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ACTIVE NOT RECRUITING
NCT05288166
PHASE3

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

View on ClinicalTrials.gov

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

2025-06-27

Healthy Volunteers

No

Interventions

DRUG

Abemaciclib

Administered orally.

DRUG

Abiraterone

Administered orally.

DRUG

Prednisone or Prednisolone

Administered orally.

DRUG

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

Centro Avançado de Tratamento Oncológico- CENANTRON

Belo Horizonte, Minas Gerais, Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Hospital de Cancer de Londrina

Londrina, Paraná, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Oncologia Saint Gallen

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Clínica de Oncologia Reichow

Blumenau, Santa Catarina, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Instituto de de Educação, pesquisa e Gestão em Saúde

Rio de Janeiro, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo

São Paulo, Brazil

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Afflilated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Second Affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Sun Yat-Sen University Cancer Centre

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Wuhan Union Hospital

Wuhan, Hubei, China

Tongji Hospital Tongji Medical,Science & Technology

Wuhan, Hubei, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Nanchong Central Hospital

Nanchong, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

Nemocnice Horovice

Hořovice, Beroun, Czechia

Masarykuv onkologicky ustav

Brno, Brno-město, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha 10, Czechia

Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia

Oblastni nemocnice Pribram

Příbram, Příbram, Czechia

Fakultni Nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Urocentrum Praha

Prague, Czechia

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Brittany Region, France

Polyclinique De Blois

La Chaussée-Saint-Victor, Centre-Val de Loire, France

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

CHU Besançon

Besançon, Doubs, France

Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-Roussillon, France

Hôpital privé du Confluent SAS

Nantes, Loire-Atlantique, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-Atlantique, France

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, France

Clinique Victor Hugo Le Mans

Le Mans, Sarthe, France

Hôpital Européen Georges Pompidou

Paris, France

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

NCT

Heidelberg, Baden-Wurttemberg, Germany

Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Würt, Germany

Klinikum Rechts Der Isar Der Technischen Universität München

Munich, Bavaria, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Urologicum Duisburg Fachärztesozietät - Walsum

Duisburg, North Rhine-Westphalia, Germany

Urologische Gemeinschaftspraxis Heinsberg

Heinsberg, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

Urologische Gemeinschaftspraxis Wesel

Wesel, North Rhine-Westphalia, Germany

InVO Institut für Versorgungsforschung in der Onkologie

Koblenz, Rhineland-Palatinate, Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Urologie Neandertal - Praxis Mettmann

Mettmann, Germany

Klinikum Nürnberg Nord

Nuremberg, Germany

University Hospital of Patras

Pátrai, Achaḯa, Greece

Agios Savvas Regional Cancer Hospital

Athens, Attikí, Greece

Alexandra Hospital

Athens, Attikí, Greece

Attikon General University Hospital

Chaïdári, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Irakleío, Greece

Bacs-Kiskun Megyei Korhaz

Kecskemét, Bács-Kiskun county, Hungary

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Országos Onkológiai Intézet

Budapest, Pest County, Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary

Meir Medical Center

Kfar Saba, Central District, Israel

Rabin Medical Center

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Rambam Health Care Campus

Haifa, Northern District, Israel

Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Istituto Oncologico Veneto IRCCS

Castelfranco Veneto, Veneto, Italy

Istituto Europeo di Oncologia IRCCS

Milan, Italy

Azienda Ospedaliera Santa Maria Terni

Terni, Italy

APSS- Presidio Ospedaliero S. Chiara

Trento, Italy

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kimitsu Chuo Hospital

Kisarazu, Chiba, Japan

Toho University Sakura Medical Center

Sakura, Chiba, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Kita, Kagawa-ken, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Nagano Municipal Hospital

Tomitake, Nagano, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Showa University Hospital

Shinagawa, Tokyo, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Osaka International Cancer Institute

Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Actualidad Basada en la Investigación del Cáncer

Guadalajara, Jalisco, Mexico

Health Pharma Professional Research S.A. de C.V:

Mexico City, Mexico City, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

Culiacán, Sinaloa, Mexico

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Mexico

ETZ Elisabeth

Tilburg, North Brabant, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Clinical Best Solutions

Lublin, Lublin Voivodeship, Poland

Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

Opole, Opole Voivodeship, Poland

Szpitale Pomorskie Sp. z o. o.

Gdynia, Pomeranian Voivodeship, Poland

Salve Medica

Lodz, Łódź Voivodeship, Poland

Provita Profamilia

Piotrkow Trybunalski, Łódź Voivodeship, Poland

C.M.D.T.A. Neomed

Brasov, Brașov County, Romania

Amethyst Radiotherapy Center

Florești, Cluj, Romania

Ovidius Clinical Hospital OCH

Ovidiu, Constanța County, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Radiology Therapeutic Center

Otopeni, Ilfov, Romania

Oncopremium Team

Baia Mare, Maramureş, Romania

SC Memorial Healthcare International SRL

Bucharest, Romania

Gral Medical Diagnostic Center

Bucharest, Romania

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Instituto Catalan de Oncologia - Hospital Duran i Reynals

Hospitalet, Barcelona [Barcelona], Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Fundación Instituto Valenciano de Oncología

Valencia, Valenciana, Comunitat, Spain

Hospital Infanta Cristina

Badajoz, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

National Taiwan University Hospital

Taipei City, Taipei, Taiwan

Taipei Veterans General Hospital

Taipei City, Taipei, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Medipol Mega Universite Hastanesi

Stanbul, Istanbul, Turkey (Türkiye)

Izmir Medical Park Hospital

Izmir, Karsiyaka, İzmir, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center

Adana, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi

Ankara, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Dicle Üniversitesi

Diyarbakır, Turkey (Türkiye)

Trakya University

Edirne, Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi

Malatya, Turkey (Türkiye)

Royal Blackburn Hospital

Blackburn, Blackburn With Darwen, United Kingdom

Colchester General Hospital

Colchester, Essex, United Kingdom

University College London Hospital

London, London, City of, United Kingdom