Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in patients with stage II or III prostate cancer undergoing radical prostatectomy. Secondary * Determine the effect of this drug (preoperatively) on surrogate endpoint biomarkers (i.e., prostate-specific antigen, high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy) in these patients. OUTLINE: This is a nonrandomized, controlled study. Patients are assigned to 1 of 2 groups based on the treating physician. * Control group: Patients undergo radical prostatectomy only. * Treatment group: Patients receive oral exisulind once daily for 4 weeks. Patients then undergo radical prostatectomy. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 130 patients (65 per group) will be accrued for this study within approximately 10-12 months.
Interventions
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN) | — |
Secondary
| Measure | Time frame |
|---|---|
| Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy) | — |
Countries
United States
Outcome results
None listed