|Phase III||Treatment||Completed||Any age||NCI, Other||CDR0000063821|
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
Further Study Information
OBJECTIVES: I. Compare the overall and disease-specific survival and local and/or distant clinical relapse rate in patients with locally confined carcinoma of the prostate treated with goserelin plus flutamide used as cytoreductive agents prior to definitive radiotherapy vs radiotherapy alone. II. Compare these regimens in terms of freedom from PSA failure, second clinical relapse, and second PSA relapse in these patients. III. Compare prostate rebiopsy results in these patients at 2 years. IV. Determine the effect of goserelin and flutamide therapy on sexual function in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by PSA level (less than 4 vs 4-20), tumor differentiation (good vs moderate vs poor), nodal status (N0 vs Nx), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks, or once as a time release injection (intramuscular leuprolide may be substituted for goserelin), beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks. Arm II: Patients undergo radiotherapy only, as in arm I. Patients are followed every 3 months for the remainder of the first year, every 4 months for 1 year, every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1980 patients will be accrued for this study within 5 years.
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1b/1c/2a/2b, Nx or N0, M0 disease (stage I or II) Nodes considered negative by imaging methods classified as Nx; those considered negative by surgical sampling classified as N0 PSA no greater than 20
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: ALT no greater than 2 times upper limit of normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent compliance No other malignancy in the past 5 years except basal or squamous cell skin carcinoma (a minimum of 2 years since squamous cell carcinoma)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 60 days since prior finasteride for prostate hypertrophy At least 90 days since prior testosterone No other prior hormonal therapy Radiotherapy: No prior radiotherapy Surgery: No prior radical surgery or cryosurgery for carcinoma of the prostate
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology GroupNational Cancer Institute
|David G. McGowan, MD||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002597
Information obtained from ClinicalTrials.gov on November 20, 2012
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