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)
← catalyst calendarSponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
925actual
Sites
266
Countries
Argentina, Australia, Belgium +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-04-14 | actual | When the study began enrolling |
| Primary completion | 2024-02-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-21 | actual | When this record first appeared on the registry |
| Results posted | 2025-06-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
- Drug: Abemaciclib — also filed as LY2835219
- Drug: Abiraterone
- Drug: Prednisone or Prednisolone
- Drug: Placebo for Abemaciclib
Primary outcome
what the primary-completion date above is the date OFRadiographic Progression-Free Survival (rPFS) Assessed by Investigator
measured From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-06-06 · 20.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-01-17 · 4.7 MB · SAP_001.pdf
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