Skip Navigation
Search Menu

Print This Page
Share this page: More

Search Results

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer (ARN-509-003)
Protocol Number:
Phase III
Emmanuel Antonarakis
Sibley Memorial Hospital
Johns Hopkins Kimmel Cancer Center in Baltimore
To demonstrate superiority in the metastasis-free survival of men with high risk NM-CRPC treated with ARN-509 versus placebo, To compare the overall survival of men with high risk NM-CRPC treated with ARN-509 versus placebo
Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT)/post orchiectomy with rising PSAs, PSA doubling time less than/equal to 10 months, must be 18 years of age or older, must be in good physical shape, must have good blood/kidney/liver functions, must not have any metastasis, must not have received any prior chemo therapy unless it was given in the adjuvant/neoadjuvant setting, must not have a history of seizure, must not be taking systemic corticosteroids,must not have any active cardiac conditions, must not have uncontrolled hypertension
Study treatment will consist of ARN-509/matching placebo 240 mg (eight 30 mg capsules) daily. Patient will be randomized to receive either the drug or placebo and the randomization will be blinded to both the patient and the study staff. The dose will be taken once daily with or without food. Patients are to come to the clinic once every cycle (28 days). Patients may remain on study until there is any radiological evidence of progression, not just PSA increases)
Last Update
05/29/2016 05:03 AM

Read Our Blogs
Cancer Matters: timely topics
Our Cancer: for caregivers


Cancer Dictionary

NCI Dictionary of Cancer Terms, a resource with more than 6,000 terms related to cancer and medicine.