Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00022399|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: celecoxib Drug: Placebos||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||April 25, 2002|
|Actual Primary Completion Date :||January 31, 2005|
|Actual Study Completion Date :||January 31, 2005|
Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.
400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
Other Name: celebrex
Placebo Comparator: Placebo-control
Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.
Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|