Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Abemaciclib
  • DRUG Abiraterone
  • DRUG Prednisone or Prednisolone
  • DRUG Placebo for Abemaciclib

Study Locations (20)

California

  • Orange Coast Memorial Medical Center — Fountain Valley
  • Providence Medical Foundation — Fullerton
  • Moores Cancer Center — La Jolla
  • MemorialCare Health System - Long Beach Medical Center — Long Beach
  • Cancer and Blood Specialty Clinic — Los Alamitos
  • UCLA Hematology/Oncology - Santa Monica — Los Angeles
  • Torrance Memorial Physician Network / Cancer Care — Torrance
  • PIH Health Hematology Medical Oncology — Whittier

Colorado

  • University of Colorado Anschutz Medical Campus — Aurora
  • UCHealth Memorial Hospital — Colorado Springs
  • UCHealth Harmony — Fort Collins
  • Colorado West Healthcare System - Grand Valley Oncology — Grand Junction
  • USO-Rocky Mountain Cancer Center — Littleton

Arizona

  • Arizona Oncology Associates, P.C. - HOPE — Prescott
  • Arizona Oncology Associates, P.C. - HOPE — Prescott Valley
  • The University of Arizona Cancer Center - North Campus — Tucson

Arkansas

  • Genesis Cancer and Blood Institute — Hot Springs
  • St. Bernards Medical Center — Jonesboro
  • Highlands Oncology Group — Springdale

Florida

  • Florida Cancer Specialists - South — Fort Myers

Trial Details

FieldValue
Enrollment Target 925 participants
Start Date 2022-04-14
Est. Completion 2027-10
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05288166

The ClinicalTrials.gov registry entry for NCT05288166 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 925 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Abemaciclib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05288166 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05288166 about?

NCT05288166 is a clinical study titled "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)". 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.

What is the current status of trial NCT05288166?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 925 participants. The study started on 2022-04-14. Estimated completion is 2027-10.

What conditions does trial NCT05288166 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs, Hormones. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05288166?

The interventions under investigation include: Abemaciclib (DRUG), Abiraterone (DRUG), Prednisone or Prednisolone (DRUG), Placebo for Abemaciclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05288166?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05288166 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial