AzTrials
AzTrials

Prostatic NeoplasmsPhase 3CYCLONE 3NCT05288166

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)

A Phase 3 study testing Abemaciclib, Abiraterone and Prednisone or Prednisolone in people with Prostatic Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 266 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abemaciclib, Abiraterone and Prednisone or Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
925 participants
Where
266 sitesin 24 countries
Study dates
14 Apr 2022to Oct 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

266 sites in 24 countries.

266 sites in 24 countries

United States63 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Texas Oncology - Balcones

    Austin, Texas, 78731

  • MidLantic urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Sarah Cannon Research Institute

    Baton Rouge, Louisiana, 70809

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Maimonides Cancer Center

    Brooklyn, New York, 11220

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05405

  • Tennessee Oncology Chattanooga-SCRI

    Chattanooga, Tennessee, 37404

  • TriState Urologic Services PSC Inc.

    Cincinnati, Ohio, 45212

  • Care Access - Clifton

    Clifton, New Jersey, 07013

  • UCHealth Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Parkland Health and Hospital System

    Dallas, Texas, 75235

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Texas Oncology - Carrollton

    Flower Mound, Texas, 75028

  • UCHealth Harmony

    Fort Collins, Colorado, 80528

  • Dwight D Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Colorado West Healthcare System - Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Millennium Oncology Research Clinic

    Hollywood, Florida, 33024

  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas, 71913

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Moores Cancer Center

    La Jolla, California, 92093

  • USO-Rocky Mountain Cancer Center

    Littleton, Colorado, 80120

  • MemorialCare Health System - Long Beach Medical Center

    Long Beach, California, 90806

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • UCLA Hematology/Oncology - Santa Monica

    Los Angeles, California, 90404

  • The University of Louisville, James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Minnesota Oncology/Hematology PA

    Minneapolis, Minnesota, 55404

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Arizona Oncology Associates, P.C. - HOPE

    Prescott, Arizona, 86301

  • Arizona Oncology Associates, P.C. - HOPE

    Prescott Valley, Arizona, 86314

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Roanoke, Virginia, 24014

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Summit Cancer Care DBA Candler Medical Oncology Practice

    Savannah, Georgia, 31405

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • USO - Texas Oncology Gulf Coast

    Sugar Land, Texas, 77479

  • Associated Medical Professionals - Urology

    Syracuse, New York, 13210

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508

  • US Oncology Research Network

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialist

    Tigard, Oregon, 97223

  • Torrance Memorial Physician Network / Cancer Care

    Torrance, California, 90505

  • Chesapeake Urology

    Towson, Maryland, 21204

  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

  • Texas Oncology - Longview Cancer Center

    Tyler, Texas, 75702

  • Florida Cancer Specialist- East

    West Palm Beach, Florida, 33401

  • Clinical Research Alliance

    Westbury, New York, 11590

  • PIH Health Hematology Medical Oncology

    Whittier, California, 90602

  • Reliant Medical Group

    Worcester, Massachusetts, 01606

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

China31 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

  • Afflilated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Jilin Cancer Hospital

    Changchun, Jilin, 132000

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Sun Yat-Sen University Cancer Centre

    Guangzhou, Guangdong, 510060

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Second Affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanchong Central Hospital

    Nanchong, Sichuan, 637000

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300020

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical,Science & Technology

    Wuhan, Hubei, 430030

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

Other trials in China

Australia18 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Monash Health

    Clayton, Victoria, 3168

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Barwon Health

    Geelong, Victoria, 3220

  • Austin Health

    Heidelberg, Victoria, 3084

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Macquarie University

    Macquarie University, New South Wales, 2109

  • St Vincent's Hospital

    Melbourne, Victoria, 3065

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Epworth Freemasons

    Richmond, Victoria, 3121

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101

  • Tasman Oncology Research

    Southport, Queensland, 4215

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany16 sites

  • Urologicum Duisburg Fachärztesozietät - Walsum

    Duisburg, North Rhine-Westphalia, 47169

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • NCT

    Heidelberg, Baden-Wurttemberg, 69120

  • Urologische Gemeinschaftspraxis Heinsberg

    Heinsberg, North Rhine-Westphalia, 52525

  • InVO Institut für Versorgungsforschung in der Onkologie

    Koblenz, Rhineland-Palatinate, 56068

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Urologie Neandertal - Praxis Mettmann

    Mettmann, 40822

  • Klinikum Rechts Der Isar Der Technischen Universität München

    Munich, Bavaria, 81675

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Würt, 72076

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Urologische Gemeinschaftspraxis Wesel

    Wesel, North Rhine-Westphalia, 46483

Other trials in Germany

Japan15 sites

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Kimitsu Chuo Hospital

    Kisarazu, Chiba, 292-8535

  • Kagawa University Hospital

    Kita, Kagawa-ken, 761-0701

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-0841

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Showa University Hospital

    Shinagawa, Tokyo, 142-8555

  • Nagano Municipal Hospital

    Tomitake, Nagano, 381-8551

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Argentina13 sites

  • Investigaciones Clinicas Moleculares (ICM)

    Buenos Aires, Buenos Aires F.D., 1425

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, Buenos Air, C1419AHN

  • Centro Oncologico Korben

    Buenos Aires, 1426

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • Fundación Cenit Para La Investigación En Neurociencias

    CABA, Ciudad Autónoma de Buenos Aire, 1125

  • Centro Medico Privado CEMAIC

    Capital, Córdoba Province, X5008HHW

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP

  • Centro Urológico Profesor Bengió

    Córdoba, 5000

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZO

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, 5800

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

    San Juan, 5400

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Brazil13 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784400

  • Centro Avançado de Tratamento Oncológico- CENANTRON

    Belo Horizonte, Minas Gerais, 30130090

  • Clínica de Oncologia Reichow

    Blumenau, Santa Catarina, 89010-340

  • Centro Integrado de Oncologia de Curitiba

    Curitiba, Paraná, 80810050

  • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

    Fortaleza, Ceará, 60430230

  • Hospital de Cancer de Londrina

    Londrina, Paraná, 86015-520

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto de de Educação, pesquisa e Gestão em Saúde

    Rio de Janeiro, 22775-001

  • Nucleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-070

  • Instituto de Oncologia Saint Gallen

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01221-020

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

  • Núcleo de Pesquisa Clínica da Rede São Camilo

    São Paulo, 04014-002

Other trials in Brazil

France11 sites

  • CHU Besançon

    Besançon, Doubs, 25000

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

    Brest, Brittany Region, 29200

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • Polyclinique De Blois

    La Chaussée-Saint-Victor, Centre-Val de Loire, 41260

  • Clinique Victor Hugo Le Mans

    Le Mans, Sarthe, 72000

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69373

  • Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-Roussillon, 34070

  • Hôpital privé du Confluent SAS

    Nantes, Loire-Atlantique, 44277

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-Atlantique, 44805

Other trials in France

Turkey (Türkiye)9 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 01250

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara

  • Dicle Üniversitesi

    Diyarbakır, 21200

  • Trakya University

    Edirne, 22030

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

    Istanbul, 34722

  • Izmir Medical Park Hospital

    Izmir, Karsiyaka, İzmir, 009035575

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi

    Malatya, 44280

  • Medipol Mega Universite Hastanesi

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Czechia8 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno, South Moravian, 656 91

  • Nemocnice Horovice

    Hořovice, Beroun, 268 31

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha 10, 10034

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059

  • Urocentrum Praha

    Prague, 120 00

  • Oblastni nemocnice Pribram

    Příbram, Příbram, 261 01

Other trials in Czechia

Romania8 sites

  • Oncopremium Team

    Baia Mare, Maramureş, 430291

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283

  • SC Memorial Healthcare International SRL

    Bucharest, 013812

  • Gral Medical Diagnostic Center

    Bucharest, 031422

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542

  • Amethyst Radiotherapy Center

    Florești, Cluj, 407280

  • Radiology Therapeutic Center

    Otopeni, Ilfov, 075100

  • Ovidius Clinical Hospital OCH

    Ovidiu, Constanța County, 905900

Other trials in Romania

Israel7 sites

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906

  • Yitzhak Shamir Medical Center

    Tsrifin, Central District, 70300

Other trials in Israel

Italy7 sites

  • Istituto Oncologico Veneto IRCCS

    Castelfranco Veneto, Veneto, 31033

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

  • APSS- Presidio Ospedaliero S. Chiara

    Trento, 38122

Other trials in Italy

Spain7 sites

  • Hospital Infanta Cristina

    Badajoz, 06006

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Hospitalet, Barcelona [Barcelona], 08907

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valenciana, Comunitat, 46009

Other trials in Spain

Mexico6 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31203

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

    Culiacán, Sinaloa, 80230

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara, Jalisco, 44680

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

    Mexico City, Mexico City, 03100

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

Other trials in Mexico

Taiwan6 sites

  • China Medical University Hospital

    Taichung, 404332

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei City, Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei City, Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Greece5 sites

  • Agios Savvas Regional Cancer Hospital

    Athens, Attikí, 115 22

  • Alexandra Hospital

    Athens, Attikí, 115 28

  • Attikon General University Hospital

    Chaïdári, Attikí, 12462

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 711 10

  • University Hospital of Patras

    Pátrai, Achaḯa, 26504

Other trials in Greece

Poland5 sites

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, Pomeranian Voivodeship, 81-519

  • Salve Medica

    Lodz, Łódź Voivodeship, 91-211

  • Clinical Best Solutions

    Lublin, Lublin Voivodeship, 20-011

  • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

    Opole, Opole Voivodeship, 45-061

  • Provita Profamilia

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300

Other trials in Poland

Belgium4 sites

  • Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, Oost-Vlaanderen, 9300

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West-Vlaanderen, 8500

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Hungary4 sites

  • Országos Onkológiai Intézet

    Budapest, Pest County, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9024

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bács-Kiskun county, 6000

Other trials in Hungary

South Korea4 sites

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

Other trials in South Korea

United Kingdom3 sites

  • Royal Blackburn Hospital

    Blackburn, Blackburn With Darwen, BB2 3HH

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • University College London Hospital

    London, London, City of, NW1 2PG

Other trials in United Kingdom

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • ETZ Elisabeth

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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.

Being tested
Abemaciclib, Abiraterone, Prednisone or Prednisolone, Placebo for Abemaciclib
Keywords
Metastatic Hormone Sensitive Prostate Cancer, mHSPC, Stage IV Prostate Cancer, Recurrent Prostate Cancer, De Novo Metastatic Prostate Cancer, High-Risk, Visceral metastasis, Cyclin-Dependent Kinase 4 (CDK4), Cyclin-Dependent Kinase 6 (CDK6), CDK4, CDK6, CDK4/6
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally.

  • AbirateroneDrug

    Administered orally.

  • Prednisone or PrednisoloneDrug

    Administered orally.

  • Placebo for AbemaciclibDrug

    Administered orally.

Study groups in NCT05288166
Study groupRoleWhat they receive
AbemaciclibExperimentalParticipants 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.
Receives: Drug: Abemaciclib; Drug: Abiraterone; Drug: Prednisone or Prednisolone
PlaceboActive comparatorParticipants 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.
Receives: Drug: Abiraterone; Drug: Prednisone or Prednisolone; Drug: Placebo for Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)

Secondary outcomes (7)

  1. 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.

    Measured: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: From Date of Randomization to Date of Death Due to Any Cause (Up to 22 Months)

  4. Time to Pain Progression

    Measured: Randomization to pain progression (up to 22 months)

  5. 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.

    Measured: Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)

  6. 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.

    Measured: Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)

  7. Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib

    Maximum plasma concentration at steady state (Cmax,ss) of abemaciclib was evaluated.

    Measured: Predose on Cycle 1 Day 1, Predose and Predose on Cycle 2 Day 1 and Predose on Cycle 3 Day 1 (28 Day Cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start14 Apr 2022
  3. Primary completion15 Feb 2024
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
925 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05288166
Sponsor's protocol ID
18448
Other IDs
I3Y-MC-JPEG, 2022-500461-28-06
Acronym
CYCLONE 3
Status last verified
Jun 2026
First submitted
10 Mar 2022
Last updated
1 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib, Abiraterone and Prednisone or Prednisolone in people with Prostatic Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 266 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in United States, China, Australia, Germany, Japan and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) Assessed by Investigator (time frame: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05288166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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