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)

Prostatic Neoplasms Clinical Trial

— CYCLONE 3  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05288166
• Other study ID #: 18448
• Secondary ID: I3Y-MC-JPEG2022-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 14, 2022
• Est. completion date: October 2027

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: October 2027
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abiraterone Acetate
• Androgens
• Antineoplastic Agents
• Enzyme Inhibitors
• Hormones
• Hormones, Hormone Substitutes, and Hormone Antagonists
• Hypersensitivity
• Neoplasm Metastasis
• Neoplasms
• Physiological Effects of Drugs
• Prostatic Neoplasms
• Urogenital Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally.
• Abiraterone
Administered orally.
• Prednisone or Prednisolone
Administered orally.
• Placebo for Abemaciclib
Administered orally.

Locations

Country	Name	City	State
Argentina	Asociación de Beneficencia Hospital Sirio Libanés	Buenos Aires	Buenos Air
Argentina	Centro Oncologico Korben	Buenos Aires
Argentina	Fundación Respirar	Buenos Aires
Argentina	Investigaciones Clinicas Moleculares (ICM)	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Fundación Cenit Para La Investigación En Neurociencias	Caba	Ciudad Autónoma De Buenos Aire
Argentina	Centro Medico Privado CEMAIC	Capital	Córdoba
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Air
Argentina	Centro Urológico Profesor Bengió	Córdoba
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Córdoba
Argentina	CER San Juan	San Juan
Argentina	Centro Medico San Roque	San Miguel de Tucumán	Tucumán
Argentina	Clinica Viedma	Viedma	Río Negro
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Monash Health	Clayton	Victoria
Australia	Coffs Harbour Health Campus	Coffs Harbour	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Barwon Health	Geelong	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Icon Cancer Centre Hobart	Hobart	Tasmania
Australia	Ashford Cancer Centre Research	Kurralta Park	South Aust
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Macquarie University	Macquarie University	New South Wales
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Epworth Freemasons	Richmond	Victoria
Australia	Icon Cancer Centre South Brisbane	South Brisbane	Queensland
Australia	Tasman Oncology Research	Southport	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst	Oost-Vlaanderen
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge Campus Kennedylaan	Kortrijk	West-Vlaanderen
Belgium	CHU UCL Namur/Site Sainte Elisabeth	Namur
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	São Paulo
Brazil	Centro Avançado de Tratamento Oncológico- CENANTRON	Belo Horizonte	Minas Gerais
Brazil	Clínica de Oncologia Reichow	Blumenau	Santa Catarina
Brazil	Centro Integrado de Oncologia de Curitiba	Curitiba	Paraná
Brazil	Centro de Pesquisa Clínica do Instituto do Câncer do Ceará	Fortaleza	Ceará
Brazil	Hospital de Cancer de Londrina	Londrina	Paraná
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul
Brazil	Grupo COI - Clínicas Oncológicas Integradas	Rio de Janeiro
Brazil	Nucleo de Oncologia da Bahia	Salvador	Bahia
Brazil	Instituto de Oncologia Saint Gallen	Santa Cruz do Sul	Rio Grande Do Sul
Brazil	Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo
Brazil	Instituto do Cancer Arnaldo Vieira de Carvalho	São Paulo
Brazil	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
China	Beijing Cancer hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Afflilated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Provincial People's Hospital	ChangSha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	ChengDu	Sichuan
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Centre	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Second Affiliated hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanchong Central Hospital	Nanchong	Sichuan
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Huadong Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
Czechia	Fakultni Nemocnice u sv. Anny v Brne	Brno	Jihomoravský Kraj
Czechia	Masarykuv onkologicky ustav	Brno	Brno-mesto
Czechia	Nemocnice Horovice	Horovice	Beroun
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Kralovske Vinohrady	PRague	Praha 10
Czechia	Fakultni Thomayerova nemocnice	Prague	Praha 4
Czechia	Urocentrum Praha	Prague
Czechia	Oblastni nemocnice Pribram	Pribram	Príbram
France	CHU Besançon	Besançon	Doubs
France	Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan	Brest	Bretagne
France	Centre Georges François Leclerc	Dijon	Côte-d'Or
France	Polyclinique De Blois	La Chaussée-Saint-Victor	Centre
France	Clinique Victor Hugo Le Mans	Le Mans	Sarthe
France	Centre Leon Berard	Lyon	Rhône-Alpes
France	Institut Paoli-Calmettes	Marseille	Provence-Alpes-Côte-d'Azur
France	Centre de Cancérologie du Grand Montpellier	Montpellier	Languedoc-Roussillon
France	Hôpital privé du Confluent SAS	Nantes	Loire-Atlantique
France	Hôpital Européen Georges Pompidou	Paris
France	Institut de Cancérologie de l'Ouest	Saint Herblain	Loire-Atlantique
Germany	Urologicum Duisburg Fachärztesozietät - Walsum	Duisburg	Nordrhein-
Germany	Universitätsklinikum Frankfurt	Frankfurt	Hessen
Germany	Universitaetsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	NCT	Heidelberg	Baden-Württemberg
Germany	Urologische Gemeinschaftspraxis Heinsberg	Heinsberg	Nordrhein-Westfalen
Germany	InVO Institut für Versorgungsforschung in der Onkologie	Koblenz	Rheinland-Pfalz
Germany	Universitätsmedizin Johannes Gutenberg Universität Mainz	Mainz	Rheinland-Pfalz
Germany	Urologie Neandertal - Praxis Mettmann	Mettmann
Germany	Klinikum Rechts Der Isar Der Technischen Universität München	Munich	Bayern
Germany	Universitätsklinikum Münster - Albert Schweitzer Campus	Münster	Nordrhein-Westfalen
Germany	Klinikum Nürnberg Nord	Nürnberg
Germany	Studienpraxis Urologie	Nürtingen	Baden-Württemberg
Germany	Universitaetsklinikum Tuebingen	Tübingen	Baden-Würt
Germany	Universitaetsklinikum Ulm	Ulm	Baden-Württemberg
Germany	Urologische Gemeinschaftspraxis Wesel	Wesel	Nordrhein-Westfalen
Greece	Agios Savvas Regional Cancer Hospital	Athens	Attikí
Greece	Alexandra Hospital	Athens	Attikí
Greece	Attikon General University Hospital	Chaidari	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	University Hospital of Patras	Patras	Acha?a
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Országos Onkológiai Intézet	Budapest	Pest
Hungary	Petz Aladar Egyetemi Oktato Korhaz	Gyor	Gyor-Moson-Sopron
Hungary	Bacs-Kiskun Varmegyei Oktatokorhaz	Kecskemét	Bács-Kiskun
Israel	Rambam Health Care Campus	Haifa	HaTsafon
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Rabin Medical Center	Petah Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Sourasky Medical Center	Tel Aviv	Tell Abib
Israel	Yitzhak Shamir Medical Center	Zerifin	HaMerkaz
Italy	Istituto Oncologico Veneto IRCCS	Castelfranco Veneto	Veneto
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola	Emilia-Rom
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Lombardia
Italy	Istituto Europeo di Oncologia IRCCS	Milano
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Italy	Azienda Ospedaliera Santa Maria Terni	Terni
Italy	APSS- Presidio Ospedaliero S. Chiara	Trento
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Kimitsu Chuo Hospital	Kisarazu	Chiba
Japan	Kagawa University Hospital	Kita	Kagawa
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	Japanese Red Cross Nagoya Daini Hospital	Nagoya	Aichi
Japan	Osaka City University Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Showa University Hospital	Shinagawa	Tokyo
Japan	Nagano Municipal Hospital	Tomitake	Nagano
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Health Pharma Professional Research S.A. de C.V:	Ciudad de México	Distrito Federal
Mexico	Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.	Culiacan	Sinaloa
Mexico	Actualidad Basada en la Investigación del Cáncer	Guadalajara	Jalisco
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Netherlands	University Medical Center Groningen	Groningen
Netherlands	ETZ Elisabeth	Tilburg	Noord-Brabant
Poland	Szpitale Pomorskie Sp. z o. o.	Gdynia	Pomorskie
Poland	Salve Medica	Lodz	Lódzkie
Poland	Clinical Best Solutions	Lublin	Lubelskie
Poland	Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego	Opole	Opolskie
Poland	Provita Profamilia	Piotrkow Trybunalski	Lódzkie
Romania	Oncopremium Team	Baia Mare	Maramure?
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Centrul medical Focus	Bucure?ti
Romania	Gral Medical Diagnostic Center	Bucure?ti
Romania	Centrul de Oncologie "Sfântul Nectarie"	Craiova	Dolj
Romania	Amethyst Radiotherapy Center	Flore?ti	Cluj
Romania	Radiology Therapeutic Center	Otopeni	Ilfov
Romania	Ovidius Clinical Hospital OCH	Ovidiu	Constan?a
Spain	Hospital Infanta Cristina	Badajoz
Spain	Instituto Catalan de Oncologia - Hospital Duran i Reynals	Hospitalet	Barcelona [Barcelona]
Spain	Hospital General Universitario Gregorio Marañon	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Fundación Instituto Valenciano de Oncología	Valencia	Valenciana, Comunitat
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei City	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center	Adana
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Dicle Üniversitesi	Diyarbakir
Turkey	Trakya University	Edirne
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Izmir Medical Park Hospital	Izmir, Karsiyaka	Izmir
Turkey	Inönü Üniversitesi Turgut Özal Tip Merkezi	Malatya
Turkey	Medipol Mega Universite Hastanesi	Stanbul	Istanbul
United Kingdom	Royal Blackburn Hospital	Blackburn	Blackburn With Darwen
United Kingdom	Colchester General Hospital	Colchester	Essex
United Kingdom	University College London Hospital	London	London, City Of
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Texas Oncology - Balcones	Austin	Texas
United States	MidLantic urology	Bala-Cynwyd	Pennsylvania
United States	Sarah Cannon Research Institute	Baton Rouge	Louisiana
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Maimonides Cancer Center	Brooklyn	New York
United States	The University of Vermont Medical Center Inc.	Burlington	Vermont
United States	Tennessee Oncology Chattanooga-SCRI	Chattanooga	Tennessee
United States	TriState Urologic Services PSC Inc.	Cincinnati	Ohio
United States	Care Access - Clifton	Clifton	New Jersey
United States	UCHealth Memorial Hospital	Colorado Springs	Colorado
United States	Parkland Health and Hospital System	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Texas Oncology - Carrollton	Flower Mound	Texas
United States	UCHealth Harmony	Fort Collins	Colorado
United States	Dwight D Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Florida Cancer Specialists - South	Fort Myers	Florida
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Orange Coast Memorial Medical Center	Fountain Valley	California
United States	Providence Medical Foundation	Fullerton	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Colorado West Healthcare System - Grand Valley Oncology	Grand Junction	Colorado
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Millennium Oncology - Hollywood	Hollywood	Florida
United States	Genesis Cancer and Blood Institute	Hot Springs	Arkansas
United States	Houston Methodist Hospital	Houston	Texas
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Moores Cancer Center	La Jolla	California
United States	USO-Rocky Mountain Cancer Center	Littleton	Colorado
United States	MemorialCare Health System - Long Beach Medical Center	Long Beach	California
United States	Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	UCLA Hematology/Oncology - Santa Monica	Los Angeles	California
United States	The University of Louisville, James Graham Brown Cancer Center	Louisville	Kentucky
United States	Central Georgia Cancer Care	Macon	Georgia
United States	University of Miami Hospital and Clinics, Sylvester Cancer Center	Miami	Florida
United States	Perlmutter Cancer Center at NYU Langone Hospital - Long Island	Mineola	New York
United States	Minnesota Oncology/Hematology PA	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Laura and Isaac Perlmutter Cancer Center	New York	New York
United States	AHN Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Arizona Oncology Associates, P.C. - HOPE	Prescott	Arizona
United States	Arizona Oncology Associates, P.C. - HOPE	Prescott Valley	Arizona
United States	Oncology and Hematology Associates of Southwest Virginia Inc	Roanoke	Virginia
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Urology San Antonio Research	San Antonio	Texas
United States	Candler OncologyMedical Practice	Savannah	Georgia
United States	Highlands Oncology Group	Springdale	Arkansas
United States	USO - Texas Oncology Gulf Coast	Sugar Land	Texas
United States	Associated Medical Professionals - Urology	Syracuse	New York
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	US Oncology Research Network	The Woodlands	Texas
United States	Northwest Cancer Specialist	Tigard	Oregon
United States	Torrance Memorial Physician Network / Cancer Care	Torrance	California
United States	Chesapeake Urology	Towson	Maryland
United States	The University of Arizona Cancer Center - North Campus	Tucson	Arizona
United States	Texas Oncology - Longview Cancer Center	Tyler	Texas
United States	Florida Cancer Specialist- East	West Palm Beach	Florida
United States	Clinical Research Alliance	Westbury	New York
United States	PIH Health Hematology Medical Oncology	Whittier	California
United States	Reliant Medical Group	Worcester	Massachusetts
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Romania,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	rPFS Assessed by Blinded Independent Central Review (BICR)	rPFS Assessed by BICR	Randomization to radiographic progression or death from any cause (approximately 48 months)
Secondary	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)
Secondary	Overall Survival (OS)	OS	Baseline to date of death due to any cause (approximately 60 months)
Secondary	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)
Secondary	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)
Secondary	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)

External 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)