Phase
Condition
Prostate Cancer
Urologic Cancer
Prostate Cancer, Early, Recurrent
Treatment
Docetaxel
Enzalutamide
PF-06821497
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 surgical or medical castration with evidenceof disease progression on treatment with abiraterone acetate in the mCSPC setting orfirst line mCRPC setting is required.
Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with lifeexpectancy of at least 6 months as assessed by the investigator.
Exclusion
Exclusion Criteria:
Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may make theparticipant inappropriate for the study.
Know 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.
Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy,radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signalinginhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribosepolymerase (PARP) monotherapy or other systemic anti-cancer treatment, with thefollowing exceptions:
Treatment with first-generation antiandrogen agents, if discontinued prior tofirst dose of study intervention.
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 within 30 days or 5half-lives preceding the first dose of study intervention (whichever is shorter).
Inadequate organ function.
Study Design
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 7600
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
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN
ArgentinaActive - Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO
ArgentinaSite Not Available
IMAXE
Buenos Aires, C1120
ArgentinaActive - Recruiting
Icon Cancer Centre Wesley
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, RIO Grande DO SUL 90610-000
BrazilActive - Recruiting
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
BrazilSite Not Available
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
BrazilActive - Recruiting
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221-020
BrazilActive - Recruiting
Wannan Medical College Yijishan Hospital
Wuhu, Anhui 241001
ChinaSite Not Available
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing 100191
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, Chongqing 400030
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Lanzhou university second hospital
Lanzhou, Gansu 730030
ChinaActive - Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong 510180
ChinaSite Not Available
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong 510515
ChinaSite Not Available
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi 541199
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
Huai'an First People's Hospital
Huai'an, Jiangsu 223300
ChinaSite Not Available
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
ChinaSite Not Available
Nantong Tumor Hospital
Nantong, Jiangsu 226361
ChinaActive - Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
ChinaActive - Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
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
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, Zhejiang 310016
ChinaActive - Recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang 314001
ChinaActive - Recruiting
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, Olomoucký KRAJ 779 00
CzechiaSite Not Available
Multiscan
Pardubice, Pardubický KRAJ 53203
CzechiaActive - Recruiting
Fakultni nemocnice Kralovske Vinohrady
PRague, Praha 10 10034
CzechiaSite Not Available
Fakultni Thomayerova nemocnice
Prague, Praha 4 14059
CzechiaActive - Recruiting
Nukleární Medicína
Hradec Králové, 500 05
CzechiaActive - Recruiting
Radiodiagnostika Pardubice
Pardubice, 53003
CzechiaActive - Recruiting
Centre Antoine Lacassagne
Nice, Alpes-maritimes 06189
FranceSite Not Available
Centre Antoine-Lacassagne
Nice, Alpes-maritimes 06189
FranceSite Not Available
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace 67033
FranceActive - Recruiting
CHRU de Brest
Brest, Finistère 29609
FranceSite Not Available
Oncopole Claudius Regaud
Toulouse, Haute-garonne 31059
FranceSite Not Available
Hôpital Foch
Suresnes, Hauts-de-seine 92151
FranceActive - Recruiting
Centre Hospitalier Privé Saint-Grégoire
Saint Grégoire, Ille-et-vilaine 35760
FranceActive - Recruiting
Institut Jean Godinot
Reims, Marne 51726
FranceSite Not Available
Centre Leon Berard
Lyon Cedex08, Rhône-alpes 69373
FranceSite Not Available
Gustave Roussy
Villejuif, Val-de-marne 94800
FranceSite Not Available
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, 63011
FranceSite Not Available
Studienpraxis Urologie
Nürtingen, Baden-württemberg 72622
GermanyActive - Recruiting
Universitaetsklinikum Tuebingen
Tübingen, Baden-württemberg 72076
GermanyActive - Recruiting
Urologie Neandertal - Praxis Mettmann
Mettmann, Nordrhein-westfalen 40822
GermanyActive - Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, Nordrhein-westfalen 48149
GermanyActive - Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanyActive - Recruiting
Alexandra General Hospital of Athens
Athens, Attikí 115 28
GreeceSite Not Available
Athens Medical Center
Athens, Attikí 151 25
GreeceActive - Recruiting
Metropolitan General Hospital
Athens, Attikí 155 62
GreeceActive - Recruiting
Attikon General University Hospital
Chaidari, Attikí 124 62
GreeceSite Not Available
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-romagna 47014
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Roma, Lazio 00144
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, Roma 00144
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Chiba cancer center
Chiba-shi, Chiba 260-8717
JapanActive - Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
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 ofActive - Recruiting
National Cancer Center
Goyang-si, Kyǒnggi-do 10408
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 05505
Korea, Republic ofActive - Recruiting
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul] 07985
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
Frisius Medisch Centrum
Leeuwarden, Fryslân 8934 AD
NetherlandsSite Not Available
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland 6532 SZ
NetherlandsActive - Recruiting
Tergooiziekenhuizen, locatie Hilversum
Hilversum, Noord-holland 1212 VG
NetherlandsActive - Recruiting
Meander Medisch Centrum
Amersfoort, Utrecht 3813 TZ
NetherlandsActive - Recruiting
MICS Centrum Medyczne Torun
Torun, Kujawsko-pomorskie 87-100
PolandSite Not Available
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
PolandSite Not Available
BEKY - MED, s.r.o.
Presov, 080 01
SlovakiaActive - Recruiting
MILAB, s.r.o., Urologicka ambulancia
Presov, 08 001
SlovakiaActive - Recruiting
Fakultna nemocnica Trnava
Trnava, 917 02
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
TASK Eden
George, Western CAPE 6529
South AfricaSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña] 08036
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña] 08041
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad DE 28041
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad DE 28034
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, 8423
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
València, 46026
SpainSite Not Available
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
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
TaiwanActive - Recruiting
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
Urology Centers of Alabama
Homewood, Alabama 35209
United StatesActive - Recruiting
Arizona Urology Specialists (AUS)-Orange Grove
Tucson, Arizona 85741
United StatesActive - Recruiting
Arizona Urology Specialists- Provide ICF for Review Only
Tucson, Arizona 85715
United StatesActive - Recruiting
Sutter Santa Rosa
Santa Rosa, California 95403
United StatesActive - Recruiting
Colorado Clinical Research
Lakewood, Colorado 80228
United StatesActive - Recruiting
Florida Cancer Specialists
Bonita Springs, Florida 34135
United StatesActive - Recruiting
Florida Cancer Specialists
Bradenton, Florida 34211
United StatesActive - Recruiting
Florida Cancer Specialists
Cape Coral, Florida 33909
United StatesActive - Recruiting
Florida Cancer Specialists
Fort Myers, Florida 33908
United StatesActive - Recruiting
Florida Cancer Specialists
Naples, Florida 34102
United StatesActive - Recruiting
Florida Cancer Specialists
Port Charlotte, Florida 33980
United StatesActive - Recruiting
Florida Cancer Specialists
Sarasota, Florida 34236
United StatesActive - Recruiting
Florida Cancer Specialists
Venice, Florida 34292
United StatesActive - Recruiting
Duly Health and Care
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Duly Health And Care
Lisle, Illinois 60532
United StatesActive - Recruiting
NextStage Clinical Research-Chicago-(04)
Lisle, Illinois 60532
United StatesActive - Recruiting
Duly Health and Care
Westmont, Illinois 60559
United StatesActive - Recruiting
The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky 40202
United StatesSite Not Available
University of Louisville Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
United StatesSite Not Available
AtlantiCare
Egg Harbor Township, New Jersey 08234
United StatesActive - Recruiting
James J. Peters VA Medical Center
Bronx, New York 10468
United StatesSite Not Available
Salisbury VA Medical Center
Salisbury, North Carolina 28144
United StatesSite Not Available
Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United StatesActive - Recruiting
AUC Urologists, LLC
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Grand Strand Medical Center
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Baptist M&S Imaging (Medical Center)
San Antonio, Texas 78229
United StatesSite Not Available
USA Clinical Trials
San Antonio, Texas 78229
United StatesActive - Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
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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