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)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05288166

Run by

Eli Lilly and Company

People needed

925

Starts

2022-04-14

Expected to finish

2027-10-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Alliance — Westbury, New York, United States
• UZ Gent — Ghent, Oost-Vlaanderen, Belgium
• Arizona Oncology Associates, P.C. - HOPE — Prescott, Arizona, United States
• Arizona Oncology Associates, P.C. - HOPE — Prescott Valley, Arizona, United States
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
• Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States
• St. Bernards Medical Center — Jonesboro, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• Providence Medical Foundation — Fullerton, California, United States
• Moores Cancer Center — La Jolla, California, United States
• MemorialCare Health System - Long Beach Medical Center — Long Beach, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• UCLA Hematology/Oncology - Santa Monica — Los Angeles, California, United States
• Torrance Memorial Physician Network / Cancer Care — Torrance, California, United States
• PIH Health Hematology Medical Oncology — Whittier, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• UCHealth Memorial Hospital — Colorado Springs, Colorado, United States
• UCHealth Harmony — Fort Collins, Colorado, United States
• Colorado West Healthcare System - Grand Valley Oncology — Grand Junction, Colorado, United States
• USO-Rocky Mountain Cancer Center — Littleton, Colorado, United States
• Florida Cancer Specialists - South — Fort Myers, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Millennium Oncology Research Clinic — Hollywood, Florida, United States
• Associated Medical Professionals - Urology — Syracuse, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.