A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Trial Profile

A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Jun 2017

At a glance

  • Drugs Enzalutamide (Primary) ; Bicalutamide
  • Indications Prostate cancer
  • Focus Therapeutic Use
  • Acronyms TERRAIN
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 10 Mar 2017 Planned End Date changed from 1 Mar 2017 to 1 Jul 2017.
    • 21 Nov 2016 According to an Astellas Pharma media release, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XTANDI (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study.
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