Clinical trial NCT01326286: Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer
Official title: Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Comparative Effectiveness Research
Prostatectomy
radiotherapy
quality of life
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Agency for Healthcare Research and Quality (AHRQ)
name: Louisiana State University Health Sciences Center in New Orleans
name: University of California, Irvine
name: University of California, San Francisco
name: University of Southern California
name: M.D. Anderson Cancer Center
name: University of Utah
name: Emory University
name: Rutgers Cancer Institute of New Jersey
First posted: 2011-03-30
Enrollment: 3265
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-Specific Health-Related Quality of Life (EPIC)
timeFrame: 12, 24 and 60 months after enrollment
Secondary outcomes:
measure: cancer-free survival
timeFrame: 6 and 12 months after enrollment
measure: Complications of treatment
timeFrame: 6- and 12-months after enrollment
measure: General Health-Related Quality of Life (SF-12)
timeFrame: 6- and 12-months after enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: New Orleans
country: United States
facility: Lousiana State University Health Sciences Center- New Orleans
state: Louisiana
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Vanderbilt University
name: David F Penson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: