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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)
Sponsor: Eli Lilly and Company
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.
Official title: CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
925
Start Date
2022-04-14
Completion Date
2027-10
Last Updated
2026-07-01
Healthy Volunteers
No
Conditions
Interventions
Abemaciclib
Administered orally.
Abiraterone
Administered orally.
Prednisone or Prednisolone
Administered orally.
Placebo for Abemaciclib
Administered orally.
Locations (266)
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
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Florida Cancer Specialist- East
West Palm Beach, Florida, United States
Dwight D Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Summit Cancer Care DBA Candler Medical Oncology Practice
Savannah, Georgia, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States
Sarah Cannon Research Institute
Baton Rouge, Louisiana, United States
Chesapeake Urology
Towson, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Reliant Medical Group
Worcester, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, United States
Care Access - Clifton
Clifton, New Jersey, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Associated Medical Professionals - Urology
Syracuse, New York, United States
Clinical Research Alliance
Westbury, New York, United States
TriState Urologic Services PSC Inc.
Cincinnati, Ohio, United States
Northwest Cancer Specialist
Tigard, Oregon, United States
MidLantic urology
Bala-Cynwyd, Pennsylvania, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Oncology Chattanooga-SCRI
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology - Balcones
Austin, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology - Carrollton
Flower Mound, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
USO - Texas Oncology Gulf Coast
Sugar Land, Texas, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States
US Oncology Research Network
The Woodlands, Texas, United States
Texas Oncology - Longview Cancer Center
Tyler, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke, Virginia, United States
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Investigaciones Clinicas Moleculares (ICM)
Buenos Aires, Buenos Aires F.D., Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, Buenos Air, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Fundación Cenit Para La Investigación En Neurociencias
CABA, Ciudad Autónoma de Buenos Aire, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Clinica Viedma
Viedma, Río Negro Province, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Oncologico Korben
Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, Argentina
Centro Urológico Profesor Bengió
Córdoba, Argentina
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Macquarie University
Macquarie University, New South Wales, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Tasman Oncology Research
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Epworth Freemasons
Richmond, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, West-Vlaanderen, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, Belgium
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, Ceará, Brazil
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil