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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Patient Centered Outcome Research Institute
Louisiana State University Health Sciences Center in New Orleans
University of California, Irvine
University of California, San Francisco
University of Southern California
M.D. Anderson Cancer Center
University of Utah
Emory University
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
David Penson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01326286
First received: March 25, 2011
Last updated: October 6, 2014
Last verified: October 2014

March 25, 2011
October 6, 2014
March 2011
June 2016   (final data collection date for primary outcome measure)
Disease-Specific Health-Related Quality of Life (EPIC) [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
Sexual, urinary, bowel and hormonal function and bother subscores will be assessed
Same as current
Complete list of historical versions of study NCT01326286 on ClinicalTrials.gov Archive Site
  • cancer-free survival [ Time Frame: 6 and 12 months after enrollment ] [ Designated as safety issue: No ]
    assessed using PSA levels obtained from medical record review
  • Complications of treatment [ Time Frame: 6- and 12-months after enrollment ] [ Designated as safety issue: Yes ]
    data collected from patient report and medical record review
  • General Health-Related Quality of Life (SF-12) [ Time Frame: 6- and 12-months after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer
Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer

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.

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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Prostate Cancer
Not Provided
  • Open Radical Prostatectomy
  • Robotic Radical Prostatectomy
  • Intensity-Modulated Radiotherapy
  • 3D-Conformal Beam Radiotherapy
  • Image-Guided RT (i.e., cyberknife)
  • Interstitial Brachytherapy
  • Proton-Beam Radiotherapy
  • Active Surveillance
  • Whole Gland Cryoablation of the prostate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4200
September 2018
June 2016   (final data collection date for primary outcome measure)

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
Male
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01326286
110299, 1R01HS019356-01
No
David Penson, Vanderbilt University
Vanderbilt University
  • Patient Centered Outcome Research Institute
  • Agency for Healthcare Research and Quality (AHRQ)
  • Louisiana State University Health Sciences Center in New Orleans
  • University of California, Irvine
  • University of California, San Francisco
  • University of Southern California
  • M.D. Anderson Cancer Center
  • University of Utah
  • Emory University
  • Rutgers Cancer Institute of New Jersey
Principal Investigator: David F Penson, MD, MPH Vanderbilt University
Vanderbilt University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP