Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00006101|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 12, 2018
Last Update Posted : May 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: eflornithine Drug: Placebo||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
U.S. FDA Resources
500mg/d for 12 months
Take 500mg of DFMO per day for 12 months
Other Name: Difluoromethylornithine (DFMO)
Placebo Comparator: Placebo
placebo for 12 months
Take placebo per day for 12 months
- Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months [ Time Frame: 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.
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): NCT00006101
|United States, California|
|Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Thomas Ahlering, MD||Professor|