OHSU

IRB #

IRB00009363

Title

PVAMC / OHSU J: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Principal Investigator

Julie Graff

Study Purpose

The purpose of this study is to see if ARN-509 is safe and effective in delaying the spread of your cancer to other parts of your body. The ARN-509 will be compared with a placebo to find out if it is effective or not.

Medical Condition(s)

Non-Metastatic Castrate Resistant Prostate Cancer

Eligibility Criteria

- Subjects must have prostate cancer which has not spread outside the prostate, with the exception of some pelvic lymph nodes.
- Rising PSA seen in 3 results in a row, at least one week apart, resulting in two 50% increases over the lowest point, with the last PSA greater then 2 ng/mL..
- Subjects must have adequate kidney and liver function.
- Subjects have not had any chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting; nor prior therapy with orteronel, ketoconazole, aminoglutethimide, enzalutamide, sipuleucel-T, or abiraterone.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until the subject and their physician decide to withdraw from the study or the subject develops metastatic disease.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Aragon Pharmaceuticals, Inc.

Recruitment End

09/30/2015

Compensation Provided

No


Go Back