Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer

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.

Inclusion Criteria:

- Pathologic diagnosis of adenocarcinoma of the prostate

- Clinically localized stage

- PSA <50ng/ml

- age 18-79

Exclusion Criteria:

- diagnosis of other malignancy (excluding squamous or basal cell carcinoma of the skin)
within 3 years of diagnosis of prostate cancer

- age 80 or greater

- clinically locally advanced or metastatic disease

- PSA equal to or greater than 50 ng/ml

- pathologic diagnosis of prostate cancer greater than 6 months prior to baseline
recruitment interview