Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer (CEASAR)
Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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California
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Los Angeles, California, Spojené státy, 90033
- University of Southern California
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San Francisco, California, Spojené státy, 94143
- University of California, San Francisco
-
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University
-
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70112
- Lousiana State University Health Sciences Center- New Orleans
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New Jersey
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New Brunswick, New Jersey, Spojené státy, 08903
- Cancer Institute Of New Jersey
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Disease-Specific Health-Related Quality of Life (EPIC)
Časové okno: 12, 24 and 60 months after enrollment
|
Sexual, urinary, bowel and hormonal function and bother subscores will be assessed
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12, 24 and 60 months after enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
cancer-free survival
Časové okno: 6 and 12 months after enrollment
|
assessed using PSA levels obtained from medical record review
|
6 and 12 months after enrollment
|
|
Complications of treatment
Časové okno: 6- and 12-months after enrollment
|
data collected from patient report and medical record review
|
6- and 12-months after enrollment
|
|
General Health-Related Quality of Life (SF-12)
Časové okno: 6- and 12-months after enrollment
|
6- and 12-months after enrollment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: David F Penson, MD, MPH, Vanderbilt University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 110299
- 1R01HS019356-01 (Grant/smlouva AHRQ USA)
- CE grant (Jiný identifikátor: PCORI)
- 1R01HS022640-01 (Grant/smlouva AHRQ USA)
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