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

24 september 2018 bijgewerkt door: David Penson, Vanderbilt University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Prostaatkanker

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

3265

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 79 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Disease-Specific Health-Related Quality of Life (EPIC) Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
cancer-free survival Tijdsspanne: 6 and 12 months after enrollment	assessed using PSA levels obtained from medical record review	6 and 12 months after enrollment
Complications of treatment Tijdsspanne: 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) Tijdsspanne: 6- and 12-months after enrollment		6- and 12-months after enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University

Medewerkers

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

Onderzoekers

Hoofdonderzoeker: David F Penson, MD, MPH, Vanderbilt University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2011

Primaire voltooiing (Werkelijk)

1 augustus 2017

Studie voltooiing (Werkelijk)

1 september 2018

Studieregistratiedata

Eerst ingediend

25 maart 2011

Eerst ingediend dat voldeed aan de QC-criteria

29 maart 2011

Eerst geplaatst (Schatting)

30 maart 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 september 2018

Laatste update ingediend die voldeed aan QC-criteria

24 september 2018

Laatst geverifieerd