Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: eflornithine

• Registration Number: NCT00006101
• Lead Sponsor: Thomas E. Ahlering

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.

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 2000-08-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2018-02-07
• Results First Submitted QC: 2018-03-13
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Results First Posted: 2018-04-12
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo for 12 months
eflornithine	eflornithine	500mg/d for 12 months

Primary Outcome Measures

Name	Time	Method
Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months	Baseline and 12 months	Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center; 🇺🇸 Orange, California, United States