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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2010-07
NCT00554229Uploaded 06-09-2020
Available for Download
PDS UID: Prostat_Multipl_2009_417
Enhancing the Analytic Capacity of Prostat_AstraZe_2009_144 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Prostat_AstraZe_2009_144, were matched with prostate cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset266
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wqb5-8m69
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryEnthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. * This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. * ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases. * All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy. * Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. * No patients will be deprived of standard prostate cancer therapy.
ConditionsProstate Cancer
Intervention TypeDrug: ZD4054
Drug: Placebo
Drug(s)Drug: ZD4054
Drug: Placebo
Total Enrolled896
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionZD4054 - Experimental
Placebo - Placebo Comparator
Secondary ID2007-003227-20
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
Finland
France
Germany
Hong Kong
Hungary
India
Italy
Japan
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Russian Federation
Serbia
Singapore
South Africa
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLLinked Prostate_AstraZe_2009_144 Documentation.docx
CRFDataset Contents and Variable Crosswalk.xlsx
DATA DICTIONARYCODEBOOK_linked_prostate144.pdf
DATA SUMMARYProc Contents Data Dictionary Linked_Prostate144.pdf
DATA SUMMARYDescriptive_Stats_Linked_Prostat_AstraZe_2009_144.xlsx
DATA (COMPARATOR ARM)linked_prostate144.sas7bdat
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