Trial Identifiers
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Scientific Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Commercial Sponsor
Janssen-Cilag Pty Ltd
Summary
Eligible patients will be randomised to receive androgen deprivation therapy plus oral Apalutamide or a placebo daily in each (28 day) cycle. Participants will receive six cycles of treatment, followed by radical prostatectomy, followed by an additional six cycles of treatment.