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)
NCT05288166 · CYCLONE 3 Phase 3Active, not recruiting
- Lead sponsor
- Eli Lilly and Company (Industry)
- Enrollment
- 925 (actual)
- Start date
- 14 Apr 2022
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 1 Oct 2027
- Last update posted
- 1 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 2
Interventions
- Abemaciclib Drug
- Abiraterone Drug
- Prednisone or Prednisolone Drug
- Placebo for Abemaciclib Drug
Conditions and primary outcome
- 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
Primary outcome
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator (From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT05288166 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Baseline up to 22 months
| Group | Affected | At risk |
|---|---|---|
| Abemaciclib | 145 | 460 |
| Placebo | 68 | 460 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT05288166.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05288166 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.