Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate
Prostate Cancer
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high grade prostatic intraepithelial neoplasia Confirmed by second prostate biopsy within 180 days of first biopsy No prior or concurrent prostatic carcinoma No prior hormonal replacement or antiandrogen therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 5 years Hematopoietic: Not specified Hepatic: SGOT and alkaline phosphatase no greater than 2 times upper limit of normal No hepatitis B or C or liver cirrhosis Renal: Not specified Other: Fertile patients must use effective contraception No other prior malignancy in past 5 years except carcinoma in situ or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: Not specified
Sites / Locations
- CCOP - Scottsdale Oncology Program
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Ann Arbor Regional
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Quain & Ramstad Clinic, P.C.
- CCOP - Merit Care Hospital
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinical and Medical Center
- Penn State Geisinger Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Saskatchewan Cancer Agency
Arms of the Study
Arm 1
Arm 2
Experimental
Other
flutamide
placebo
Patients receive oral flutamide once daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, at 1, 6, and 12 months, and then annually therafter. Patients are followed annually for up to 10 years.
Patients receive an oral placebo once daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, at 1, 6, and 12 months, and then annually therafter. Patients are followed annually for up to 10 years.