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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebos; Drug: celecoxib

• Registration Number: NCT00022399
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2001-08-10
• Study Start: 2002-04-25
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-01-31
• Study Completion: 2005-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo-control	Placebos	Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.
Celecoxib	celecoxib	Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States