Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|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 Start Date:||September 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022399
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Michael A. Carducci, MD||Sidney Kimmel Comprehensive Cancer Center|