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.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer stage I prostate cancer adenocarcinoma of the prostate	Procedure: radiation therapy  Procedure: hormone therapy  Procedure: endocrine therapy  Procedure: antiandrogen therapy  Procedure: releasing factor agonist therapy  Drug: flutamide  Drug: leuprolide	Phase II

Further Study Details: 

OBJECTIVES: I. Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer. II. Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients.

PROTOCOL 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.

Genders Eligible for Study:  Male

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

Not specified

--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

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Ronald D. Ennis,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000065883; CPMC-IRB-7947; NCI-G97-1356
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003124
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08