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

• High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combinationof Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of GleasonScore 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores andProstate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targetedcore; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement

• Candidate for radical prostatectomy with pelvic lymph node dissection as per theinvestigator

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

• Contraceptive use by male participants (and female partners of male participantsenrolled in the study who are of childbearing potential or are pregnant) should beconsistent with local regulations regarding the use of contraceptive methods forparticipants participating in clinical studies

• Able to receive androgen deprivation therapy (ADT) for at least 13 months

Exclusion Criteria:

• Distant metastasis based on conventional imaging (clinical stage M1). Nodal diseasebelow the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis ofdistant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodaldisease (clinical N stage; N1 versus N0) will be assessed by central radiologicalreview. Participants are considered eligible only if the central radiological reviewconfirms clinical stage M0

• (a) Prior treatment with androgen receptor antagonists; (b) Treatment withgonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF)signature

• History of prior systemic or local therapy for prostate cancer, including pelvicradiation for prostate cancer

• Use of any investigational agent less than or equals to (<=)4 weeks prior torandomization or any therapeutic procedure for prostate cancer at any time

• Major surgery <=4 weeks prior to randomization

• Any of the following within 12 months prior to first dose of study drug: severe orunstable angina, myocardial infarction, symptomatic congestive heart failure,arterial or venous thromboembolic events (example, pulmonary embolism,cerebrovascular accident including transient ischemic attacks), or clinicallysignificant ventricular arrhythmias or New York Heart Association Class II to IVheart disease; uncomplicated deep vein thrombosis is not considered exclusionary