Prostate Cancer (PCa) is the most common solid tumor among American men and the second leading cause of cancer death. Surgery, radiation and active surveillance (AS) may all be appropriate treatments for men newly diagnosed with localized PCa. The 2008 AHRQ comparative effectiveness report on therapies for localized PCa determined that "no one therapy can be considered the preferred treatment due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects." Simply put, there is a pressing need for additional and better studies on the comparative effectiveness of treatments for localized PCa. In 2010, AHRQ funded the Comparative Effectiveness Analysis of Surgery And Radiation for localized PCa (CEASAR) study. CEASAR consists of a prospective, population-based cohort of 3691 men diagnosed with localized PCa in 2011 who were treated with contemporary therapies, including AS. CEASAR collected baseline patient-reported health-related quality of life, clinical, and sociodemographic data. We then obtained clinical and patient reported outcomes at 6 and 12 months after enrollment. We also performed medical record review at 1 year, collecting clinical information and data on the technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators. We will leverage the existing CEASAR study and collect 3- and 5-year follow-up data to: (1) Compare the effectiveness and harms of contemporary surgery, radiation and AS in terms of 3- and 5-year patient-reported outcomes and cancer control. We will identify and analyze outcome "profiles" associated with each therapy that can be used to inform patient specific outcome trajectories when selecting therapy and after treatment. (2) Identify patient-level characteristics that influence the comparative effectiveness and harms of treatment. We will assess the influence of race, co-morbid conditions and socio-economic status on 3- and 5- year patient-reported outcomes in the entire group and in individual treatment groups to identify subgroups of patients who respond uniquely to certain treatments. (3) To evaluate the association of quality of care with clinical and patient-reported outcomes. We will assess the relationship between pre-specified quality indicators and 3- and 5-year outcomes in CEASAR. We will then re-assess the comparative effectiveness of the various treatments, controlling for quality measures found to independently influence outcomes. By understanding what works, in which patients and in whose hands in localized prostate cancer, we will be advancing AHRQ's mission of improving the quality, safety and effectiveness of healthcare in this common condition.

Public Health Relevance

This study compares the effectiveness of commonly used modern therapies (including surgery, radiation and active surveillance) for the treatment of localized prostate cancer, the most common solid tumor among American men. As all therapies have differing effects of cancer control and quality of life, men newly diagnosed with this condition will be able to use the information gathered in this study to make more informed and personal decisions about the best way to treat their cancer.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
1R01HS022640-01
Application #
8639188
Study Section
Health Care Quality and Effectiveness Research (HQER)
Program Officer
Lawrence, William
Project Start
2013-09-30
Project End
2018-09-29
Budget Start
2013-09-30
Budget End
2018-09-29
Support Year
1
Fiscal Year
2013
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Surgery
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212