Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Prostate Cancer
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.
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.
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, androgen receptor signaling inhibitors (ARSi) includingenzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP)monotherapy or other systemic anti-cancer treatment. with the following exceptions:
Treatment with first-generation antiandrogen agents, if discontinued prior torandomization
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
ArgentinaSite Not Available
Hospital Sirio Libanes
Capital Federal, Buenos Aires C1419AHN
ArgentinaSite Not Available
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
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN
ArgentinaSite Not Available
Icon Cancer Centre Wesley
Auchenflower, Queensland 4066
AustraliaSite Not Available
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, SÃO Paulo 09060-650
BrazilSite Not Available
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
ChinaSite Not Available
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
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
ChinaSite Not Available
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
ChinaActive - Recruiting
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 affiliated hospital of Ningbo university
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Multiscan
Pardubice, Pardubický KRAJ 53203
CzechiaSite Not Available
Nukleární Medicína
Hradec Králové, 500 05
CzechiaSite Not Available
Radiodiagnostika Pardubice
Pardubice, 53003
CzechiaSite Not Available
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace 67033
FranceSite Not Available
Istituto Nazionale Tumori Regina Elena
Rome, Roma 00144
ItalySite Not Available
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
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 ofSite Not Available
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul] 07985
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi 41404
Korea, Republic ofSite Not Available
Tergooiziekenhuizen, locatie Hilversum
Hilversum, Noord-holland 1212 VG
NetherlandsSite Not Available
Meander Medisch Centrum
Amersfoort, Utrecht 3813 TZ
NetherlandsActive - Recruiting
MICS Centrum Medyczne Torun
Torun, Kujawsko-pomorskie 87-100
PolandSite Not Available
BEKY - MED, s.r.o.
Presov, 080 01
SlovakiaSite Not Available
MILAB, s.r.o., Urologicka ambulancia
Presov, 08 001
SlovakiaSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña] 08036
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad DE 28034
SpainSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 407
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
TaiwanSite Not Available
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
Colorado Clinical Research
Lakewood, Colorado 80228
United StatesSite Not Available
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
AtlantiCare
Egg Harbor Township, New Jersey 08234
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 StatesSite Not Available
Baptist M&S Imaging (Medical Center)
San Antonio, Texas 78229
United StatesSite Not Available
USA Clinical Trials
San Antonio, Texas 78229
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
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