IRB #

IRB00008613

Title

A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy

Principal Investigator

Tomasz Beer

Study Purpose

The purpose of this study is to give patients early access to MDV3100 while it is in the approval process in the FDA.

Medical Condition(s)

Prostate cancer where docetaxel chemotherapy is no longer working to fight your cancer.

Eligibility Criteria

-Failed docetaxel-based chemotherapy
-Metastatic castration-resistant prostate cancer
-Never received MDV3100 on PREVAIL, a previous clinical study of MDV-3100

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The study will continue until the approval of the study drug by the FDA, which is expected to occur in 12 months. You will also be taken off study if the drug no longer is working against your prostate cancer.

Minors Included

No

Contact

Erin Tucker
503.494.8729
lamayee@ohsu.edu

Sponsor

Astellas Pharma Global Development, Inc.

Recruitment End

05/31/2013

Compensation Provided

No