NCT05288166

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)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 925 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Neoplasms
• Neoplasm Metastasis
• Urogenital Neoplasms
• Physiological Effects of Drugs
• Antineoplastic Agents
• Antineoplastic Agents, Hormonal
• Androgens
• Hormones
• Hormones, Hormone Substitutes, and Hormone Antagonists
• Abiraterone Acetate
• Steroid Synthesis Inhibitors
• Cytochrome P-450
• Enzyme Inhibitors
• Prednisone
• Prednisolone
• Cyclin-Dependent Kinase 4
• Cyclin-Dependent Kinase 6

Interventions

Type	Name	Description
DRUG	Abemaciclib	Administered orally.
DRUG	Abiraterone	Administered orally.
DRUG	Prednisone or Prednisolone	Administered orally.
DRUG	Placebo for Abemaciclib	Administered orally.

Timeline

• Start date: 2022-04-14
• Primary completion: 2024-02-15
• Completion: 2027-10-01
• First posted: 2022-03-21
• Last updated: 2025-06-27
• Results posted: 2025-06-27

Locations

266 sites across 24 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study