neoadjuvant exisulind in treating patients who are undergoing radical prostatectomy for stage ii or stage iii prostate cancer

Conditions: Prostate Cancer

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.

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.

Eligibility 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

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer