A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

Official Title

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

Summary:

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

Trial Description

Primary Outcome:

  • Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
Secondary Outcome:
  • rPFS Assessed by Blinded Independent Central Review (BICR)
  • Castration-resistant Prostate Cancer (CRPC)-free Survival
  • Overall Survival (OS)
  • Time to Pain Progression
  • Time to Deterioration in Health-Related Quality of Life (HRQoL)
  • Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society