Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.

Detailed Description
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OBJECTIVES: Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer. Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients. OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV). Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid. Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy. Hormonal therapy is administered until 9 months of treatment have elapsed. Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter. PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.

Official Title
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Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: flutamide
* Drug: leuprolide acetate
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven localized adenocarcinoma of the prostate Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4 CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50 Negative pelvic lymphadenectomy, if PSA is greater than 50 Bone scan negative for metastases or PSA no greater than 20 PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 70,000/mm3 Hemoglobin at least 10 g/dL Patients on anticoagulant therapy must have a baseline PT test Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) ALT or AST less than 1.5 times ULN Alkaline phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.5 times ULN Cardiovascular: No history of collagen vascular disease Other: No acute infection requiring antibiotics No history of hypersensitivity to flutamide No history of hypersensitivity to leuprolide acetate PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: flutamide|nan|
|Drug: leuprolide acetate|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer