CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
eflornithine +1 moredrug
Likely dose
Eflornithine (DFMO) 500 mg orally once daily for 12 monthsAI-extracted
Key inclusion· 3
  • ✓Men aged 35-70 with family history of prostate cancer: either two or more affected relatives (at least 1 first-degree) or at least two second-degree relatives or one first-degree relative diagnosed at age 55 or less
  • ✓Willing and able to attend required study visits and complete questionnaires
  • ✓ECOG performance status 0-1
Key exclusion· 9
  • ✕History of invasive cancer within 5 years (except non-melanoma skin cancer or papillary bladder cancer)
  • ✕Prior history of prostate cancer (except localized Gleason score ≤7 managed with watchful waiting)
  • ✕Severe metabolic disorders or other life-threatening acute or chronic disease
  • ✕Currently requiring regular use of anticoagulants

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006101
NCT00006101Phase 2Completed
CompareCT.gov

Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands

Thomas E. Ahlering·interventional·Posted Jan 27, 2003·Updated May 14, 2018

In Brief

A Phase 2 clinical trial evaluating eflornithine and Placebo for Prostate Cancer. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartOct 1, 1998
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 14.2 yearsPosted 23.4 years ago

Interventions

eflornithinedrug

Take 500mg of DFMO per day for 12 months

Placebodrug

Take placebo per day for 12 months