OHSU

IRB #

IRB00009892

Title

PVAMC / OHSU J: 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

Principal Investigator

Julie Graff

Study Purpose

The purpose of this study is to compare the overall survival of two groups of patients: those randomly assigned to get androgen deprivation therapy (ADT, in the form of leuprolide or goserelin acetate) plus TAK-700 (the study drug), and those who receive ADT plus bicalutamide (an anti-androgen). This study will compare how long it takes for participants in each group to progress (how long it takes for their cancer to spread), what kind of PSA response each group has, and side effects of both groups.

Medical Condition(s)

Prostate cancer

Eligibility Criteria

- Subjects must have confirmed adenocarcinoma of the prostate that has spread to other parts of their body, or “metastasized” (spread to bones, lymph nodes, etc; except cancer that has spread to the brain)
- Subjects must have adequate kidney and liver function
- Subjects must have not had hormonal therapy before, or if so, it must not have lasted more than 36 months and it must have finished greater than 6 months ago
- Subjects must not have had any chemotherapy for metastatic cancer
Age range 18+

Age Range

18 - 150

Healthy Volunteers Needed

No

Duration of Participation

Duration of participation- Up to 10 years after you stop treatment or for the rest of your life, whichever occurs first.

Minors Included

No

Contact

Clinical trials information line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Southwest Oncology Group (SWOG) and Millennium Pharmaceuticals, Inc.

Recruitment End

01/20/2016

Compensation Provided

No


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