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Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 27, 2003
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

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.

Condition Intervention Phase
Prostate Cancer Drug: eflornithine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Resource links provided by NLM:

Further study details as provided by Chao Family Comprehensive Cancer Center, University of California, Irvine:

Enrollment: 140
Study Start Date: October 1998
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eflornithine (DFMO)
500mg/d for 12 months
Drug: eflornithine
Placebo Comparator: Placebo
placebo for 12 months
Drug: Placebo

Detailed Description:


  • 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Unaffected brother or first-degree cousin of a young (under age 70) prostate cancer proband with a family history (two or more first-degree relatives) of prostate cancer
  • No prior non-localized prostate cancer or previously diagnosed premalignant prostate disease



  • 35 to 70

Performance status:

  • SWOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 5 years


  • Hematocrit at least 35%
  • WBC at least 4,000/mm^3 with normal differential
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL
  • SGOT or SGPT less than 2 times normal


  • Creatinine less than 1.5 mg/dL
  • Less than 1+ protein, 0-3 casts, and 0-5 WBCs and RBCs in urine


  • No medically mandated special diet that would preclude compliance with study participation
  • No documented or symptomatic gastric or duodenal ulcer disease within the past year


  • No severe metabolic disorders or other life-threatening acute or chronic disease
  • No other invasive cancer within the past 5 years except nonmelanoma skin cancer
  • No predisposition to difficulties with wound healing or repair


Biologic therapy:

  • Not specified


  • No concurrent chemotherapy

Endocrine therapy:

  • At least 3 months since prior finasteride


  • No prior radiotherapy to pelvic area
  • No concurrent x-rays


  • Not specified


  • At least 3 months since prior chemoprevention agents
  • No aspirin or aspirin-containing products within 10 days prior to each study biopsy
  • No concurrent anticoagulants
  Contacts and Locations
Information from the National Library of Medicine

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
Sponsors and Collaborators
University of California, Irvine
National Cancer Institute (NCI)
Study Chair: Anne R. Simoneau, MD Chao Family Comprehensive Cancer Center
  More Information

Responsible Party: Chao Family Comprehensive Cancer Center, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00006101     History of Changes
Other Study ID Numbers: CDR0000068110
NCI-2009-00890 ( Other Identifier: NCI Clinical Trials Reporting Program )
First Submitted: August 3, 2000
First Posted: January 27, 2003
Last Update Posted: March 24, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chao Family Comprehensive Cancer Center, University of California, Irvine:
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action