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Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer

18 Years
79 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Comparative Effectiveness Study of Various Treatments 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Disease-Specific Health-Related Quality of Life (EPIC)

Outcome Description:

Sexual, urinary, bowel and hormonal function and bother subscores will be assessed

Outcome Time Frame:

12 months after enrollment

Safety Issue:


Principal Investigator

David F Penson, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • Comparative Effectiveness Research
  • Prostatectomy
  • radiotherapy
  • quality of life
  • Prostatic Neoplasms



Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of California, San FranciscoSan Francisco, California  94143
Emory UniversityAtlanta, Georgia  30322
University of Southern CaliforniaLos Angeles, California  90033
Lousiana State University Health Sciences Center- New OrleansNew Orleans, Louisiana  70112