Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Cancer
Prostate Disorders
Treatment
Abiraterone Acetate
Placebo
Abiraterone acetate
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate.
Metastatic prostate cancer documented by positive bone scan and/or measurable softtissue metastatic lesions by CT or magnetic resonance imaging (MRI).
Progressive disease at study entry demonstrated during continuousandrogen-deprivation therapy (ADT)/post orchiectomy defined as one or more of thefollowing:
PSA progression
Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3)for bone, with or without PSA progression
Have adequate organ function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion
Exclusion Criteria:
Prior therapy with cytochrome P450 (CYP)17 inhibitors.
Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6inhibitors.
Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostatecancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, orprior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who hadprior radiation or surgery to all target lesions.
Currently enrolled in a clinical study involving an investigational product.
Gastrointestinal disorder affecting the absorption or ability to swallow largepills.
Clinically significant heart disease, active or chronic liver disease,moderate/severe hepatic impairment (Child-Pugh Class B and C).
Study Design
Connect with a study center
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
AustraliaSite Not Available
Southside Cancer Care Centre
Kogarah, New South Wales 2228
AustraliaSite Not Available
Macquarie University
Macquarie, New South Wales 2109
AustraliaSite Not Available
Macquarie University Hospital
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
Macquarie University
Macquarie University, New South Wales 2109
AustraliaSite Not Available
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
St Vincent's Hospital
Melbourne, Victoria 3065
AustraliaSite Not Available
St. Vincent's Hospital
Melbourne, Victoria 3065
AustraliaSite Not Available
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui 230000
ChinaSite Not Available
Wannan Medical College Yijishan Hospital
Wuhu, Anhui 241001
ChinaSite Not Available
Lanzhou university second hospital
Lanzhou, Gansu 730030
ChinaSite Not Available
Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong 510060
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
Haikou people's hospital
Haikou, Hainan 570206
ChinaSite Not Available
Yijishan Hospital of Wannan Medical College
Wuhu, Hefei 2410000
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150081
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan 471003
ChinaSite Not Available
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, Hubei 430022
ChinaSite Not Available
Wu Han Tongji Hospital
Wuhan City, Hubei 430030
ChinaSite Not Available
Hunan Provincial People's Hospital
ChangSha, Hunan 410005
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaSite Not Available
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
ChinaSite Not Available
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
Nanjing, Jiangsu 210000
ChinaSite Not Available
Nantong Tumor Hospital
Nantong, Jiangsu 226361
ChinaSite Not Available
Wuxi People's Hospital
Wuxi, Jiangsu 214023
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
Jilin Province People's Hospital
Changchun, Jilin 130021
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai, Shandong 264099
ChinaSite Not Available
Yantai Yuhuangding hospital
Yantai, Shandong 264000
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaSite Not Available
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai 20040
ChinaSite Not Available
Huashan Hospital Affiliated Fudan University
Shanghai, Shanghai 200040
ChinaSite Not Available
Nanchong Central Hospital
Nanchong, Sichuan 637000
ChinaSite Not Available
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin 300211
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
Xinjiang Medical University Cancer Hospital
Urumqi, Xinjiang 830000
ChinaSite Not Available
Xinjiang Medical University Cancer Hospital - Urumqi
Urumqi, Xinjiang 830000
ChinaSite Not Available
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaSite Not Available
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 310014
ChinaSite Not Available
Ningbo First Hospital
Ningbo, Zhejiang 315010
ChinaSite Not Available
People's Hospital of Hunan Province
Changsha, 410002
ChinaSite Not Available
Second affiliated hospital of anhui medical university
He Fei, 230000
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'An, 710061
ChinaSite Not Available
Rigshospitalet
Copenhagen, Hovedstaden 2100
DenmarkSite Not Available
Næstved Sygehus
Næstved, Sjælland 4700
DenmarkSite Not Available
Finsen Institute
Copenhagen, 2100
DenmarkSite Not Available
Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-Roussillon 34070
FranceSite Not Available
Clinique Victor Hugo Le Mans
Le Mans, Pays-de-la-Loire 72000
FranceSite Not Available
Centre Leon Berard
Lyon CEDEX 08, Rhône-Alpes 69373
FranceSite Not Available
CHD Vendee
La Roche-sur-Yon, Vendée 85000
FranceSite Not Available
Christophe TOURNIGAND
Créteil, Île-de-France
FranceSite Not Available
Henri Mondor Hospital
Créteil, Île-de-France
FranceSite Not Available
Centre Hospitalier de la Côte Basque
Bayonne, 64109
FranceSite Not Available
CHU de Bordeaux Hop St ANDRE
Bordeaux, 33075
FranceSite Not Available
CHU Henri Mondor
Creteil Cedex, 94010
FranceSite Not Available
CHD Vendee
La Roche Sur Yon, 85025
FranceSite Not Available
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000
FranceSite Not Available
Centre Leon Berard
Lyon Cedex 08, 69373
FranceSite Not Available
Studienpraxis Urologie
Nürtingen, Baden-Württemberg 72622
GermanySite Not Available
Universitaetsklinikum Tuebingen
Tübingen, Baden-Württemberg 72076
GermanySite Not Available
Gesundheitszentrum Holzminden
Holzminden, Niedersachsen 37603
GermanySite Not Available
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Cologne, Nordrhein-Westfalen 50968
GermanySite Not Available
Urologie Neandertal - Praxis Mettmann
Mettmann, Nordrhein-Westfalen 40822
GermanySite Not Available
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Private Practice - Dr. Stammel & Dr. Garcia
Wesel, Nordrhein-Westfalen 46483
GermanySite Not Available
Private Practice - Dr. Silvio Szymula
Leipzig, Sachsen 4105
GermanySite Not Available
Private Practice - Dr. Ralf Eckert
Lutherstadt Eisleben, Sachsen-Anhalt 06295
GermanySite Not Available
Urologie am Nordplatz - Urologische Facharztpraxis Dr. med. Silvio Szymula
Leipzig, Saxony 04105
GermanySite Not Available
Urologische Arztpraxis in Eisleben - Dr. med. Ralf Eckert
Lutherstadt Eisleben, Saxony-Anhalt 06295
GermanySite Not Available
Urologie Bayenthal in Köln
Köln, 50968
GermanySite Not Available
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi 466-8650
JapanSite Not Available
Red Cross Aichi Hospital
Nagoya, Aichi 466-0814
JapanSite Not Available
Hirosaki University Hospital
Hirosaki, Aomori 036-8563
JapanSite Not Available
Toho University Sakura Medical Center
Sakura, Chiba 285-0841
JapanSite Not Available
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
JapanSite Not Available
Kobe City Medical Center General Hospital
Kobe, Hyogo 650-0047
JapanSite Not Available
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
JapanSite Not Available
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
JapanSite Not Available
Saitama Prefectural Cancer Center
Ina-machi, Saitama 362-0806
JapanSite Not Available
Saitama Cancer Center
Kita-Adachi, Saitama 362-0806
JapanSite Not Available
Saitama Prefectural Cancer Center
Kitaadachi-gun, Saitama 362-0806
JapanSite Not Available
Hamamatsu University Hospital
Hamamatsu, Shizuoka 431-3192
JapanSite Not Available
Showa University Hospital
Shinagawa, Tokyo 142-8555
JapanSite Not Available
Showa University Hospital
Shinagawa-ku, Tokyo 142-8666
JapanSite Not Available
Gifu University Hospital
Gifu, 501-1112
JapanSite Not Available
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
JapanSite Not Available
Osaka International Cancer Institute
Osaka, 541-8567
JapanSite Not Available
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 6351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul] 3080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul] 3722
Korea, Republic ofSite Not Available
Asan Medical Center
Songpagu, Seoul-teukbyeolsi [Seoul] 5505
Korea, Republic ofSite Not Available
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland 6532 SZ
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, Zuid-Holland 3015 GD
NetherlandsSite Not Available
Het Nederlands Kanker Instituut - Antoni van Leeuwenhoek
Amsterdam, 1066 CX
NetherlandsSite Not Available
St. Antonius Ziekenhuis, locatie Nieuwegein
Utrecht, 3543 AZ
NetherlandsSite Not Available
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ
NetherlandsSite Not Available
Puerto Rico Hematology/Oncology Group
Bayamon, 00959
Puerto RicoSite Not Available
Gral Medical SRL
Bucuresti, București 031422
RomaniaSite Not Available
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanta, Constanța 900591
RomaniaSite Not Available
Ovidius Clinical Hospital OCH
Ovidiu, Constanța 905900
RomaniaSite Not Available
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj 200542
RomaniaSite Not Available
Radiology Therapeutic Center
Otopeni, Ilfov 075100
RomaniaSite Not Available
Gral Medical Diagnostic Center
București, 31422
RomaniaSite Not Available
Gral Medical SRL
București, 031422
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanta, 900591
RomaniaSite Not Available
'Hospital Virgen de la Victoria
Malaga, Andalucia 29010
SpainSite Not Available
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 8035
SpainSite Not Available
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, Barcelona [Barcelona] 8907
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña] 8036
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad De 28041
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Malaga, Málaga 29010
SpainSite Not Available
Hospital Clinic I Provincial
Barcelona, 08036
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28009
SpainSite Not Available
Derriford Hospital
Plymouth, Devon PL6 8DH
United KingdomSite Not Available
University College Hospital - London
London, Greater London NW1 2BU
United KingdomSite Not Available
Charing Cross Hospital
London, Hammersmith And Fulham W6 8RF
United KingdomSite Not Available
Charing Cross Hospital
Chelsea, London W6 8RF
United KingdomSite Not Available
University College London Hospital
London, London, City Of NW1 2PG
United KingdomSite Not Available
Northampton General Hospital NHS Trust
Northampton, Northamptonshire NN1 5BD
United KingdomSite Not Available
Mayo Clinic Hospital
Phoenix, Arizona 85054
United StatesSite Not Available
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona 85054
United StatesSite Not Available
St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85004
United StatesSite Not Available
University of Arizona Cancer Center
Phoenix, Arizona 85004
United StatesSite Not Available
The University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesSite Not Available
The University of Arizona Cancer Center - North Campus
Tucson, Arizona 85719
United StatesSite Not Available
St. Bernards Medical Center
Jonesboro, Arkansas 72401
United StatesSite Not Available
CBCC Global Research, Inc.
Bakersfield, California 93309
United StatesSite Not Available
Providence St. Jude Medical Center
Fullerton, California 92835
United StatesSite Not Available
St. Joseph Heritage Healthcare
Fullerton, California 92935
United StatesSite Not Available
St. Jude Medical Center
Fullerton, California 92835
United StatesSite Not Available
Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
University of California - San Diego
La Jolla, California 92037
United StatesSite Not Available
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California 90024
United StatesSite Not Available
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California 90095
United StatesSite Not Available
UCLA Medical Center
Los Angeles, California 90024
United StatesSite Not Available
Pacific Cancer Care
Monterey, California 93940
United StatesSite Not Available
Sansum Clinic
Santa Barbara, California 93105
United StatesSite Not Available
Sansum Clinic_Kendle
Santa Barbara, California 93105
United StatesSite Not Available
Sansum Clinic
Solvang, California 93463
United StatesSite Not Available
Rocky Mountain Cancer Center
Denver, Colorado 80218
United StatesSite Not Available
Rocky Mountain Cancer Center
Lone Tree, Colorado 80124
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Millennium Oncology
Hollywood, Florida 33024
United StatesSite Not Available
Millennium Oncology - Hollywood
Hollywood, Florida 33024
United StatesSite Not Available
UF Health Cancer Center- Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
Cancer Care Center of Brevard
Palm Bay, Florida 32909
United StatesSite Not Available
USO-Cancer Care Center of Brevard, Inc.
Palm Bay, Florida 32909
United StatesSite Not Available
Millennium Oncology
Pembroke Pines, Florida 33024
United StatesSite Not Available
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida 34952
United StatesSite Not Available
Northside Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
Northside Hospital Cancer Institute
Marietta, Georgia 30060
United StatesSite Not Available
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana 46804
United StatesSite Not Available
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
Fort Wayne, Indiana 46804
United StatesSite Not Available
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesSite Not Available
Oncology Associates of West Kentucky
Paducah, Kentucky 42003
United StatesSite Not Available
Maryland Oncology Hematology - Columbia
Columbia, Maryland 21044
United StatesSite Not Available
Maryland Oncology Hematology, P.A.
Rockville, Maryland 20850
United StatesSite Not Available
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland 20904
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts 02179
United StatesSite Not Available
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota Hospital
Minneapolis, Minnesota 55455
United StatesSite Not Available
Research Medical Center
Kansas City, Missouri 63142
United StatesSite Not Available
NCCA- National Cancer Care Alliance
Omaha, Nebraska 68130
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89119
United StatesSite Not Available
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
Albany, New York 12206
United StatesSite Not Available
New York Oncology Hematology, P.C
Albany, New York 12208
United StatesSite Not Available
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
Clifton Park, New York 12065
United StatesSite Not Available
NYU Clinical Cancer Center
New York, New York 10016
United StatesSite Not Available
Associated Medical Professionals - Urology
Syracuse, New York 13210
United StatesSite Not Available
Mission SECU Cancer Center
Asheville, North Carolina 28801
United StatesSite Not Available
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma 74146
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma 74146
United StatesSite Not Available
Northwest Cancer Specialists PC
Tigard, Oregon 97223
United StatesSite Not Available
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesSite Not Available
Research Medical Center
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute SCRI
Nashville, Tennessee 37203
United StatesSite Not Available
Southwestern Medical Center - Dallas
Dallas, Texas 75390
United StatesSite Not Available
Texas Oncology Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Oncology-Memorial City
Houston, Texas 77024
United StatesSite Not Available
Texas Oncology - Longview Cancer Center
Longview, Texas 75601
United StatesSite Not Available
Baylor Scott & White Medical Center - Temple
Temple, Texas 76508
United StatesSite Not Available
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
The Woodlands, Texas 77380
United StatesSite Not Available
Northwest Cancer Specialists PC
The Woodlands, Texas 77380
United StatesSite Not Available
Sansum Clinic_Kendle
The Woodlands, Texas 77380
United StatesSite Not Available
Texas Oncology - Longview Cancer Center
The Woodlands, Texas 77380
United StatesSite Not Available
Texas Oncology Cancer Care and Research Center
The Woodlands, Texas 77380
United StatesSite Not Available
Texas Oncology Fort Worth
The Woodlands, Texas 77380
United StatesSite Not Available
Texas Oncology-Memorial City
The Woodlands, Texas 77380
United StatesSite Not Available
US Oncology
The Woodlands, Texas 77380
United StatesSite Not Available
USO-Cancer Care Center of Brevard, Inc.
The Woodlands, Texas 77380
United StatesSite Not Available
Texas Oncology Cancer Care and Research Center
Waco, Texas 76712
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Utah School of Medicine
Salt Lake City, Utah 84132
United StatesSite Not Available
The University of Vermont Medical Center Inc.
Burlington, Vermont 05405
United StatesSite Not Available
University of Vermont Medical Center
Burlington, Vermont 05401
United StatesSite Not Available

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