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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2021-05-18
NCT01809691Uploaded 11-04-2023
Access via NCI by Request
PDS UID: nci-data-528
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer
Provider Information
Provider Data DescriptionThere are two dataset submissions associated with this publication: NCT01809691-D1 and NCT01809691-D2. These datasets contain the results reported in the Journal of Clinical Oncology (Agarwal et al., Journal of Clinical Oncology, 2022). This clinical dataset contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information. It also contains assessment data.
SponsorSWOG Cancer Research Network
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
ConditionsProstate Cancer
Intervention TypeDrug: TAK-700
Drug: Bicalutamide
Drug(s)Drug: TAK-700
Drug: Bicalutamide
Total Enrolled1313
RandomizationRandomized
Blinding MethodNone
Arms InterventionADT + TAK-700 - Experimental
ADT + Bicalutamide - Active Comparator
Secondary IDSWOG-S1216
PubMed (PMID)35446628
Collaborator(s)Millennium Pharmaceuticals, Inc.
National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01809691-D1
Data DictionaryNCT01809691-D1-Data-Dictionary_0.pdf
DATANCT01809691-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01809691-D2
Data DictionaryNCT01809691-D2-Data-Dictionary_0.pdf
DATANCT01809691-D2-Dataset_0.csv
OTHERREADME.pdf
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