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Title:
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:
J1315
Phase:
Phase III
Physician:
Emmanuel Antonarakis
Purpose:
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
Eligibility:
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
Treatment:
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)
Population:
Adult
Last Update
12/22/2014 04:03 AM
 

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