Overview

Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Herbert Irving Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Flutamide
Leuprolide
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

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