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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2018-11-02
NCT01949337Uploaded 08-24-2024
Access via NCI by Request
PDS UID: nci-data-551
Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset contains data for the baseline characteristics table, primary analysis and secondary analyses minus adverse event and PK analyses. Three other datasets for PMID 36996380 contain adverse event and PK data.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.
ConditionsAdenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Intervention TypeDrug: enzalutamide
Drug: abiraterone
Drug: prednisone
Drug(s)Drug: enzalutamide
Drug: abiraterone
Drug: prednisone
Total Enrolled1311
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A: (enzalutamide) - Experimental
Arm B: (enzalutamide, abiraterone, prednisone) - Experimental
Secondary IDU10CA031946
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Medivation, Inc.
Biologics, Inc.
Region(s)United States
Canada
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01949337-D1
Data DictionaryNCT01949337-D1-Data-Dictionary.pdf
DATANCT01949337-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT01949337-D2
Data DictionaryNCT01949337-D2-Data-Dictionary.pdf
DATANCT01949337-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT01949337-D3
Data DictionaryNCT01949337-D3-Data-Dictionary.pdf
DATANCT01949337-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT01949337-D4
Data DictionaryNCT01949337-D4-Data-Dictionary.pdf
DATANCT01949337-D4-Dataset.csv
OTHERREADME.pdf
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