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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as exisulind, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant exisulind works in treating patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Sulindac; Sulindac sulfone

Criteria

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