- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01326286
Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer (CEASAR)
Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
연구 개요
상태
정황
상세 설명
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:
- 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.
- To identify patient level characteristics that may influence comparative effectiveness.
- To assess how the comparative effectiveness of the various therapies varies by quality of care received.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90033
- University of Southern California
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San Francisco, California, 미국, 94143
- University of California, San Francisco
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Lousiana State University Health Sciences Center- New Orleans
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New Jersey
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New Brunswick, New Jersey, 미국, 08903
- Cancer Institute Of New Jersey
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Open Radical Prostatectomy
262
|
|
Robotic Radical Prostatectomy
1303
|
|
Intensity-Modulated Radiotherapy
638
|
|
Interstitial Brachytherapy
171
|
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combined EBRT and Brachytherapy
143
|
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Active Surveillance
448
|
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Various other treatments
300
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Disease-Specific Health-Related Quality of Life (EPIC)
기간: 12, 24 and 60 months after enrollment
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Sexual, urinary, bowel and hormonal function and bother subscores will be assessed
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12, 24 and 60 months after enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
cancer-free survival
기간: 6 and 12 months after enrollment
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assessed using PSA levels obtained from medical record review
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6 and 12 months after enrollment
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Complications of treatment
기간: 6- and 12-months after enrollment
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data collected from patient report and medical record review
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6- and 12-months after enrollment
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General Health-Related Quality of Life (SF-12)
기간: 6- and 12-months after enrollment
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6- and 12-months after enrollment
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: David F Penson, MD, MPH, Vanderbilt University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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