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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
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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-31
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients840RandomizationYesPubMed (PMID)28146658.00ClinicalTrial.gov IDNCT00002874ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00002874
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeDrug, Radiation, PlaceboDataset TypeOther

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):

Available Downloads:

To gain access to the data and analytic tools click here.

DATA DICTIONARY: NCT00002874-D1-Data-Dictionary.pdf

DATA: NCT00002874-D1-Dataset.csv

OTHER: README.pdf