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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 3265

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Lousiana State University Health Sciences Center- New Orleans
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
Open Radical Prostatectomy; 262
Robotic Radical Prostatectomy; 1303
Intensity-Modulated Radiotherapy; 638
Interstitial Brachytherapy; 171
combined EBRT and Brachytherapy; 143
Active Surveillance; 448
Various other treatments; 300

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Specific Health-Related Quality of Life (EPIC)	Sexual, urinary, bowel and hormonal function and bother subscores will be assessed	12, 24 and 60 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cancer-free survival	assessed using PSA levels obtained from medical record review	6 and 12 months after enrollment
Complications of treatment	data collected from patient report and medical record review	6- and 12-months after enrollment
General Health-Related Quality of Life (SF-12)		6- and 12-months after enrollment

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: Patient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; Emory University; University of Southern California; University of California, San Francisco; University of California, Irvine; University of Utah; Louisiana State University Health Sciences Center in New Orleans; Agency for Healthcare Research and Quality (AHRQ); Rutgers Cancer Institute of New Jersey
• Investigators: Principal Investigator: David F Penson, MD, MPH, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 25, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; radiotherapy; Prostatectomy; Comparative Effectiveness Research
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 110299; 1R01HS019356-01 (U.S. AHRQ Grant/Contract); CE grant (Other Identifier: PCORI); 1R01HS022640-01 (U.S. AHRQ Grant/Contract)