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Prostate

A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
Unique Dataset IDnci-data-31DownloadableNo
NCI Description
This dataset will allow users to reproduce the treatment comparison in trial NCT00002874.
Clinical Trial Title
A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
Trial Summary and Conditions
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
Data Summary
See data dictionary for more details.
Study Objectives
N/A
Outcome Measures
Primary: Overall Survival (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Secondary: Non-Prostate Cancer Death (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Second PSA Recurrence (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Third PSA Recurrence (12-year Rates Reported) [ Time Frame: From start of salvage hormone therapy to 12 years. ] PSA Complete Response at End of Protocol Treatment [ Time Frame: End of protocol treatment, which is planned to last for two years ] Distant Failure (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Prostate Cancer Death (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Progression-free Survival (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Grade 3+ Toxicity [ Time Frame: From date of randomization to four years. ]
ClinicalTrial.gov
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
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DATA DICTIONARY: NCT00002874-D1-Data-Dictionary.pdf

DATA: NCT00002874-D1-Dataset.csv

OTHER: README.pdf