Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer (CEASAR)
Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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California
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Los Angeles, California, Vereinigte Staaten, 90033
- University of Southern California
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San Francisco, California, Vereinigte Staaten, 94143
- University of California, San Francisco
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Emory University
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Lousiana State University Health Sciences Center- New Orleans
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New Jersey
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New Brunswick, New Jersey, Vereinigte Staaten, 08903
- Cancer Institute of New Jersey
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Open Radical Prostatectomy
262
|
|
Robotic Radical Prostatectomy
1303
|
|
Intensity-Modulated Radiotherapy
638
|
|
Interstitial Brachytherapy
171
|
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combined EBRT and Brachytherapy
143
|
|
Active Surveillance
448
|
|
Various other treatments
300
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Disease-Specific Health-Related Quality of Life (EPIC)
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
cancer-free survival
Zeitfenster: 6 and 12 months after enrollment
|
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
Zeitfenster: 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)
Zeitfenster: 6- and 12-months after enrollment
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6- and 12-months after enrollment
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: David F Penson, MD, MPH, Vanderbilt University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 110299
- 1R01HS019356-01 (US-AHRQ-Zuschuss/Vertrag)
- CE grant (Andere Kennung: PCORI)
- 1R01HS022640-01 (US-AHRQ-Zuschuss/Vertrag)
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