The available literature regarding comparative effectiveness and comparative harms of management options for localized prostate cancer is inadequate to power a shared decision-making process between patients and providers. The few randomized trials that exist are flawed in important ways, leaving enormous uncertainty about how best to manage newly diagnosed prostate cancer, and possible trade-offs between side-effects and efficacy of surgery, radiation and active surveillance. A well-executed long-term, population-based study that assesses real-world outcomes in a diverse cohort would add considerably to the literature and could overcome some of the limitations of earlier randomized clinical trials. The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) cohort is a population-based cohort study of approximately 3000 men (over 25% non-white) with localized prostate cancer, accrued in 2011-12. Longitudinal patient-reported data have been collected out to 5 years, and a medical chart review was performed 12 months after diagnosis. This cohort provides an invaluable opportunity to study comparative long-term oncologic and quality of life outcomes. In addition, its diversity and breadth make in an ideal cohort in which to study the influence of patient characteristics, such as baseline disease risk stratum, race, age and comorbidity, on these downstream outcomes.
The Specific Aims are to: 1. Compare the clinical outcomes of surgery, radiation and active surveillance (cancer outcomes and complications). 2. Compare patient-reported outcomes of these management options with respect to disease-specific and general quality of life outcomes, financial toxicity, and qualitative outcomes 3. Explore the influence of baseline patient characteristics on the oncologic and quality of life outcomes. In order to accomplish these Aims, we will perform a patient survey and medical chart review 10 years after diagnosis, and we will perform structured qualitative research interviews with a sub-set of patients. The proposed study draws on the experience of the CEASAR investigators who have collaborated successfully since 2009 on the planning and execution of several rounds of data collection, analysis and publication. The results of this study will be utilized to inform the shared decision-making process, in order to improve concordance between treatment decisions and patient preferences and priorities.

Public Health Relevance

Men diagnosed with prostate cancer have to choose a management option (most commonly surgery, radiation or active surveillance), even though the available literature regarding comparative effectiveness and comparative harms of these management options is inadequate. Our aim is to expand upon an established population-based cohort of approximately 3,000 men diagnosed with localized prostate cancer between 2011 and 2012, by collecting 10-year clinical and patient-reported information. This will enable comparisons of oncologic outcomes and quality of life outcomes among the treatment options, thereby providing information to power shared-decision making processes between patients and their providers.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Health Services Organization and Delivery Study Section (HSOD)
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Jensen, Roxanne Elaine
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Vanderbilt University Medical Center
United States
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