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Clinical Trials: S1216: 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

 


S1216: 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


Trial Focus

Prostate Cancer

Objective

         This is a clinical trial of leuprolide acetate or goserelin acetate that will be administered by subcutaneous injection which is standard of care and TAK-700 (orteronel) that will be administered by mouth and is investigational.

IRB Protocol #

13-2467

Trial Status

OPEN

Principle Investigator

PAUL MARONI

Sponsor

SWOG

Contact

MICHAEL WACKER at (720)848-3427 or MICHAEL.WACKER@UCDENVER.EDU

Location

University of Colorado Hospital University of Colorado Hospital

Eligibility and Other Participant Information


What To Expect : A screening period to determine eligibility. A treatment period(s) that can last up to 52 weeks. A follow up period will consist of clinic visits. // Eligibility criteria include but are not limited to 18 years or older with prostate cancer.Eligibility criteria include but are not limited to 18 years or older with prostate cancer.