Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of eflornithine may be an effective way to prevent the development of prostate cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands|
|Study Start Date:||October 1998|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Eflornithine (DFMO)
500mg/d for 12 months
Placebo Comparator: Placebo
placebo for 12 months
- Compare the levels of polyamines (putrescine, spermidine, and spermine) and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine (DFMO) vs placebo.
- Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (35 to 60 vs 61 to 70) and presence of localized cancer (yes vs no).
All patients receive oral placebo daily for 4 weeks. Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms.
- Arm I: Patients receive oral placebo daily.
- Arm II: Patients receive high-dose oral eflornithine (DFMO) daily. Treatment continues for 1 year in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006101
|United States, California|
|Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center|
|Orange, California, United States, 92868|
|Study Chair:||Anne R. Simoneau, MD||Chao Family Comprehensive Cancer Center|