RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer. PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.
OBJECTIVES: * Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy. * Compare the effect of these regimens on angiogenic factors within the prostate in these patients. * Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients. * Compare the toxicity profiles of these regimens in these patients. * Compare the compliance of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral neoadjuvant celecoxib twice daily. * Arm II: Patients receive oral neoadjuvant placebo twice daily. Treatment in both arms continues for at least 4 weeks followed by prostatectomy. Patients are followed within 1 month and then at 3 months. PROJECTED ACCRUAL: A total of 60-70 patients (at least 30 per arm) will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
73
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
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