Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
April 2010
NCT00004054Uploaded 11-15-2017
Access via NCI by Request
PDS UID: nci-data-346
A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset contains data from trial NCT00004054 to reproduce the results in 26209502.
SponsorRadiation Therapy 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. Radiation therapy uses high-energy x-rays to damage tumor cells. 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 radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: bicalutamide
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: flutamide
Drug: paclitaxel
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Radiation: Radiation therapy
Drug: warfarin
Drug(s)Drug: bicalutamide
Drug: flutamide
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: paclitaxel
Drug: warfarin
Total Enrolled397
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionHormones and RT - Experimental
Hormones and RT plus Chemotherapy - Experimental
Secondary IDCDR0000067250
PubMed (PMID)18990504
26209502
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00004054-D1
Data DictionaryNCT00004054-D1-Data-Dictionary.pdf
DATANCT00004054-D1-Dataset.csv
OTHERREADME.pdf
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use