||5R01CA230352-02 Interpret this number
||Vanderbilt University Medical Center
||10-Year Comparative Effectiveness and Harms of Treatments for Prostate Cancer
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
1. Compare the clinical outcomes of surgery, radiation and active surveillance (cancer outcomes and
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.
Development and Internal Validation of a Web-based Tool to Predict Sexual, Urinary, and Bowel Function Longitudinally After Radiation Therapy, Surgery, or Observation.
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European urology, 2020 Aug; 78(2), p. 248-255.