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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 925

Last updated 2025-06-27

Study results available
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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

DRUG

Abemaciclib

Administered orally.

DRUG

Abiraterone

Administered orally.

DRUG

Prednisone or Prednisolone

Administered orally.

DRUG

Placebo for Abemaciclib

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2024-02-15
Completion
2027-10-31
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288166 on ClinicalTrials.gov