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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
April 2014
NCT00288080Uploaded 02-03-2022
Access via NCI by Request
PDS UID: nci-data-488
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset, NCT00288080-D1, contains the data presented in the RTOG-0521 primary publication (PMID: 30860948).
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: Dexamethasone
Drug: Prednisone
Drug: docetaxel
Drug: Oral antiandrogen
Radiation: Radiation therapy
Drug: LHRH agonist
Drug(s)Drug: Oral antiandrogen
Drug: LHRH agonist
Drug: Dexamethasone
Drug: Prednisone
Drug: docetaxel
Total Enrolled612
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionAndrogen suppression + Radiation Therapy - Active Comparator
Androgen suppression + Radiation Therapy + Chemotherapy - Experimental
Secondary IDCDR0000462375
PubMed (PMID)16425991
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
Region(s)United States
Canada
Age Range18 Years to 120 Years (Adult, Older Adult)
Files: NCT00288080-D1
Data DictionaryNCT00288080-D1-Data-Dictionary_3.pdf
DATANCT00288080-D1-Dataset_3.csv
OTHERREADME.pdf
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