Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
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.
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.
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