Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands
- 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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Anne R. Simoneau, MD
Chao Family Comprehensive Cancer Center
United States: Federal Government
|Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center||Orange, California 92868|