Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
Placebo
PF-06821497
Enzalutamide
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell features.
Metastatic disease in bone documented on bone scan, or in soft tissue documented onCT/MRI scan.
Progressive disease in the setting of medical or surgical castration.
ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed bythe investigator.
Exclusion
Exclusion Criteria:
Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that make theparticipant inappropriate for the study.
Known history of active inflammatory gastrointestinal disease, chronic diarrhea, orprevious gastric resection or lap-band surgery.
Clinically significant cardiovascular disease.
Known or suspected brain metastasis or active leptomeningeal disease or clinicallysignificant history of seizure.
Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other priormalignancy with a few exceptions.
Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxicchemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptorsignaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, polyADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatmentwith the following exceptions:
Treatment with first-generation antiandrogen (ADT) agents;
Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, ordisease progression occurred during treatment or within 3 months of treatmentcompletion.
Previous administration with an investigational product (drug or vaccine) within 30days or 5 half-lives preceding the first dose of study intervention (whichever islonger).
Inadequate organ function.
Study Design
Study Description
Connect with a study center
Centro de Urología (CDU)
Caba, Buenos Aires C1120AAT
ArgentinaActive - Recruiting
Hospital Sirio Libanes
Capital Federal, Buenos Aires C1419AHN
ArgentinaActive - Recruiting
Imagenes Mdq
Mar del Plata, Buenos Aires B7600FZO
ArgentinaSite Not Available
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires B7600FZO
ArgentinaSite Not Available
Centro Medico Privado CEMAIC
Capital, Córdoba X5008HHW
ArgentinaActive - Recruiting
Hospital Privado Universitario de Córdoba
Cordoba, Córdoba 5016
ArgentinaActive - Recruiting
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN
ArgentinaActive - Recruiting
Centro Medico Fleischer
Buenos Aires,
ArgentinaActive - Recruiting
IMAXE
Buenos Aires, C1120
ArgentinaActive - Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, RIO Grande DO Norte 59062-000
BrazilSite Not Available
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, SÃO Paulo 09060-650
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
Sao Paulo, SÃO Paulo 01327-001
BrazilActive - Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, SÃO Paulo 15090000
BrazilSite Not Available
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
BrazilActive - Recruiting
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
Gabrovo, 5300
BulgariaSite Not Available
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, 5800
BulgariaSite Not Available
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
BulgariaActive - Recruiting
Complex Oncology Center Stara Zagora EOOD
Stara Zagora, 6003
BulgariaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Wannan Medical College Yijishan Hospital
Wuhu, Anhui 241001
ChinaActive - Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing 100021
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaActive - Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong 510180
ChinaSite Not Available
The Second Affiliated Hospital of Shantou University School of Medicine
Shantou, Guangdong 515000
ChinaActive - Recruiting
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi 541199
ChinaSite Not Available
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan 453003
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaActive - Recruiting
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia 010017
ChinaSite Not Available
Huai'an First People's Hospital
Huai'an, Jiangsu 223300
ChinaActive - Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
Nantong Tumor Hospital
Nantong, Jiangsu 226361
ChinaSite Not Available
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
ChinaSite Not Available
Shaanxi Provincial People' Hospital
Xi'an, Shaanxi 710068
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaActive - Recruiting
Shandong Provincial Hospital
Jinan, Shandong 250021
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266003
ChinaActive - Recruiting
Weifang People's Hospital
Weifang, Shandong 261041
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai, Shandong 264099
ChinaSite Not Available
Tongji Hospital of Tongji University
Shanghai, Shanghai 200065
ChinaSite Not Available
West China Hospital, Sichuan University
Cheng Du, Sichuan 610041
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou City, Zhejiang 310016
ChinaSite Not Available
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaActive - Recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang/nanhu 314001
ChinaSite Not Available
Peking University Third Hospital
Beijing, 100191
ChinaActive - Recruiting
First Affiliated Hospital of China Medical University
Shenyang, 110001
ChinaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, Olomoucký KRAJ 779 00
CzechiaSite Not Available
Multiscan
Pardubice, Pardubický KRAJ 53203
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady
PRague, Praha 10 10034
CzechiaSite Not Available
Urocentrum Praha
Prague, Praha 2 120 00
CzechiaActive - Recruiting
Fakultni Thomayerova nemocnice
Prague, Praha 4 14059
CzechiaActive - Recruiting
Næstved Sygehus
Næstved, Sjælland 4700
DenmarkSite Not Available
Vejle Sygehus
Vejle, Syddanmark 7100
DenmarkSite Not Available
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa 33520
FinlandActive - Recruiting
Oulun yliopistollinen sairaala
Oulu, Pohjois-pohjanmaa 90220
FinlandActive - Recruiting
Kuopion Yliopistollinen Sairaala
Kuopio, Pohjois-savo 70210
FinlandActive - Recruiting
Turku University Hospital
Turku, Varsinais-suomi 20520
FinlandActive - Recruiting
Helsinki university hospital
Helsinki, 00290
FinlandActive - Recruiting
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine 33076
FranceActive - Recruiting
CHRU de Brest
Brest, Finistère 29609
FranceSite Not Available
Centre Hospitalier Privé Saint-Grégoire
Saint Grégoire, Ille-et-vilaine 35760
FranceActive - Recruiting
Institut de Cancérologie de l'Ouest
Saint Herblain, Loire-atlantique 44805
FranceSite Not Available
Institut Jean Godinot
Reims, Marne 51726
FranceSite Not Available
Clinique Victor Hugo Le Mans
Le Mans, Pays-de-la-loire 72000
FranceActive - Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône 69310
FranceSite Not Available
Centre Leon Berard
Lyon Cedex08, Rhône-alpes 69373
FranceSite Not Available
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, 63011
FranceSite Not Available
Institut Godinot
Reims, 51100
FranceSite Not Available
Studienpraxis Urologie
Nürtingen, Baden-württemberg 72622
GermanyActive - Recruiting
Universitaetsklinikum Tuebingen
Tübingen, Baden-württemberg 72076
GermanyActive - Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, Nordrhein-westfalen 48149
GermanyActive - Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanyActive - Recruiting
University Hospital of Patras
Patras, Achaḯa 26504
GreeceActive - Recruiting
Alexandra General Hospital of Athens
Athens, Attikí 115 28
GreeceActive - Recruiting
Athens Medical Center
Athens, Attikí 151 25
GreeceActive - Recruiting
Attikon General University Hospital
Chaidari, Attikí 124 62
GreeceActive - Recruiting
University General Hospital of Larissa
Larissa, Thessalía 411 10
GreeceActive - Recruiting
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Borsod-abaúj-zemplén 3526
HungaryActive - Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-romagna 47014
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Lazio 00168
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Roma, Lazio 00144
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, Roma 00144
ItalySite Not Available
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
ItalyActive - Recruiting
Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Azienda Ospedaliera Santa Maria Terni
Terni, 05100
ItalyActive - Recruiting
APSS- Presidio Ospedaliero S. Chiara
Trento, 38122
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, 37134
ItalyActive - Recruiting
Chiba cancer center
Chiba-shi, Chiba 260-8717
JapanActive - Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime 791-0280
JapanActive - Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
JapanActive - Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
JapanActive - Recruiting
Kobe University Hospital
Kobe, Hyogo 650-0017
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
JapanActive - Recruiting
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa 238-8558
JapanActive - Recruiting
Osaka University Hospital
Suita, Osaka 565-0871
JapanActive - Recruiting
The University of Osaka Hospital
Suita, Osaka 565-0871
JapanActive - Recruiting
Keio university hospital
Shinjuku-ku, Tokyo 1608582
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
JapanActive - Recruiting
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
JapanActive - Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
JapanActive - Recruiting
Yamagata University Hospital
Yamagata, 990-9585
JapanActive - Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si, Kyǒnggi-do 10408
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi 41404
Korea, Republic ofActive - Recruiting
Chungnam national university hospital
Jung-gu, Taejǒn-kwangyǒkshi 35015
Korea, Republic ofActive - Recruiting
MICS Centrum Medyczne Torun
Torun, Kujawsko-pomorskie 87-100
PolandSite Not Available
Clinical Best Solutions
Lublin, Lubelskie 20-011
PolandActive - Recruiting
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Kraków, Małopolskie 30-348
PolandActive - Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Kraków, Małopolskie 31-826
PolandActive - Recruiting
Provita Profamilia
Piotrków Trybunalski, Łódzkie 97-300
PolandActive - Recruiting
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, 851 05
SlovakiaActive - Recruiting
Univerzitna nemocnica Martin
Martin, 036 59
SlovakiaActive - Recruiting
Privatna urologicka ambulancia, s.r.o.
Trencin, 911 01
SlovakiaActive - Recruiting
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern CAPE 6045
South AfricaSite Not Available
Wilgers Oncology Centre
Pretoria, Gauteng 0081
South AfricaSite Not Available
Wits Clinical Research
Soweto, Gauteng 2013
South AfricaSite Not Available
TASK Eden
George, Western CAPE 6529
South AfricaSite Not Available
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad DE 28041
SpainSite Not Available
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat 46009
SpainSite Not Available
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Södersjukhuset
Stockholm, Stockholms LÄN [se-01] 11883
SwedenActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 407
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan, 704
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Koç Üniversitesi Hastanesi
İstanbul, İ̇stanbul 34010
TurkeySite Not Available
Memorial Ankara Hastanesi
Ankara, 06520
TurkeySite Not Available
Royal Blackburn Hospital
Blackburn, Blackburn WITH Darwen BB2 3HH
United KingdomActive - Recruiting
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United KingdomSite Not Available
Ironwood Cancer & Research Centers
Chandler, Arizona 85224
United StatesActive - Recruiting
Ironwood Cancer & Research Centers
Gilbert, Arizona 85297
United StatesActive - Recruiting
Ironwood Cancer & Research Centers
Glendale, Arizona 85306
United StatesActive - Recruiting
Palo Verde Hematology Oncology
Glendale, Arizona 85304
United StatesActive - Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona 85202
United StatesActive - Recruiting
Ironwood Cancer & Research Centers
Phoenix, Arizona 85028
United StatesActive - Recruiting
Ironwood Cancer & Research Centers
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Arizona Urology Specialists (AUS)-Orange Grove
Tucson, Arizona 85741
United StatesActive - Recruiting
Arizona Urology Specialists (East Side Location)
Tucson, Arizona 85715
United StatesActive - Recruiting
Highlands Oncology
Fayetteville, Arkansas 72703
United StatesSite Not Available
Highlands Oncology
Rogers, Arkansas 72758
United StatesSite Not Available
Highlands Oncology Group
Springdale, Arkansas 72762
United StatesSite Not Available
Adventist Health Physicians Network
Hidden Valley Lake, California 95467
United StatesActive - Recruiting
Adventist Health Physicians Network
Napa, California 94558
United StatesActive - Recruiting
Adventist Health St. Helena
Saint Helena, California 94574
United StatesActive - Recruiting
Duly Health and Care (Bone Scintigraphy)
Lisle, Illinois 60532
United StatesActive - Recruiting
NextStage Clinical Research-Chicago-(04)
Lisle, Illinois 60532
United StatesActive - Recruiting
Blessing Hospital
Quincy, Illinois 62301
United StatesActive - Recruiting
Blessing Physician Services
Quincy, Illinois 62301
United StatesActive - Recruiting
Duly Health and Care (CT and MRI)
Westmont, Illinois 60559
United StatesActive - Recruiting
Adult & Pediatric Urology, PC
Omaha, Nebraska 68114
United StatesSite Not Available
Montefiore Medical Center - Medical Park
Bronx, New York 10461
United StatesSite Not Available
Salisbury VA Medical Center
Salisbury, North Carolina 28144
United StatesSite Not Available
AUC Urologists, LLC
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Grand Strand Medical Center
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
USA Clinical Trials
San Antonio, Texas 78229
United StatesSite Not Available
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesSite Not Available
Harborview Medical Center
Seattle, Washington 98104
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesSite Not Available
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