CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

• Adenocarcinoma of the prostate (as the predominant histology)

• High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:

‣ Greater than or equal to (≥)4 bone metastases by bone scan and/or

⁃ ≥1 visceral metastases by computed tomography or magnetic resonance imaging

• Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.

• Adequate organ function

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1