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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

925

Participants

Timeline

Start Date

April 14, 2022

Primary Completion Date

February 15, 2024

Study Completion Date

October 31, 2027

Conditions
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
Interventions
DRUG

Abemaciclib

Administered orally.

DRUG

Abiraterone

Administered orally.

DRUG

Prednisone or Prednisolone

Administered orally.

DRUG

Placebo for Abemaciclib

Administered orally.

Trial Locations (266)

333

Chang Gung Medical Foundation-Linkou Branch, Taoyuan District

407

Taichung Veterans General Hospital, Taichung

704

National Cheng Kung University Hospital, Tainan City

1062

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1122

Országos Onkológiai Intézet, Budapest

1125

Fundación Cenit Para La Investigación En Neurociencias, CABA

1425

Investigaciones Clinicas Moleculares (ICM), Buenos Aires

1426

Centro Oncologico Korben, Buenos Aires

2010

St Vincent's Hospital, Darlinghurst

2050

Chris O'Brien Lifehouse, Camperdown

2109

Macquarie University, Macquarie University

2170

Liverpool Hospital, Liverpool

2450

Coffs Harbour Health Campus, Coffs Harbour

3065

St Vincent's Hospital, Melbourne

3084

Austin Health, Heidelberg

3121

Epworth Freemasons, Richmond

3128

Box Hill Hospital, Box Hill

3168

Monash Health, Clayton

3220

Barwon Health, Geelong

4000

Centro Medico San Roque, San Miguel de Tucumán

4101

Icon Cancer Centre South Brisbane, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4215

Tasman Oncology Research, Southport

5000

Centro Urológico Profesor Bengió, Córdoba

CHU UCL Namur/Site Sainte Elisabeth, Namur

5037

Ashford Cancer Centre Research, Kurralta Park

5112

Lyell McEwin Hospital, Elizabeth Vale

5400

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan, San Juan

5800

Instituto Médico Río Cuarto, Río Cuarto

6000

Bacs-Kiskun Megyei Korhaz, Kecskemét

6150

Fiona Stanley Hospital, Murdoch

7000

Icon Cancer Centre Hobart, Hobart

8500

AZ Groeninge Campus Kennedylaan, Kortrijk

9000

UZ Gent, Ghent

9024

Petz Aladar Egyetemi Oktato Korhaz, Győr

9300

Onze Lieve Vrouw Ziekenhuis Aalst, Aalst

10002

National Taiwan University Hospital, Taipei City

10016

Laura and Isaac Perlmutter Cancer Center, New York

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

11217

Taipei Veterans General Hospital, Taipei City

11220

Maimonides Cancer Center, Brooklyn

11501

Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola

11590

Clinical Research Alliance, Westbury

12462

Attikon General University Hospital, Chaïdári

13210

Associated Medical Professionals - Urology, Syracuse

13273

Institut Paoli-Calmettes, Marseille

14059

Fakultni Thomayerova nemocnice, Prague

15212

AHN Allegheny General Hospital, Pittsburgh

19004

MidLantic urology, Bala-Cynwyd

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia IRCCS, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

21079

Centre Georges François Leclerc, Dijon

21200

Dicle Üniversitesi, Diyarbakır

21204

Chesapeake Urology, Towson

22030

Trakya University, Edirne

24014

Oncology and Hematology Associates of Southwest Virginia Inc, Roanoke

25000

CHU Besançon, Besançon

26504

University Hospital of Patras, Pátrai

28009

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29200

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan, Brest

30501

Northeast Georgia Medical Center, Gainesville

30905

Dwight D Eisenhower Army Medical Center, Fort Gordon

31033

Istituto Oncologico Veneto IRCCS, Castelfranco Veneto

31201

Central Georgia Cancer Care, Macon

31203

Scientia Investigacion Clinica S.C., Chihuahua City

31405

Summit Cancer Care DBA Candler Medical Oncology Practice, Savannah

33021

Memorial Regional Hospital, Hollywood

33024

Millennium Oncology Research Clinic, Hollywood

33136

University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami

33401

Florida Cancer Specialist- East, West Palm Beach

33901

Florida Cancer Specialists - South, Fort Myers

34070

Centre de Cancérologie du Grand Montpellier, Montpellier

34214

Medipol Mega Universite Hastanesi, Stanbul

34722

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

37203

Sarah Cannon Research Institute, Nashville

37404

Tennessee Oncology Chattanooga-SCRI, Chattanooga

37920

University of Tennessee Medical Center, Knoxville

38122

APSS- Presidio Ospedaliero S. Chiara, Trento

40202

The University of Louisville, James Graham Brown Cancer Center, Louisville

40822

Urologie Neandertal - Praxis Mettmann, Mettmann

41013

Hospital Universitario Virgen Del Rocio, Seville

41260

Polyclinique De Blois, La Chaussée-Saint-Victor

44277

Hôpital privé du Confluent SAS, Nantes

44280

İnönü Üniversitesi Turgut Özal Tıp Merkezi, Malatya

44680

Actualidad Basada en la Investigación del Cáncer, Guadalajara

44805

Institut de Cancérologie de l'Ouest, Saint-Herblain

45212

TriState Urologic Services PSC Inc., Cincinnati

46009

Fundación Instituto Valenciano de Oncología, Valencia

46483

Urologische Gemeinschaftspraxis Wesel, Wesel

46804

Fort Wayne Medical Oncology and Hematology, Fort Wayne

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

47169

Urologicum Duisburg Fachärztesozietät - Walsum, Duisburg

48149

Universitätsklinikum Münster - Albert Schweitzer Campus, Münster

52525

Urologische Gemeinschaftspraxis Heinsberg, Heinsberg

55131

Universitätsmedizin Johannes Gutenberg Universität Mainz, Mainz

55404

Minnesota Oncology/Hematology PA, Minneapolis

56068

InVO Institut für Versorgungsforschung in der Onkologie, Koblenz

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

66460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

69120

NCT, Heidelberg

69373

Centre Leon Berard, Lyon

70300

Yitzhak Shamir Medical Center, Ẕerifin

70809

Sarah Cannon Research Institute, Baton Rouge

71913

Genesis Cancer and Blood Institute, Hot Springs

72000

Clinique Victor Hugo Le Mans, Le Mans

72076

Universitaetsklinikum Tuebingen, Tübingen

72401

St. Bernards Medical Center, Jonesboro

72622

Studienpraxis Urologie, Nürtingen

72762

Highlands Oncology Group, Springdale

75015

Hôpital Européen Georges Pompidou, Paris

75028

Texas Oncology - Carrollton, Flower Mound

75235

Parkland Health and Hospital System, Dallas

75390

UT Southwestern Medical Center, Dallas

75702

Texas Oncology - Longview Cancer Center, Tyler

76104

The Center for Cancer and Blood Disorders, Fort Worth

76508

Baylor Scott & White Medical Center - Temple, Temple

77030

Houston Methodist Hospital, Houston

77380

US Oncology Research Network, The Woodlands

77479

USO - Texas Oncology Gulf Coast, Sugar Land

78229

Urology San Antonio Research, San Antonio

78731

Texas Oncology - Balcones, Austin

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80045

University of Colorado Anschutz Medical Campus, Aurora

80120

USO-Rocky Mountain Cancer Center, Littleton

80230

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

80528

UCHealth Harmony, Fort Collins

80909

UCHealth Memorial Hospital, Colorado Springs

81505

Colorado West Healthcare System - Grand Valley Oncology, Grand Junction

81675

Klinikum Rechts Der Isar Der Technischen Universität München, Munich

84112

Huntsman Cancer Institute, Salt Lake City

85719

The University of Arizona Cancer Center - North Campus, Tucson

86301

Arizona Oncology Associates, P.C. - HOPE, Prescott

86314

Arizona Oncology Associates, P.C. - HOPE, Prescott Valley

89081

Universitaetsklinikum Ulm, Ulm

90404

UCLA Hematology/Oncology - Santa Monica, Los Angeles

90419

Klinikum Nürnberg Nord, Nuremberg

90505

Torrance Memorial Physician Network / Cancer Care, Torrance

90602

PIH Health Hematology Medical Oncology, Whittier

90720

Cancer and Blood Specialty Clinic, Los Alamitos

90806

MemorialCare Health System - Long Beach Medical Center, Long Beach

92093

Moores Cancer Center, La Jolla

92708

Orange Coast Memorial Medical Center, Fountain Valley

92835

Providence Medical Foundation, Fullerton

97223

Northwest Cancer Specialist, Tigard

100005

Beijing Hospital, Beijing

100034

Peking University First Hospital, Beijing

100142

Beijing Cancer hospital, Beijing

132000

Jilin Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Fudan University Shanghai Cancer Center, Shanghai

200040

Huadong Hospital Affiliated to Fudan University, Shanghai

200072

Shanghai Tenth People's Hospital, Shanghai

200080

Shanghai General Hospital, Shanghai

200542

"Centrul de Oncologie Sfântul Nectarie", Craiova

225001

Northern Jiangsu People's Hospital, Yangzhou

230601

Second Affiliated hospital of Anhui Medical University, Hefei

233004

Afflilated Hospital of Bengbu Medical College, Bengbu

241001

Wannan Medical College Yijishan Hospital, Wuhu

264099

Yantai Yuhuangding Hospital, Yantai

300020

Tianjin Medical University Cancer Institute and Hospital, Tianjin

300211

The Second Hospital of Tianjin Medical University, Tianjin

310003

The First Affiliated Hospital, Zhejiang University, Hangzhou

310014

Zhejiang Provincial People's Hospital, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

315010

Ningbo First Hospital, Ningbo

330006

The First Affiliated Hospital of Nanchang University, Nanchang

404332

China Medical University Hospital, Taichung

407280

Amethyst Radiotherapy Center, Florești

410005

Hunan Provincial People's Hospital, Changsha

410008

Xiangya Hospital Central South University, Changsha

410013

Hunan Cancer Hospital, Changsha

430022

Wuhan Union Hospital, Wuhan

430030

Tongji Hospital Tongji Medical,Science & Technology, Wuhan

430291

Oncopremium Team, Baia Mare

500283

C.M.D.T.A. Neomed, Brasov

510060

Sun Yat-Sen University Cancer Centre, Guangzhou

510515

Southern Medical University Nanfang Hospital, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

637000

Nanchong Central Hospital, Nanchong

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

905900

Ovidius Clinical Hospital OCH, Ovidiu

3109601

Rambam Health Care Campus, Haifa

4428164

Meir Medical Center, Kfar Saba

4941492

Rabin Medical Center, Petah Tikva

5265601

Sheba Medical Center, Ramat Gan

6423906

Sourasky Medical Center, Tel Aviv

9112001

Hadassah Medical Center, Jerusalem

14784400

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos

30130090

Centro Avançado de Tratamento Oncológico- CENANTRON, Belo Horizonte

60430230

Centro de Pesquisa Clínica do Instituto do Câncer do Ceará, Fortaleza

80810050

Centro Integrado de Oncologia de Curitiba, Curitiba

02114

Massachusetts General Hospital, Boston

01606

Reliant Medical Group, Worcester

01655

University of Massachusetts Chan Medical School, Worcester

07013

Care Access - Clifton, Clifton

05405

The University of Vermont Medical Center Inc., Burlington

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata

C1419AHN

Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires

C1027AAP

Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire

X5008HHW

Centro Medico Privado CEMAIC, Capital

R8500ACE

Clinica Viedma, Viedma

C1426ABP

Fundación Respirar, Buenos Aires

40170-070

Nucleo de Oncologia da Bahia, Salvador

86015-520

Hospital de Cancer de Londrina, Londrina

90610-000

Hospital São Lucas da PUCRS, Porto Alegre

96830-180

Instituto de Oncologia Saint Gallen, Santa Cruz do Sul

89010-340

Clínica de Oncologia Reichow, Blumenau

22775-001

Instituto de de Educação, pesquisa e Gestão em Saúde, Rio de Janeiro

01221-020

Instituto do Cancer Arnaldo Vieira de Carvalho, São Paulo

01246-000

Icesp - Instituto Do Câncer Do Estado de São Paulo, São Paulo

04014-002

Núcleo de Pesquisa Clínica da Rede São Camilo, São Paulo

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

268 31

Nemocnice Horovice, Hořovice

656 53

Masarykuv onkologicky ustav, Brno

261 01

Oblastni nemocnice Pribram, Příbram

656 91

Fakultni Nemocnice u sv. Anny v Brne, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

120 00

Urocentrum Praha, Prague

115 22

Agios Savvas Regional Cancer Hospital, Athens

115 28

Alexandra Hospital, Athens

711 10

University General Hospital of Heraklion, Heraklion

00168

Fondazione Policlinico Universitario Agostino Gemelli, Rome

05100

Azienda Ospedaliera Santa Maria Terni, Terni

466-8650

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

292-8535

Kimitsu Chuo Hospital, Kisarazu

285-0841

Toho University Sakura Medical Center, Sakura

060-8648

Hokkaido University Hospital, Sapporo

650-0047

Kobe City Medical Center General Hospital, Kobe

920-8641

Kanazawa University Hospital, Kanazawa

761-0701

Kagawa University Hospital, Kita

232-0024

Yokohama City University Medical Center, Yokohama

381-8551

Nagano Municipal Hospital, Tomitake

431-3192

Hamamatsu University Hospital, Hamamatsu

142-8555

Showa University Hospital, Shinagawa

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

541-8567

Osaka International Cancer Institute, Osaka

545-8586

Osaka Metropolitan University Hospital, Osaka

03100

Health Pharma Professional Research S.A. de C.V:, Mexico City

5022 GC

ETZ Elisabeth, Tilburg

9713 GZ

University Medical Center Groningen, Groningen

20-011

Clinical Best Solutions, Lublin

45-061

Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego, Opole

81-519

Szpitale Pomorskie Sp. z o. o., Gdynia

91-211

Salve Medica, Lodz

97-300

Provita Profamilia, Piotrkow Trybunalski

075100

Radiology Therapeutic Center, Otopeni

013812

SC Memorial Healthcare International SRL, Bucharest

031422

Gral Medical Diagnostic Center, Bucharest

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08907

Instituto Catalan de Oncologia - Hospital Duran i Reynals, Hospitalet

06006

Hospital Infanta Cristina, Badajoz

009035575

Izmir Medical Park Hospital, Izmir, Karsiyaka

01250

Baskent University Dr. Turgut Noyan Research and Training Center, Adana

06800

Ankara Bilkent Şehir Hastanesi, Ankara

Unknown

Ankara Universitesi Tip Fakultesi Hastanesi, Ankara

BB2 3HH

Royal Blackburn Hospital, Blackburn

CO4 5JL

Colchester General Hospital, Colchester

NW1 2PG

University College London Hospital, London

All Listed Sponsors
lead

Eli Lilly and Company

INDUSTRY