UI Hospitals and Clinics

Clinical Trial Details

Short Title
Official Title
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Description

Participants in this research study have prostate cancer that has spread and they are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days.

The purpose of this research study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone.  “Investigational” means that the drug has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of prostate cancer.  The combination of TAK-700 and standard hormone therapy is considered experimental (investigational).

Approximately 20 people will take part in this study conducted by investigators at the University of Iowa.  Approximately 1,636 people will take part in this study nationwide.

Start Date
May 10, 2013
End Date
May 15, 2018
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Daniel Vaena, MD
Contact Info

Clarine Halvorsen, 319-356-3944

Department
Keywords
cancer ; IRB#201304802 ; phase 3 ; phase III ; prostate ; TAK-700 ; vaena ;

We welcome your feedback! Please help us improve your experience on our website by completing a brief survey.