Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer (CEASAR)
Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90033
- University of Southern California
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San Francisco, California, Forente stater, 94143
- University of California, San Francisco
-
-
Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University
-
-
Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Lousiana State University Health Sciences Center- New Orleans
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08903
- Cancer Institute of New Jersey
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-Specific Health-Related Quality of Life (EPIC)
Tidsramme: 12, 24 and 60 months after enrollment
|
Sexual, urinary, bowel and hormonal function and bother subscores will be assessed
|
12, 24 and 60 months after enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
cancer-free survival
Tidsramme: 6 and 12 months after enrollment
|
assessed using PSA levels obtained from medical record review
|
6 and 12 months after enrollment
|
|
Complications of treatment
Tidsramme: 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)
Tidsramme: 6- and 12-months after enrollment
|
6- and 12-months after enrollment
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: David F Penson, MD, MPH, Vanderbilt University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 110299
- 1R01HS019356-01 (U.S.A. AHRQ-stipend/kontrakt)
- CE grant (Annen identifikator: PCORI)
- 1R01HS022640-01 (U.S.A. AHRQ-stipend/kontrakt)
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