CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,231 enrolled
Drug / intervention
Dutasteride +1 moredrug
Likely dose
Dutasteride 0.5 mg orally once daily for up to 4 yearsAI-extracted
Key inclusion· 3
  • ✓Single negative prostate biopsy within 6 months prior to enrollment
  • ✓PSA 2.5-10 ng/mL if age 50-60, or PSA 3.0-10 ng/mL if over age 60
  • ✓Ability and willingness to participate in study for 4 years
Key exclusion· 8
  • ✕More than one previous negative prostate biopsy
  • ✕History of prostate cancer
  • ✕Previous prostate surgery
  • ✕Inability to urinate requiring catheter use in past 2 years

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

Search/NCT00056407
NCT00056407Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer

GlaxoSmithKline·interventional·Posted Mar 13, 2003·Updated Sep 23, 2016

In Brief

A Phase 3 clinical trial evaluating Dutasteride and Placebo for Neoplasms, Prostate. Completed, enrolled 8,231 participants across 932 sites in 42 countries.

Detailed Summary

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Prostate
Countries, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2003
Enrollment StartMar 1, 2003
Primary CompletionJan 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 23.3 years ago

Interventions

Dutasteridedrug

After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.

Placebodrug

After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.