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Spots Global Cancer Trial Database for Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

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Trial Identification

Brief Title: Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

Official Title: A PHASE III TRIAL OF THE USE OF LONG TERM TOTAL ANDROGEN SUPPRESSION FOLLOWING NEOADJUVANT HORMONAL CYTOREDUCTION AND RADIOTHERAPY IN LOCALLY ADVANCED CARCINOMA OF THE PROSTATE

Study ID: NCT00767286

Conditions

Prostate Cancer

Study Description

Brief Summary: RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Detailed Description: OBJECTIVES: I. Compare locoregional control, disease-free survival, and overall survival in patients with carcinoma of the prostate who are considered at high risk of relapse and receive long-term adjuvant zoladex (ZDX) vs. no adjuvant treatment following neoadjuvant ZDX/flutamide and radiotherapy. II. Compare sexual function in patients treated with these two regimens. OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy and Releasing Factor Agonist Therapy plus Radiotherapy. Flutamide, FLUT, NSC-147834; and Zoladex, ZDX, NSC-606864; plus external-beam irradiation using megavoltage equipment with energies of at least 4 MV (at least 6 MV preferred). Arm II: Neoadjuvant Antiandrogen Therapy and Releasing Factor Agonist Therapy plus Radiotherapy followed by Adjuvant Releasing Factor Agonist Therapy. FLUT; and ZDX; plus external-beam irradiation using equipment as in Arm I; followed by ZDX. PROJECTED ACCRUAL: 1,508 patients will be accrued over 2 years.

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

Name: Gerald E. Hanks, MD

Affiliation: Fox Chase Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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