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)
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)
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator — From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months) The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
Trial sites (266)
Facility
City
Region
Status
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.
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.
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