IMPORTANCEPatients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects.OBJECTIVE To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance. DESIGN, SETTING, AND PARTICIPANTSPopulation-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015.EXPOSURES Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance. MAIN OUTCOMES AND MEASURESQuality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point. RESULTSOf 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI,.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI,) and brachytherapy (20.5 [95% CI,.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains.CONCLUSIONS AND RELEVANCE In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.

Purpose: To evaluate the reliability and validity of six PROMIS measures (anxiety, depression, fatigue, pain interference, physical function, sleep disturbance) telephone-administered to a diverse, population-based cohort of localized prostate cancer patients. Methods: Newly-diagnosed men were enrolled in the North Carolina Prostate cancer Comparative Effectiveness and Survivorship Study. PROMIS measures were telephone-administered pre-treatment (baseline), and at 3-months and 12-months post-treatment initiation (N=778). Reliability was evaluated using Cronbach’s alpha. Dimensionality was examined with bifactor models and explained common variance (ECV). Ordinal logistic regression models were used to detect potential differential item functioning (DIF) for key demographic groups. Convergent and discriminant validity were assessed by correlations with the legacy instruments Memorial Anxiety Scale for Prostate Cancer and SF-12v2. Known-groups validity was examined by age, race/ethnicity, comorbidity, and treatment. Results: Each PROMIS measure had high Cronbach’s alpha values (0.86 to 0.96) and was sufficiently unidimensional. Floor effects were observed for anxiety, depression, and pain interference measures; ceiling effects were observed for physical function. No DIF was detected. Convergent validity was established with moderate to strong correlations between PROMIS and legacy measures (0.41 to 0.77) of similar constructs. Discriminant validity was demonstrated with weak correlations between measures of dissimilar domains (−0.20 to −0.31). PROMIS measures detected differences across age, race/ethnicity, and comorbidity groups; no differences were found by treatment. Conclusions: This study provides support for the reliability and construct validity of six PROMIS measures in prostate cancer, as well as the utility of telephone administration for assessing HRQoL in low literacy and hard-to-reach populations.

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

Overall, patient reporting provides information similar to medical record abstraction without significant differences by patient race or educational level. Use of patient reports, which are less costly than medical record audits, is a reasonable approach for observational comparative effectiveness research.

Background Prostate cancer racial disparities in mortality outcomes are the largest in all of oncology, and less aggressive treatment received by African American (AA) patients versus white patients is likely a contributing factor. However, the reasons underlying the differences in treatment are unclear. Methods This study examined a prospective, population‐based cohort of 1170 men with newly diagnosed nonmetastatic prostate cancer enrolled from 2011 to 2013 before treatment throughout North Carolina. By phone survey, each participant was asked to rate the aggressiveness of his cancer, and his response was compared to the actual diagnosis based on a medical record review. Participants were also asked to rate the importance of 10 factors for their treatment decision‐making process. Results Among AA and white patients with low‐risk cancer (according to National Comprehensive Cancer Network guidelines), 78% to 80% perceived their cancers to be “not very aggressive.” However, among high‐risk patients, 54% of AA patients considered their cancers to be “not very aggressive,” whereas 24% of white patients did (P < .001). Although both AA and white patients indicated that a cure was a very important decision‐making factor, AAs were significantly more likely to consider cost, treatment time, and recovery time as very important. In a multivariable analysis, perceived cancer aggressiveness and cure as the most important factor were significantly associated with receiving any aggressive treatment and were associated with surgery (vs radiation). After adjustments for these factors and sociodemographic factors, race was not significantly associated with the treatment received. Conclusions Racial differences in perceived cancer aggressiveness and factors important in treatment decision making provide novel insights into reasons for the known racial disparities in prostate cancer as well as potential targets for interventions to reduce these disparities.