Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage II or Stage III Prostate Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the prostate
• * Clinical stage T1c-3b, N0-X, M0
• * Gleason score ≥ 6
• Planning to undergo pelvic lymphadenectomy and radical prostatectomy at Mayo Clinic Rochester
• * Interval from biopsy to prostatectomy is at least 4, but no more than 14, weeks
• * Selected patients of Dr. R. P. Myers who are undergoing prostatectomy during the enrollment period will be assigned to the control group\* NOTE: \*Additional historical controls may be selected from Dr. Myers' patients who underwent prostatectomy within the past 4 years
• PATIENT CHARACTERISTICS:
• Age
• 40 and over
• Performance status
• ECOG 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Not specified
• Hepatic
• ALT normal (10-45 U/L)
• AST normal (12-31 U/L)
• Alkaline phosphatase normal (119-309 U/L)
• Bilirubin normal (0.1-1.0 mg/dL)
• No history of hepatitis, cirrhosis, or other hepatic dysfunction
• Renal
• Creatinine \< 1.5 mg/dL
• Other
• Fertile patients must use effective contraception
• No hypersensitivity to sulindac (treatment group)
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent immunotherapy
• Chemotherapy
• No other concurrent chemotherapy
• Endocrine therapy
• No prior ablation (treatment group)
• No prior hormone replacement or antiandrogen therapy (e.g., testosterone, diethylstilbestrol, leuprolide, goserelin, flutamide, bicalutamide, finasteride, nilutamide, or megestrol)
• No concurrent antiandrogen therapy, luteinizing hormone-releasing hormone agonists, finasteride, or diethylstilbestrol
• Radiotherapy
• No prior pelvic radiotherapy
• No concurrent radiotherapy
• Surgery
• See Disease Characteristics
• Other
• No prior treatment for prostate cancer before prostatectomy (control group)
• No concurrent cyclooxygenase-2 inhibitors
• No concurrent sulindac
• No concurrent nonsteroidal anti-inflammatory drugs except low-dose (no more than 325 mg/day) aspirin for cardiovascular prophylaxis