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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00388804 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
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Prostate Cancer |
Procedure: Radiation Therapy Drug: Bicalutamide Drug: Leuprolide Drug: Goserelin Drug: Flutamide Behavioral: Questionnaire |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial of External Beam Radiation With or Without Short-Course Hormonal Therapy in Intermediate Risk Prostate Cancer Patients |
Estimated Enrollment: | 340 |
Study Start Date: | February 2005 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Radiation Therapy
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Procedure: Radiation Therapy
Radiation treatment given over about 8 1/2 weeks.
Behavioral: Questionnaire
Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
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2: Active Comparator
Radiation Therapy + Hormone Therapy (Bicalutamide/Flutamide + Leuprolide or Goserelin)
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Procedure: Radiation Therapy
Radiation treatment given over about 8 1/2 weeks.
Drug: Bicalutamide
50 mg By Mouth (PO) Daily
Drug: Leuprolide
22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month
Drug: Goserelin
10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month
Drug: Flutamide
250 mg PO Three Times Daily On the First 21-30 Days. May be used instead of Bicalutamide.
Behavioral: Questionnaire
Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
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Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew K. Lee, MD | 713-792-5906 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Andrew K. Lee, MD |
Principal Investigator: | Andrew K. Lee, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Andrew K. Lee, MD/Associate Professor ) |
Study ID Numbers: | 2003-0819 |
Study First Received: | October 15, 2006 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00388804 |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer External Beam Radiotherapy Radiation Therapy Hormone Therapy Bicalutamide Casodex |
Leuprolide Lupron Goserelin Zoladex Flutamide EBRT |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Goserelin Bicalutamide |
Urogenital Neoplasms Flutamide Genital Diseases, Male Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents |