A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
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.
Non-Metastatic Castrate Resistant Prostate Cancer
- 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.
18 - 100
Healthy Volunteers Needed
Duration of Participation
Until the subject and their physician decide to withdraw from the study or the subject develops metastatic disease.
Clinical Trials Information Line: Phone 503-494-1080 or firstname.lastname@example.org
Aragon Pharmaceuticals, Inc.