OHSU

IRB #

IRB00010241

Title

Molecular Mechanisms Underlying Tumor Progression Despite Enzalutamide Treatment

Principal Investigator

Joshi Alumkal

Study Purpose

The purpose of this study is to better understand how cancer treatment of Enzalutamide (MDV3100) may affect prostate cancer cells. The research will involve genetic, molecular, cellular and immunologic experiments using blood and tumor specimens. It is hoped that the information gained from these studies will lead to a greater understanding of castrate-resistant prostate cancer, Enzalutamide resistance and potentially, improvements in cancer treatment.

Medical Condition(s)

Prostate cancer that has spread outside the prostate and no longer responds to hormonal treatment

Eligibility Criteria

-Patients with prostate cancer that has spread outside the prostate
- Disease is worsening despite being currently on hormonal therapy (androgen deprivation therapy)
-Willing to undergo a tumor biopsy before starting treatment and at disease progression
-Never been treated with chemotherapy (docetaxel), abiraterone acetate (Zytiga), MDV3100 (Enzalutamide or XTANDI), ARN-509, or TAK700

Age Range

18 - 100+

Healthy Volunteers Needed

No

Duration of Participation

You will have study visits just before you first start taking Enzalutamide, when you start taking it, at week 6 and week 12 after starting Enzalutamide treatment and then every subsequent 12 weeks until your cancer stops responding to Enzalutamide treatment (about 6 months to 3 years). We will continue to check on you by telephone for the rest of your life.

Minors Included

No

Contact

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

Sponsor

Oregon Health & Science University, and Astellas Scientific and Medical Affairs Inc

Recruitment End

12/30/2016

Compensation Provided

No


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