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

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Investigator: Eric J. Small, MD
Sponsor: Aragon Pharmaceuticals, Inc.

Location(s): United States

Description

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to evaluate the efficacy and safety of ARN-509 versus placebo in adult men with high-risk non-metastatic castration-resistant prostate cancer. Approximately 1200 participants will be randomly assigned in a 2:1 ratio to receive either ARN-509 (treatment arm A) or placebo (treatment arm B). Serial pharmacokinetic blood samples will be collected. Participants will be followed for safety and efficacy and will remain on study treatment until documented radiographic disease progression, development of unacceptable toxicity, or withdrawal of consent. Participants discontinuing study treatment will enter the survival follow-up period where they will be followed for the development of symptomatic progression and initiation of subsequent anti-cancer therapies, until death, loss of follow-up, or withdrawal of consent, whichever comes first. The total study duration will be approximately up to Month 59.