Conditions: Prostate Cancer
Keywords: stage I prostate cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of eflornithine (DMFO) 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.

Detailed description:
OBJECTIVES:

* 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.

Arms:
arm 1: 500mg/d for 12 months arm 2: placebo for 12 months

Interventions: intervention 1: eflornithine intervention 2: Placebo
Intervention descriptions: intervention 1: Take 500mg of DFMO per day for 12 months intervention 2: Take placebo per day for 12 months

Protocol document: