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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2011-01
NCT00626548Uploaded 04-28-2020
Available for Download
PDS UID: Prostat_Multipl_2008_406
Enhancing the Analytic Capacity of Prostat_AstraZe_2008_103 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis 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_2008_103, 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. An optional sixth linkage criterion, BMI category, is also provided so that data users can further filter the set of many-to-many linkages to stronger matches. 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 dataset677
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/g0gb-zn20
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryEnthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases. All patients participating in this clinical trial will receive existing 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: Palcebo
Drug(s)Drug: Palcebo
Drug: ZD4054
Total Enrolled2577
RandomizationRandomized
Blinding MethodTriple
Arms InterventionPlacebo - Placebo Comparator
ZD4054 - Experimental
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Czech Republic
Denmark
Finland
France
Germany
Hungary
India
Ireland
Israel
Italy
Japan
Korea, Republic of
Latvia
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
Turkey
United Kingdom
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLLinked Prostate_AstraZe_2008_103 Documentation.docx
CRFDataset Contents and Variable Crosswalk.xlsx
DATA DICTIONARYCODEBOOK_linked_prostate103.pdf
DATA SUMMARYProc Contents Data Dictionary Linked_Prostat_AstraZe_2008_103.pdf
DATA SUMMARYDescriptive_Stats_Linked_Prostat_AstraZe_2008_103.xlsx
DATA (COMPARATOR ARM)linked_prostate103.sas7bdat
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