IRB #

IRB00008791

Title

The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer

Principal Investigator

Joshi Alumkal

Study Purpose

The purpose of this study is to compare how the study drug ARN-509, when used alone or in combination with a commonly used medicine called a Luteinizing Hormone-Releasing Hormone (LHRH) agonist, affects your quality of life, your overall health, and your prostate cancer after 12 months of treatment.

Medical Condition(s)

Biochemically Relapsed Hormone Sensitive Prostate Cancer

Eligibility Criteria

-Rising PSA after prior definitive therapy for localized prostate cancer, including radical prostatectomy, external beam radiation therapy, brachytherapy, or combination of radical prostatectomy and radiotherapy.
-Minimum PSA of 1.0ng/mL (prostatectomy) or 2.0 ng/mL (without prostatectomy).
-No evidence of metastatic disease.
-Does not have a history of osteoporosis.
-Does not have a history of seizures or medical condition which lowers seizure threshold.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

12 months on active treatment, 12 months of follow-up

Minors Included

No

Contact

Seonaid Squires, 503 418-9104

Sponsor

Aragon Pharmaceuticals

Recruitment End

12/31/2014

Compensation Provided

No