Spots Global Cancer Trial Database for Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

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Trial Identification

Brief Title: Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

Official Title: A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation

Study ID: NCT00022399

Conditions

Prostate Cancer

Interventions

celecoxib

Placebos

Study Description

Brief Summary: 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.

Detailed Description: 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.