Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This study will primarily compare the effectiveness of surgery and radiation for localized
      prostate cancer, the most common male cancer. It will focus on modern technologies and
      control for differences in patients and treatments that may affect both cancer-related and
      patient-reported outcomes (such as impotence and incontinence). By figuring out what
      treatments "work best, in which patients and in whose hands", it will help men with prostate
      cancer make better decisions regarding their care.
    

Detailed description: 
      Prostate cancer is the most common solid tumor and the second leading cause of cancer death
      among American men. While surgery, radiation and observation have all been deemed appropriate
      for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment.
      AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized
      prostate cancer concluded that "no one therapy can be considered the preferred treatment for
      localized prostate cancer 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." The existing literature is limited by its focus on older
      therapeutic modalities and failure to control for individual patient characteristics and
      provider/hospital characteristics that may influence outcomes (quality of care). To fill
      these evidence gaps, we propose to expand a network of state tumor registries and a national
      observational disease registry to establish a new population-based cohort of men newly
      diagnosed with localized prostate cancer. We will prospectively measure key patient-reported
      outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and
      6 and 12 months later. We will also collect detailed medical record information, including
      clinical data, technical details of the interventions, complications, short-term cancer
      recurrence rates, and quality-of-care indicators.

      By using this approach, we will overcome limitations of the extant literature and achieve the
      following specific aims:

        1. To compare the effectiveness of contemporary surgical and radiation techniques for
           localized prostate cancer in the cohort described above in terms of the 6- and 12-month
           patient-reported outcomes, side-effects and complications of treatment.

        2. To identify patient level characteristics that may influence comparative effectiveness.

        3. To assess how the comparative effectiveness of the various therapies varies by quality
           of care received.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population-based sample of men diagnosed with localized prostate cancer in the states of
        Louisiana and New Jersey and the metropolitan areas of Atlanta and Los Angeles, augmented
        with a convenience sample of men enrolled in the CaPSURE database, a national observational
        disease registry.
      
Keywords: Comparative Effectiveness Research; Prostatectomy; radiotherapy; quality of life