prostate cancer treatment could inform shared decision making. Objective: To compare functional outcomes and adverse effects associated with radical prostatectomy, external beam radiation therapy (EBRT), and active surveillance. Design, Setting, and Participants: Prospective, population-based, cohort study involving 2550 men (≤80 years) diagnosed in 2011-2012 with clinical stage cT1-2, localized prostate cancer, with prostate-specific antigen levels less than 50 ng/mL, and enrolled within 6 months of diagnosis. Exposures: Treatment with radical prostatectomy, EBRT, or active surveillance was ascertained within 1 year of diagnosis. Main Outcomes and Measures: Patient-reported function on the 26-item Expanded Prostate Cancer Index Composite (EPIC) 36 months after enrollment. Higher domain scores (range, 0-100) indicate better function. Minimum clinically important difference was defined as 10 to 12 points for sexual function, 6 for urinary incontinence, 5 for urinary irritative symptoms, 5 for bowel function, and 4 for hormonal function. Results: The cohort included 2550 men (mean age, 63.8 years; 74% white, 55% had intermediate- or high-risk disease), of whom 1523 (59.7%) underwent radical prostatectomy, 598 (23.5%) EBRT, and 429 (16.8%) active surveillance. Men in the EBRT group were older (mean age, 68.1 years vs 61.5 years, P < .001) and had worse baseline sexual function (mean score, 52.3 vs 65.2, P < .001) than men in the radical prostatectomy group. At 3 years, the adjusted mean sexual domain score for radical prostatectomy decreased more than for EBRT (mean difference, -11.9 points; 95% CI, -15.1 to -8.7). The decline in sexual domain scores between EBRT and active surveillance was not clinically significant (-4.3 points; 95% CI, -9.2 to 0.7). Radical prostatectomy was associated with worse urinary incontinence than EBRT (-18.0 points; 95% CI, -20.5 to -15.4) and active surveillance (-12.7 points; 95% CI, -16.0 to -9.3) but was associated with better urinary irritative symptoms than active surveillance (5.2 points; 95% CI, 3.2 to 7.2). No clinically significant differences for bowel or hormone function were noted beyond 12 months. No differences in health-related quality of life or disease-specific survival (3 deaths) were noted (99.7%-100%). Conclusions and Relevance: In this cohort of men with localized prostate cancer, radical prostatectomy was associated with a greater decrease in sexual function and urinary incontinence than either EBRT or active surveillance after 3 years and was associated with fewer urinary irritative symptoms than active surveillance; however, no meaningful differences existed in either bowel or hormonal function beyond 12 months or in in other domains of health-related quality-of-life measures. These findings may facilitate counseling regarding the comparative harms of contemporary treatments for prostate cancer.

Using canonical correlation analysis to identify environmental attitude groups: considerations for national forest planning in the southwestern U.S.

As public land management agencies pursue region-specific resource management plans, with meaningful consideration of public attitudes and values, there is a need to characterize the complex mix of environmental attitudes in a diverse population. The contribution of this investigation is to make use of a unique household, mail/internet survey data set collected in 2007 in the Southwestern United States (Region 3 of the U.S. Forest Service). With over 5,800 survey responses to a set of 25 Public Land Value statements, canonical correlation analysis is able to identify 7 statistically distinct environmental attitudinal groups. We also examine the effect of expected changes in regional demographics on overall environmental attitudes, which may help guide in the development of socially acceptable long-term forest management policies. Results show significant support for conservationist management policies and passive environmental values, as well as a greater role for stakeholder groups in generating consensus for current and future forest management policies.

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

BACKGROUND: Whether prostate cancer severity modifies patient-reported functional outcomes after radical prostatectomy (RP) or external beam radiotherapy (EBRT) for localized cancer is unknown. OBJECTIVE: The 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 PARTICIPANTS: The 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 ANALYSIS: Patient-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 LIMITATIONS: Low-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. CONCLUSIONS: For 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 SUMMARY: In 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.

Comparison of Patient-reported Outcomes After External Beam Radiation Therapy and Combined External Beam With Low-dose-rate Brachytherapy Boost in Men With Localized Prostate Cancer.

PURPOSE: To compare patient-reported disease-specific functional outcomes after external beam radiation therapy (EBRT) and EBRT combined with low-dose-rate brachytherapy prostate boost (EB-LDR) among men with localized prostate cancer. METHODS AND MATERIALS: The prospective, population-based Comparative Effectiveness Analysis of Surgery and Radiation study enrolled men with localized prostate cancer in 2011 to 2012. The 26-item Expanded Prostate Cancer Index Composite measured patient-reported disease-specific function at baseline and at 6, 12, and 36 months. Higher domain scores indicate better function. Minimal clinically important difference was defined as 6 for urinary incontinence, 5 for urinary irritative function, 4 for bowel function, 12 for sexual function, and 4 for hormonal function. Multivariable linear and logistic regression models were fit to estimate the effect of treatment on patient-reported outcomes. RESULTS: Five-hundred seventy-eight men received EBRT and 109 received EB-LDR. Median patient age was 69 years, and 70% had intermediate- or high-risk disease. Men in the EB-LDR group were younger (P < .001) and less likely to receive androgen deprivation therapy (P < .001). Baseline urinary, bowel, sexual, and hormonal function was similar between treatment groups (P > .05). On multivariable analyses, men receiving EB-LDR reported worse urinary irritative function at 6 months (adjusted mean difference [AMD] -14.4, P < .001), 12 months (AMD -12.9, P < .001), and 36 months (AMD -4.7, P = .034) than men receiving EBRT. At 12 months, men receiving EB-LDR reported worse bowel function (AMD -5.8, P = .002), but these differences were not seen at 36 months. There were no significant differences in sexual or hormone function between treatment groups. CONCLUSIONS: Men treated with EB-LDR report worse bowel function at 1 year and worse urinary irritative function through 3 years compared with men treated with EBRT alone. These side effect profiles should be discussed with patients when considering EB-LDR versus EBRT treatment.

Contemporary prostate cancer radiation therapy in the United States: Patterns of care and compliance with quality measures.

PURPOSE: Quality measures represent the standards of appropriate treatment agreed upon by experts in the field and often supported by data. The extent to which providers in the community adhere to quality measures in radiation therapy (RT) is unknown. METHODS AND MATERIALS: The Comparative Effectiveness Analysis of Surgery and Radiation study enrolled men with clinically localized prostate cancer in 2011 and 2012. Patients completed surveys and medical records were reviewed. Patients were risk-stratified according to D'Amico classification criteria. Patterns of care and compliance with 8 quality measures as endorsed by national consortia as of 2011 were assessed. RESULTS: Overall, 926 men underwent definitive RT (69% external beam radiation therapy [EBRT]), 17% brachytherapy (BT), and 14% combined EBRT and BT with considerable variation in radiation techniques across risk groups. Most men who received EBRT had dose-escalated EBRT (>75 Gy; 93%) delivered with conventional fractionation (<2 Gy; 95%), intensity modulated RT (76%), and image guided RT (85%). Most men treated with BT received I125 (77%). Overall, 73% of the men received EBRT that was compliant with the quality measures (dose-escalation, image-guidance, appropriate use of androgen deprivation therapy, and appropriate treatment target) but only 60% of men received BT that was compliant with quality measures (postimplant dosimetry and appropriate dose). African-American men (64%) and other minorities (62%) were less likely than white men (77%) to receive EBRT that was compliant with quality measures. CONCLUSIONS: Most men who received RT for localized prostate cancer were treated with an appropriately high dose and received image guidance and intensity modulated RT. However, compliance with some nationally recognized quality measures was relatively low and varied by race. There are significant opportunities to improve the delivery of RT and especially for men of a minority race.

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

BACKGROUND: Despite the paramount importance of patient-reported outcomes, little is known about the evolution of patient-reported urinary and sexual function over time. OBJECTIVE: To 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 PARTICIPANTS: Patients 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 ANALYSIS: We performed multivariable logistic and linear regression analysis to investigate differences in pretreatment function between studies. RESULTS AND LIMITATIONS: The 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. CONCLUSIONS: Reporting 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 SUMMARY: Patient 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.