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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:

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Prostate

Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate

Unique Data Set IDnci-data-9
DownloadableNo
SponsorNCIC Clinical Trials GroupData ProviderNCITotal Study Enrolled Patients1205RandomizationYesPubMed (PMID)25691677.00ClinicalTrial.gov IDNCT00002633ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00002633
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, Surgery, RadiationData Set TypeOther

Clinical Trial Title

Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate

Trial Summary and Conditions

RATIONALE: Hormones can stimulate the growth 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. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation. Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens. OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical [no CT scan] vs radiological [CT scan negative] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone [LHRH] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.

Outcome Measures

Primary: Overall survival [ Time Frame: 10 years ] Secondary: Disease specific survival [ Time Frame: 10 years ] Time to disease progression [ Time Frame: 10 years ] Symptomatic local control measured by surgical intervention rate [ Time Frame: 10 years ] Quality of life assessed by EORTC-QLQ-C30 + 3 and a trial-specific checklist (PR17) or the FACT-P questionnaire [ Time Frame: 10 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: NCT00002633-D1-Data-Dictionary.pdf

DATA: NCT00002633-D1-Dataset.csv

OTHER: README.pdf