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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 ProstateUnique Dataset IDnci-data-345ClinicalTrial.gov IDNCT00002633
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.
See data dictionary for more details.
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.
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 ]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
This dataset will allow users to reproduce the treatment comparison between Combined Androgen-Deprivation Therapy Plus Radiotherapy and Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer in trial NCT00002633.
Available Downloads: NCT00002633-D1
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00002633-D1-Data-Dictionary.pdf