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

24 septembre 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Cancer de la prostate

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

3265

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 79 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Disease-Specific Health-Related Quality of Life (EPIC) Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
cancer-free survival Délai: 6 and 12 months after enrollment	assessed using PSA levels obtained from medical record review	6 and 12 months after enrollment
Complications of treatment Délai: 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) Délai: 6- and 12-months after enrollment		6- and 12-months after enrollment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vanderbilt University

Collaborateurs

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

Les enquêteurs

Chercheur principal: David F Penson, MD, MPH, Vanderbilt University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2011

Achèvement primaire (Réel)

1 août 2017

Achèvement de l'étude (Réel)

1 septembre 2018

Dates d'inscription aux études

Première soumission

25 mars 2011

Première soumission répondant aux critères de contrôle qualité

29 mars 2011

Première publication (Estimation)

30 mars 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 septembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 septembre 2018

Dernière vérification