Phase 3  | 

CYCLONE 3; NCT05288166

Prostate Cancer

CDK4 & 6 Inhibitor

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*  

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Key Inclusion Criteria
  • Adenocarcinoma of the prostate (as the predominant histology)
  • High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as: ≥4 bone metastases by bone scan and/or ≥1 visceral metastases by CT or MRI
  • 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
Key Exclusion Criteria
  • Prior treatment with abemaciclib or any other CDK4 & 6 inhibitor
  • Development of metastatic prostate cancer in the context of castrate levels of testosterone
  • Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
  • Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association class II to IV heart failure
  • History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
  • Uncontrolled hypertension
  • Clinically active or chronic liver disease, moderate/severe hepatic impairment
  • Known untreated central nervous system (CNS) metastasis. Patients with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization
This clinical trial is being conducted globally.
Abiraterone, prednisone (or prednisolone), and abemaciclib or placebo equivalent are administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.