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 (Actual): 925
• Phase: Phase 3

Expanded Access

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Contacts and Locations

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
    • Centro Polivalente de Asistencia e Investigacion Clinica - 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 Clinicas 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 Medico Rio Cuarto
  • Río Negro
    • Viedma, Río Negro, Argentina, R8500ACE
      • Clínica Viedma
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
      • Centro Médico 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 Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
  • 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
    • Instituto de de Educação, pesquisa e Gestão em Saúde
  • 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
    • Núcleo de Pesquisa Clínica da Rede São 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 Sao 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
      • Clinica 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
    • Hôpital Europeen Georges Pompidou
  • Bretagne
    • Brest, Bretagne, France, 29200
      • Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
  • Centre
    • La Chaussée-Saint-Victor, Centre, France, 41260
      • Polyclinique de Blois
  • Côte-d'Or
    • Dijon, Côte-d'Or, France, 21079
      • Centre Georges Francois 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 Universität München
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt
  • Nordrhein-Westfalen
    • Duisburg, Nordrhein-Westfalen, Germany, 47169
      • Urologicum Duisburg Fachärztesozietät - Walsum
    • 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 Fur 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 Honvédség Egészségügyi Központ
  • Bács-Kiskun
    • Kecskemét, Bács-Kiskun, Hungary, 6000
      • Bacs-kiskun Megyei Korhaz
  • Győr-Moson-Sopron
    • Gyor, Győr-Moson-Sopron, Hungary, 9024
      • Petz Aladar Egyetemi Oktato Korhaz
  • Pest
    • Budapest, Pest, Hungary, 1122
      • Orszagos Onkologiai Intezet
• 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-Romagna
    • Meldola, Emilia-Romagna, 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 Metropolitan University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Aichi
    • Nagoya, Aichi, Japan, 466-8650
      • Japanese Red Cross Aichi Medical Center 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, 20-011
      • 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, 013812
    • SC Memorial Healthcare International SRL
  • 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 Marañón
  • 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 Bilkent Sehir Hastanesi
  • 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
    • İnönü 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, Arizona, United States, 86301
      • Arizona Oncology Associates, P.C. - HOPE
    • 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 Research Clinic
    • 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
      • Summit Cancer Care DBA Candler Medical Oncology 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 Chan 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; Participants received 200 milligram (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Abemaciclib; Administered orally.; Other Names: LY2835219; Drug: Abiraterone; Administered orally.; Drug: Prednisone or Prednisolone; Administered orally.
Active Comparator: Placebo; Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	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	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.	From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Progression-Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR)	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.	From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)
Castration-resistant Prostate Cancer (CRPC)-Free Survival	CRPC-free survival is defined as the time from the date of randomization to the earliest date of castration resistance, as demonstrated by any of the following (whichever occurs earliest): Confirmed prostate-specific antigen (PSA) progression with serum testosterone ≤50 nanogram/deciliter (ng/dL) (≤1.73 nanomoles per liter(nmol/L)). Investigator-assessed radiographic progression with serum testosterone ≤50 ng/dL (≤1.73 nmol/L). Death from any cause.	Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 ng/dL; or death from any cause (up to 22 months)
Overall Survival (OS)	The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.	From Date of Randomization to Date of Death Due to Any Cause (Up to 22 Months)
Time to Pain Progression		Randomization to pain progression (up to 22 months)
Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Physical Well-Being Subscale	Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Physical Well-Being subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Physical well-being subscale score ranges from 0 to 28 with high score indicating better quality of life.	Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)
Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Prostate Cancer Subscale	Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Prostate Cancer Subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Prostate cancer subscale score ranges from 0 to 48 with high score indicating better quality of life.	Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)
Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib	Maximum plasma concentration at steady state (Cmax,ss) of abemaciclib was evaluated.	Predose on Cycle 1 Day 1, Predose and Predose on Cycle 2 Day 1 and Predose on 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 (Actual): February 15, 2024
• 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): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

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: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Immune System Diseases; Neoplastic Processes; Neoplasms; Prostatic Neoplasms; Hypersensitivity; Neoplasm Metastasis; Urogenital Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone; Prednisolone
• 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