Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Flutamide

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