A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Candidate for radical prostatectomy as per the investigator

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

- Contraceptive (birth control) use by men (or female partners of men enrolled in the
study who are of childbearing potential or are pregnant) should be consistent with
local regulations regarding the acceptable methods of contraception for those
participating in clinical studies

- Able to receive androgen deprivation therapy (ADT) for up to 1 year, per the
investigator's assessment

Exclusion Criteria:

- Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation
(clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M
stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus
N0) will be assessed by central radiological review. Participants are considered
eligible only if the central radiological review confirms clinical stage M0

- Prior treatment with anti-androgen

- Prior treatment for prostate cancer

- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of
the prostat

- History of any pelvic radiation