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Clinical Trials in the UK / NCT05288166
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 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2022-04-14
Last updated
2026-07-01

Condition(s) studied

Prostatic NeoplasmsNeoplasm MetastasisUrogenital NeoplasmsPhysiological Effects of DrugsAntineoplastic AgentsAntineoplastic Agents, HormonalAndrogensHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAbiraterone AcetateSteroid Synthesis InhibitorsCytochrome P-450Enzyme InhibitorsPrednisonePrednisoloneCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6

Investigational drug(s) / intervention(s)

AbemaciclibAbirateronePrednisone or PrednisolonePlacebo for Abemaciclib

Abemaciclib: Administered orally.

Abiraterone: Administered orally.

Prednisone or Prednisolone: Administered orally.

Placebo for Abemaciclib: Administered orally.

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Adenocarcinoma of the prostate (as the predominant histology) * High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as: * Greater than or equal to (≥)4 bone metastases by bone scan and/or * ≥1 visceral metastases by computed tomography or magnetic resonance imaging * Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen. * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 \& 6) inhibitor * Development of metastatic prostate cancer in the context of castrate levels of testosterone * Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen * Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure * History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted * Uncontrolled hypertension * Clinically active or chronic liver disease, moderate/severe hepatic impairment * Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization

Primary outcome measure(s)

Trial sites (266)

FacilityCityRegionStatus
Arizona Oncology Associates, P.C. - HOPE Prescott Arizona
Arizona Oncology Associates, P.C. - HOPE Prescott Valley Arizona
The University of Arizona Cancer Center - North Campus Tucson Arizona
Genesis Cancer and Blood Institute Hot Springs Arkansas
St. Bernards Medical Center Jonesboro Arkansas
Highlands Oncology Group Springdale Arkansas
Orange Coast Memorial Medical Center Fountain Valley California
Providence Medical Foundation Fullerton California
Moores Cancer Center La Jolla California
MemorialCare Health System - Long Beach Medical Center Long Beach California
Cancer and Blood Specialty Clinic Los Alamitos California
UCLA Hematology/Oncology - Santa Monica Los Angeles California
Torrance Memorial Physician Network / Cancer Care Torrance California
PIH Health Hematology Medical Oncology Whittier California
University of Colorado Anschutz Medical Campus Aurora Colorado
UCHealth Memorial Hospital Colorado Springs Colorado
UCHealth Harmony Fort Collins Colorado
Colorado West Healthcare System - Grand Valley Oncology Grand Junction Colorado
USO-Rocky Mountain Cancer Center Littleton Colorado
Florida Cancer Specialists - South Fort Myers Florida
Memorial Regional Hospital Hollywood Florida
Millennium Oncology Research Clinic Hollywood Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida
Florida Cancer Specialist- East West Palm Beach Florida
Dwight D Eisenhower Army Medical Center Fort Gordon Georgia
Northeast Georgia Medical Center Gainesville Georgia
Central Georgia Cancer Care Macon Georgia
Summit Cancer Care DBA Candler Medical Oncology Practice Savannah Georgia
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
The University of Louisville, James Graham Brown Cancer Center Louisville Kentucky
Sarah Cannon Research Institute Baton Rouge Louisiana
Chesapeake Urology Towson Maryland
Massachusetts General Hospital Boston Massachusetts
Reliant Medical Group Worcester Massachusetts
University of Massachusetts Chan Medical School Worcester Massachusetts
Minnesota Oncology/Hematology PA Minneapolis Minnesota
Care Access - Clifton Clifton New Jersey
Maimonides Cancer Center Brooklyn New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York
Laura and Isaac Perlmutter Cancer Center New York New York

+ 226 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile → 📄 Zytiga (abiraterone) drug profile →

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05288166 on ClinicalTrials.gov ↗ ← All trials in the UK