A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation
- Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with
localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by
- Compare the effect of these regimens on angiogenic factors within the prostate in these
- Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these
- 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
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Michael A. Carducci, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|