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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
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4200
Study Start Date: March 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326286

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Louisiana
Lousiana State University Health Sciences Center- New Orleans
New Orleans, Louisiana, United States, 70112
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Vanderbilt University
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
Investigators
Principal Investigator: David F Penson, MD, MPH Vanderbilt University
  More Information

No publications provided

Responsible Party: David Penson, Professor of Urologic Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01326286     History of Changes
Other Study ID Numbers: 110299, 1R01HS019356-01
Study First Received: March 25, 2011
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Comparative Effectiveness Research
Prostatectomy
radiotherapy
quality of life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014