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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2017-08-12
NCT00004124Uploaded 12-19-2019
Access via NCI by Request
PDS UID: nci-data-395
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy
Provider Information
Provider Data DescriptionThe NCT00004124-D2 Dataset will allow users to reproduce the toxicity results reported in the Journal of Clinical Oncology (Hussain et al., JCO, 2015, PMID referenced above) for trial NCT00004124.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: bicalutamide
Drug: goserelin
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug(s)Drug: bicalutamide
Drug: goserelin
Drug: mitoxantrone hydrochloride
Drug: prednisone
Total Enrolled983
RandomizationRandomized
Blinding MethodNone
Arms Interventionbicalutamide, goserelin - Active Comparator
bicalutamide, goserelin, mitoxantrone, prednisone - Experimental
Secondary IDS9921
PubMed (PMID)18349405
29624463
21502546
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Region(s)United States
Age Range18 Years to 120 Years (ADULT, OLDER_ADULT)
Files: NCT00004124-D2
Data DictionaryNCT00004124-D2-Data-Dictionary_2.pdf
DATANCT00004124-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00004124-D1
Data DictionaryNCT00004124-D1-Data-Dictionary_2.pdf
DATANCT00004124-D1-Dataset_2.csv
OTHERREADME.pdf
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