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) (CYCLONE 3)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urogenital Neoplasms; Prostatic Neoplasms; Neoplasm Metastasis; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Androgens; Hormones, Hormone Substitutes, and Hormone Antagonists; Abiraterone Acetate; Steroid Synthesis Inhibitors; Cytochrome P-450; Prednisone; Prednisolone; Cyclin-Dependent Kinase 4; Cyclin-Dependent Kinase 6
• Intervention / Treatment: Drug: Abemaciclib; Drug: Abiraterone; Drug: Prednisone or Prednisolone; Drug: Placebo for Abemaciclib

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: clinicaltrials.gov@lilly.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Buenos Aires, Argentina, 1426
    • Centro Oncologico Korben
  • Córdoba, Argentina, 5000
    • Centro Urologico Profesor Bengio
  • San Juan, Argentina, 5400
    • CER San Juan
  • Buenos Air
    • Buenos Aires, Buenos Air, Argentina, C1419AHN
      • Asociación de Beneficencia Hospital Sirio Libanés
    • Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina, C1027AAP
      • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clínicas Mar del Plata
  • Ciudad Autónoma De Buenos Aire
    • Caba, Ciudad Autónoma De Buenos Aire, Argentina, 1125
      • Fundación CENIT para la Investigación en Neurociencias
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1425
      • Investigaciones Clinicas Moleculares (ICM)
  • Córdoba
    • Capital, Córdoba, Argentina, X5008HHW
      • Centro Medico Privado CEMAIC
    • Río Cuarto, Córdoba, Argentina, 5800
      • Instituto Médico Río Cuarto
  • Río Negro
    • Viedma, Río Negro, Argentina, R8500ACE
      • Clinica Viedma
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
      • Centro Medico San Roque
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Harbour Health Campus
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Centre South Brisbane
    • Southport, Queensland, Australia, 4215
      • Tasman Oncology Research
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Aust
    • Kurralta Park, South Aust, Australia, 5037
      • Ashford Cancer Centre Research
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Icon Cancer Centre Hobart
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital
    • Richmond, Victoria, Australia, 3121
      • Epworth Freemasons
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Belgium
  • Namur, Belgium, 5000
    • CHU UCL Namur/Site Sainte Elisabeth
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Onze Lieve Vrouw Ziekenhuis Aalst
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Az Groeninge Campus Kennedylaan
• Brazil
  • Rio de Janeiro, Brazil, 22775-001
    • Grupo COI - Clínicas Oncológicas Integradas
  • São Paulo, Brazil, 01221-020
    • Instituto do Cancer Arnaldo Vieira de Carvalho
  • São Paulo, Brazil, 01246-000
    • Icesp - Instituto Do Câncer Do Estado de São Paulo
  • São Paulo, Brazil, 04014-002
    • Nucleo de Pesquisa Clinica da Rede Sao Camilo
  • Bahia
    • Salvador, Bahia, Brazil, 40170-070
      • Núcleo de Oncologia da Bahia
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430230
      • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130090
      • Centro Avançado de Tratamento Oncológico- CENANTRON
  • Paraná
    • Curitiba, Paraná, Brazil, 80810050
      • Centro Integrado de Oncologia de Curitiba
    • Londrina, Paraná, Brazil, 86015-520
      • Hospital de Cancer de Londrina
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
    • Santa Cruz do Sul, Rio Grande Do Sul, Brazil, 96830-180
      • Instituto de Oncologia Saint Gallen
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Clínica de Oncologia Reichow
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Fundação Pio XII - Hospital de Câncer de Barretos
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Afflilated Hospital of Bengbu Medical College
    • Hefei, Anhui, China, 230601
      • Second Affiliated Hospital of Anhui Medical University
    • Wuhu, Anhui, China, 241001
      • Wannan Medical College Yijishan Hospital
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100005
      • Beijing Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University Nanfang Hospital
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Centre
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical,Science & Technology
  • Hunan
    • ChangSha, Hunan, China, 410005
      • Hunan Provincial People's Hospital
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 132000
      • Jilin Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Yantai, Shandong, China, 264099
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200072
      • Shanghai Tenth People's Hospital
    • Shanghai, Shanghai, China, 200040
      • Huadong Hospital Affiliated To Fudan University
  • Sichuan
    • ChengDu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Nanchong, Sichuan, China, 637000
      • Nanchong Central Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300211
      • The Second Hospital of Tianjin Medical University
    • Tianjin, Tianjin, China, 300020
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Prague, Czechia, 120 00
    • Urocentrum Praha
  • Beroun
    • Horovice, Beroun, Czechia, 268 31
      • Nemocnice Horovice
  • Brno-město
    • Brno, Brno-město, Czechia, 656 53
      • Masarykuv onkologicky ustav
  • Jihomoravský Kraj
    • Brno, Jihomoravský Kraj, Czechia, 656 91
      • Fakultni Nemocnice u sv. Anny v Brne
  • Praha 10
    • PRague, Praha 10, Czechia, 10034
      • Fakultni nemocnice Kralovske Vinohrady
  • Praha 4
    • Prague, Praha 4, Czechia, 14059
      • Fakultni Thomayerova nemocnice
  • Příbram
    • Pribram, Příbram, Czechia, 261 01
      • Oblastni nemocnice Pribram
• France
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Bretagne
    • Brest, Bretagne, France, 29200
      • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
  • Centre
    • La Chaussée-Saint-Victor, Centre, France, 41260
      • Polyclinique De Blois
  • Côte-d'Or
    • Dijon, Côte-d'Or, France, 21079
      • Centre Georges François Leclerc
  • Doubs
    • Besançon, Doubs, France, 25000
      • CHU Besançon
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34070
      • Centre de Cancerologie du Grand Montpellier
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44277
      • Hopital Prive du Confluent SAS
    • Saint Herblain, Loire-Atlantique, France, 44805
      • Institut de Cancérologie de l'Ouest
  • Provence-Alpes-Côte-d'Azur
    • Marseille, Provence-Alpes-Côte-d'Azur, France, 13273
      • Institut Paoli-Calmettes
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69373
      • Centre Leon Berard
  • Sarthe
    • Le Mans, Sarthe, France, 72000
      • Clinique Victor Hugo Le Mans
• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Mettmann, Germany, 40822
    • Urologie Neandertal - Praxis Mettmann
  • Nürnberg, Germany, 90419
    • Klinikum Nürnberg Nord
  • Baden-Würt
    • Tübingen, Baden-Würt, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Universitaetsklinikum Freiburg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • NCT
    • Nürtingen, Baden-Württemberg, Germany, 72622
      • Studienpraxis Urologie
    • Ulm, Baden-Württemberg, Germany, 89081
      • Universitaetsklinikum Ulm
  • Bayern
    • Munich, Bayern, Germany, 81675
      • Klinikum rechts der Isar der Technischen Universitat Munchen
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt
  • Nordrhein-
    • Duisburg, Nordrhein-, Germany, 47169
      • Urologicum Duisburg Fachärztesozietät - Walsum
  • Nordrhein-Westfalen
    • Heinsberg, Nordrhein-Westfalen, Germany, 52525
      • Urologische Gemeinschaftspraxis Heinsberg
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitätsklinikum Münster - Albert Schweitzer Campus
    • Wesel, Nordrhein-Westfalen, Germany, 46483
      • Urologische Gemeinschaftspraxis Wesel
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • InVO Institut für Versorgungsforschung in der Onkologie
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin Johannes Gutenberg Universität Mainz
• Greece
  • Achaḯa
    • Patras, Achaḯa, Greece, 26504
      • University Hospital of Patras
  • Attikí
    • Athens, Attikí, Greece, 115 22
      • Agios Savvas Regional Cancer Hospital
    • Athens, Attikí, Greece, 115 28
      • Alexandra Hospital
    • Chaidari, Attikí, Greece, 12462
      • Attikon General University Hospital
  • Irakleío
    • Heraklion, Irakleío, Greece, 711 10
      • University General Hospital of Heraklion
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Bács-Kiskun
    • Kecskemét, Bács-Kiskun, Hungary, 6000
      • Bacs-Kiskun Varmegyei Oktatokorhaz
  • Győr-Moson-Sopron
    • Gyor, Győr-Moson-Sopron, Hungary, 9024
      • Petz Aladar Egyetemi Oktato Korhaz
  • Pest
    • Budapest, Pest, Hungary, 1122
      • Országos Onkológiai Intézet
• Israel
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center
    • Petah Tikva, HaMerkaz, Israel, 4941492
      • Rabin Medical Center
    • Ramat Gan, HaMerkaz, Israel, 5265601
      • Sheba Medical Center
    • Zerifin, HaMerkaz, Israel, 70300
      • Yitzhak Shamir Medical Center
  • HaTsafon
    • Haifa, HaTsafon, Israel, 3109601
      • Rambam Health Care Campus
  • Tell Abīb
    • Tel Aviv, Tell Abīb, Israel, 6423906
      • Sourasky Medical Center
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 9112001
      • Hadassah Medical Center
• Italy
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS
  • Terni, Italy, 05100
    • Azienda Ospedaliera Santa Maria Terni
  • Trento, Italy, 38122
    • APSS- Presidio Ospedaliero S. Chiara
  • Emilia-Rom
    • Meldola, Emilia-Rom, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli
  • Lombardia
    • Milan, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Veneto
    • Castelfranco Veneto, Veneto, Italy, 31033
      • Istituto Oncologico Veneto IRCCS
• Japan
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Aichi
    • Nagoya, Aichi, Japan, 466-8650
      • Japanese Red Cross Nagoya Daini Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
    • Kisarazu, Chiba, Japan, 292-8535
      • Kimitsu Chuo Hospital
    • Sakura, Chiba, Japan, 285-0841
      • Toho University Sakura Medical Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Kagawa
    • Kita, Kagawa, Japan, 761-0701
      • Kagawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
  • Nagano
    • Tomitake, Nagano, Japan, 381-8551
      • Nagano Municipal Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Shinagawa, Tokyo, Japan, 142-8555
      • Showa University Hospital
• Korea, Republic of
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
      • Seoul National University Hospital
• Mexico
  • Chihuahua, Mexico, 31203
    • Scientia Investigacion Clinica S.C.
  • Oaxaca, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca
  • Distrito Federal
    • Ciudad de México, Distrito Federal, Mexico, 03100
      • Health Pharma Professional Research S.A. de C.V:
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44680
      • Actualidad Basada en la Investigación del Cáncer
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80230
      • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Noord-Brabant
    • Tilburg, Noord-Brabant, Netherlands, 5022 GC
      • ETZ Elisabeth
• Poland
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-078
      • Clinical Best Solutions
  • Opolskie
    • Opole, Opolskie, Poland, 45-061
      • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-519
      • Szpitale Pomorskie Sp. z o. o.
  • Łódzkie
    • Lodz, Łódzkie, Poland, 91-211
      • Salve Medica
    • Piotrkow Trybunalski, Łódzkie, Poland, 97-300
      • Provita Profamilia
• Romania
  • București, Romania, 031422
    • Gral Medical Diagnostic Center
  • București, Romania, 021397
    • Centrul medical Focus
  • Brașov
    • Brasov, Brașov, Romania, 500283
      • C.M.D.T.A. Neomed
  • Cluj
    • Florești, Cluj, Romania, 407280
      • Amethyst Radiotherapy Center
  • Constanța
    • Ovidiu, Constanța, Romania, 905900
      • Ovidius Clinical Hospital OCH
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Centrul de Oncologie "Sfântul Nectarie"
  • Ilfov
    • Otopeni, Ilfov, Romania, 075100
      • Radiology Therapeutic Center
  • Maramureș
    • Baia Mare, Maramureș, Romania, 430291
      • Oncopremium Team
• Spain
  • Badajoz, Spain, 06006
    • Hospital Infanta Cristina
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
  • Barcelona [Barcelona]
    • Hospitalet, Barcelona [Barcelona], Spain, 08907
      • Instituto Catalan de Oncologia - Hospital Duran i Reynals
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28034
      • Hospital Universitario Ramon y Cajal
    • Madrid, Madrid, Comunidad De, Spain, 28041
      • Hospital Universitario 12 de Octubre
    • Madrid, Madrid, Comunidad De, Spain, 28009
      • Hospital General Universitario Gregorio Maranon
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46009
      • Fundación Instituto Valenciano de Oncología
• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404332
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Taipei
    • Taipei City, Taipei, Taiwan, 11217
      • Taipei Veterans General Hospital
    • Taipei City, Taipei, Taiwan, 10002
      • National Taiwan University Hospital
• Turkey
  • Adana, Turkey, 01250
    • Baskent University Dr. Turgut Noyan Research and Training Center
  • Ankara, Turkey, 06800
    • Ankara City Hospital
  • Ankara, Turkey
    • Ankara Universitesi Tip Fakultesi Hastanesi
  • Diyarbakir, Turkey, 21200
    • Dicle Üniversitesi
  • Edirne, Turkey, 22030
    • Trakya University
  • Istanbul, Turkey, 34722
    • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  • Malatya, Turkey, 44280
    • Inönü Üniversitesi Turgut Özal Tıp Merkezi
  • İstanbul
    • Stanbul, İstanbul, Turkey, 34214
      • Medipol Mega Universite Hastanesi
  • İzmir
    • Izmir, Karsiyaka, İzmir, Turkey, 009035575
      • Izmir Medical Park Hospital
• United Kingdom
  • Blackburn With Darwen
    • Blackburn, Blackburn With Darwen, United Kingdom, BB2 3HH
      • Royal Blackburn Hospital
  • Essex
    • Colchester, Essex, United Kingdom, CO4 5JL
      • Colchester General Hospital
  • London, City Of
    • London, London, City Of, United Kingdom, NW1 2PG
      • University College London Hospital
• United States
  • Arizona
    • Prescott Valley, Arizona, United States, 86314
      • Arizona Oncology Associates, P.C. - HOPE
    • Tucson, Arizona, United States, 85719
      • The University of Arizona Cancer Center - North Campus
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer and Blood Institute
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards Medical Center
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Fountain Valley, California, United States, 92708
      • Orange Coast Memorial Medical Center
    • Fullerton, California, United States, 92835
      • Providence Medical Foundation
    • La Jolla, California, United States, 92093
      • Moores Cancer Center
    • Long Beach, California, United States, 90806
      • MemorialCare Health System - Long Beach Medical Center
    • Los Alamitos, California, United States, 90720
      • Cancer and Blood Specialty Clinic
    • Los Angeles, California, United States, 90404
      • UCLA Hematology/Oncology - Santa Monica
    • Torrance, California, United States, 90505
      • Torrance Memorial Physician Network / Cancer Care
    • Whittier, California, United States, 90602
      • PIH Health Hematology Medical Oncology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
    • Colorado Springs, Colorado, United States, 80909
      • UCHealth Memorial Hospital
    • Fort Collins, Colorado, United States, 80528
      • UCHealth Harmony
    • Grand Junction, Colorado, United States, 81505
      • Colorado West Healthcare System - Grand Valley Oncology
    • Littleton, Colorado, United States, 80120
      • USO-Rocky Mountain Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists - South
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Hollywood, Florida, United States, 33024
      • Millennium Oncology - Hollywood
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics, Sylvester Cancer Center
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialist- East
  • Georgia
    • Fort Gordon, Georgia, United States, 30905
      • Dwight D Eisenhower Army Medical Center
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Macon, Georgia, United States, 31201
      • Central Georgia Cancer Care
    • Savannah, Georgia, United States, 31405
      • Candler OncologyMedical Practice
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • The University of Louisville, James Graham Brown Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Sarah Cannon Research Institute
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
    • Worcester, Massachusetts, United States, 01606
      • Reliant Medical Group
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology/Hematology PA
  • New Jersey
    • Clifton, New Jersey, United States, 07013
      • Care Access - Clifton
  • New York
    • Brooklyn, New York, United States, 11220
      • Maimonides Cancer Center
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals - Urology
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • TriState Urologic Services PSC Inc.
  • Oregon
    • Tigard, Oregon, United States, 97223
      • Northwest Cancer Specialist
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Pittsburgh, Pennsylvania, United States, 15212
      • AHN Allegheny General Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology Chattanooga-SCRI
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Balcones
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hospital System
    • Flower Mound, Texas, United States, 75028
      • Texas Oncology - Carrollton
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
    • Sugar Land, Texas, United States, 77479
      • USO - Texas Oncology Gulf Coast
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center - Temple
    • The Woodlands, Texas, United States, 77380
      • US Oncology Research Network
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Longview Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Vermont
    • Burlington, Vermont, United States, 05405
      • The University of Vermont Medical Center Inc.
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone; Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.	Drug: Abemaciclib; Administered orally.; Other Names: LY2835219; Drug: Abiraterone; Administered orally.; Drug: Prednisone or Prednisolone; Administered orally.
Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone; Placebo + abiraterone + prednisone/prednisolone administered orally.	Drug: Abiraterone; Administered orally.; Drug: Prednisone or Prednisolone; Administered orally.; Drug: Placebo for Abemaciclib; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator	rPFS Assessed by Investigator	Randomization to radiographic progression or death from any cause (approximately 48 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rPFS Assessed by Blinded Independent Central Review (BICR)	rPFS Assessed by BICR	Randomization to radiographic progression or death from any cause (approximately 48 months)
Castration-resistant Prostate Cancer (CRPC)-free Survival	CRPC-free Survival	Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dL); or death from any cause (approximately 48 months)
Overall Survival (OS)	OS	Baseline to date of death due to any cause (approximately 60 months)
Time to Pain Progression	Measured by a combination of 2 scales, the Brief Pain Inventory Short Form (BPI-SF) Worst Pain Numeric Rating Scale (NRS) and the Analgesic Quantification Algorithm (AQA) scale. The BPI-SF Worst Pain NRS is a self-reported 11-item questionnaire on worst pain intensity on the past 24 hours. Score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). The AQA scores analgesic use from 0 (minimum) to 7 (maximum).	Randomization to pain progression (approximately 48 months)
Time to Deterioration in Health-Related Quality of Life (HRQoL)	Measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P; Physical well-being and Prostate Cancer Subscale). The FACT-P is a 39-item self-reported questionnaire that assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life.	Randomization to the date of HRQoL deterioration (approximately 48 Months)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib	PK: Mean steady state exposure of abemaciclib	Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• 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) (CYCLONE 3)

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mHSPC; CDK4/6; CDK4; CDK6; High-Risk; Metastatic Hormone Sensitive Prostate Cancer; Stage IV Prostate Cancer; Recurrent Prostate Cancer; De Novo Metastatic Prostate Cancer; Visceral metastasis; Cyclin-Dependent Kinase 4 (CDK4); Cyclin-Dependent Kinase 6 (CDK6)
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms; Hypersensitivity; Prostatic Neoplasms; Neoplasm Metastasis; Urogenital Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone; Prednisone
• Other Study ID Numbers: 18448; I3Y-MC-JPEG (Other Identifier: Eli Lilly and Company); 2022-500461-28-06 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No