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
  • High-risk metastatic disease defined as ≥4 bone metastases and/or ≥1 visceral metastases 
  • Androgen deprivation therapy (with a luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or bilateral orchiectomy) must have been started prior to randomization
  • 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 (≤50 ng/dL)
  • Received any prior systemic therapy for metastatic prostate cancer (including investigational agents); the following exceptions are permitted:
    • Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
    • Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization
  • 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 provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use
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.