DDR 유전자 돌연변이 mCSPC를 가진 남성에서 Enzalutamide와 Talazoparib의 연구
TALAPRO-3: DDR 유전자 변이 전이성 거세 민감성 전립선암 환자를 대상으로 엔잘루타미드와 위약을 병용한 talazoparib와 엔잘루타마이드를 병용한 3상, 무작위 이중 맹검 연구
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up.
Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:
- Talazoparib in combination with enzalutamide.
- Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide.
Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Gauteng
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Johannesburg, Gauteng, 남아프리카, 2193
- Charlotte Maxeke Johannesburg Academic Hospital
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Johannesburg, Gauteng, 남아프리카, 2193
- 15 Eton Road
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Johannesburg, Gauteng, 남아프리카, 2193
- WCR Office
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Johannesburg, Gauteng, 남아프리카, 2196
- Sandton Oncology Medical Group (Pty) Ltd
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Parktown, Gauteng, 남아프리카, 2193
- Wits Clinical Research
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Pretoria, Gauteng, 남아프리카, 0002
- Clinical Research Unit, University of Pretoria
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The Hague, 네덜란드, 2545 AA
- Stichting HagaZiekenhuis
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Utrecht
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Amersfoort, Utrecht, 네덜란드, 3813 TZ
- Meander Medisch Centrum
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Gjøvik, 노르웨이, 2819
- Sykehuset Innlandet Gjoevik
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Kaohsiung City, 대만, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Tainan, 대만, 704
- National Cheng Kung University Hospital
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Taipei, 대만, 10002
- National Taiwan University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taoyuan City, 대만, 333
- Linkou Chang Gung Memorial Hospital
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Daegu, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Seoul, 대한민국, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
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Seoul, 대한민국, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 07985
- Ewha Womans University Mokdong Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, 대한민국, 10408
- National Cancer Center
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Jeollanam-do
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Hwasun-gun, Jeollanam-do, 대한민국, 58128
- Chonnam National University Hwasun Hospital
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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Berlin, 독일, 10117
- Charite Universitaetsmedizin Berlin - Campus Mitte
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Duisburg, 독일, 47169
- Urologicum Duisburg
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Frankfurt, 독일, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, 독일, 37075
- Institut fuer Diagnostische und Interventionelle Radiologie
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Göttingen, 독일, 37075
- Klinik fuer Nuklearmedizin
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Heidelberg, 독일, 69120
- Universitaetsklinik Heidelberg
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Leipzig, 독일, 04105
- Uro-/Onkologisches Zentrum
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Nürtingen, 독일, 72622
- Studienpraxis Urologie
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Tübingen, 독일, 72076
- Universitaetsklinikum Tuebingen
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Lower Saxony
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Göttingen, Lower Saxony, 독일, 37075
- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Wesel, North Rhine-Westphalia, 독일, 46483
- Urologische Gemeinschaftspraxis Wesel
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Thuringia
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Jena, Thuringia, 독일, 07747
- Universitätsklinikum Jena
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Chelyabinsk, 러시아 제국, 454048
- Evimed Llc
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Chelyabinsk, 러시아 제국, 454087
- SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
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Ivanovo, 러시아 제국, 153040
- Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
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Moscow, 러시아 제국, 117997
- Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
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Moscow, 러시아 제국, 121205
- Branch of the Limited Liability Company "Hadassah Medical Ltd."
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Moscow, 러시아 제국, 121359
- Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
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Omsk, 러시아 제국, 644013
- BHI of Omsk region "Clinical Oncological Dispensary"
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Saint Petersburg, 러시아 제국, 191025
- LLC "Medicina Severnoy Stolitsy"
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Saint Petersburg, 러시아 제국, 192007
- LLC "Severo-Zapadny Medical Center"
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Samara, 러시아 제국, 443011
- Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
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Ufa, 러시아 제국, 450054
- SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
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Vologda, 러시아 제국, 160002
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
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Vologda, 러시아 제국, 160022
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
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Yaroslavl, 러시아 제국, 150054
- State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
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Kaluga Oblast
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Obninsk, Kaluga Oblast, 러시아 제국, 249036
- MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
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Sankt-Peterburg
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Pushkin, Sankt-Peterburg, 러시아 제국, 196603
- Private Medical Institution "Euromedservice"
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Stavropol Kray
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Pyatigorsk, Stavropol Kray, 러시아 제국, 357502
- Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
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Oaxaca City, 멕시코, 68020
- Centro de Investigacion Clinica de Oaxaca
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Veracruz, 멕시코, 91851
- Instituto Veracruzano en Investigación Clínica S.C.
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Guanajuato
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León, Guanajuato, 멕시코, 37178
- Preparaciones Oncológicas S.C.
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Nuevo León
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Monterrey, Nuevo León, 멕시코, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Monterrey, Nuevo León, 멕시코, 64040
- Axis Heilsa S. de R.L. de C.V.
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Oaxaca
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Oaxaca City, Oaxaca, 멕시코, 68000
- Oaxaca Site Management Organization
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State of Mexico
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Naucalpan, State of Mexico, 멕시코, 53100
- Oncologia Integral Satelite SA de CV
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham
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Birmingham, Alabama, 미국, 35249
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, 미국, 85704
- Arizona Institute of Urology, PLLC
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California
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Beverly Hills, California, 미국, 90211
- Beverly Hills Cancer Center
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Glendale, California, 미국, 91206
- Adventist Health Glendale
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Long Beach, California, 미국, 90822
- VA Long Beach Healthcare System
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale-New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, 미국, 20010
- Washington Cancer Institute at MedStar Washington Hospital Center
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Florida
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Orlando, Florida, 미국, 32804
- Investigational Drug Services, Advent Health Orlando
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Orlando, Florida, 미국, 32804
- AdventHealth Medical Group Hematology and Oncology
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Georgia
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Austell, Georgia, 미국, 30106
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
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Austell, Georgia, 미국, 30106
- Wellstar Cobb Hospital
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Carrollton, Georgia, 미국, 30117
- Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
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Carrollton, Georgia, 미국, 30117
- West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
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Cartersville, Georgia, 미국, 30121
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
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Douglasville, Georgia, 미국, 30134
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
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Marietta, Georgia, 미국, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
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Illinois
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Lake Barrington, Illinois, 미국, 60010
- Comprehensive Urologic Care, SC
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Normal, Illinois, 미국, 61761
- Mid-Illinois Hematology & Oncology Associates, Ltd
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Health System
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Detroit, Michigan, 미국, 48202
- Henry Ford Medical Center - New Center One
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Farmington Hills, Michigan, 미국, 48334
- Revive Research Institute, Inc.
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Missouri
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St Louis, Missouri, 미국, 63141
- David C. Pratt Cancer Center
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New Jersey
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Belleville, New Jersey, 미국, 07109
- New Jersey Cancer Care, P.A.
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New York
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Poughkeepsie, New York, 미국, 12603
- Premier Medical Group of the Hudson Valley PC
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Oregon
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Portland, Oregon, 미국, 97213
- Providence Cancer Institute Franz Clinic
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Portland, Oregon, 미국, 97213
- Providence Portland Medical Center
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Pennsylvania
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Lancaster, Pennsylvania, 미국, 17604
- Keystone Urology Specialists
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South Carolina
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Myrtle Beach, South Carolina, 미국, 29572
- Carolina Urologic Research Center, LLC
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Tennessee
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Bristol, Tennessee, 미국, 37620
- Bristol Regional Medical Center
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Kingsport, Tennessee, 미국, 37660
- Ballad Health Cancer Care - Kingsport
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Kingsport, Tennessee, 미국, 37660
- Indian Path Community Hospital
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Kingsport, Tennessee, 미국, 37660
- Holston Valley Hospital and Medical Center
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Texas
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Houston, Texas, 미국, 77005
- Kelsey Research Foundation
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Houston, Texas, 미국, 77025
- Kelsey-Seybold Clinic
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Houston, Texas, 미국, 77027
- Houston Metro Urology
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Houston, Texas, 미국, 77008
- Oncology Consultants, P.A.
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Houston, Texas, 미국, 77030
- Oncology Consultants P.A.
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Houston, Texas, 미국, 77014
- Kelsey-Seybold Clinic
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Houston, Texas, 미국, 77055
- Kelsey-Seybold Clinic
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Houston, Texas, 미국, 77024
- oncology Consultants, P.A.
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San Antonio, Texas, 미국, 78229
- Urology San Antonio
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Webster, Texas, 미국, 77598
- Texas Oncology-Deke Slayton Cancer Center
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Utah
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Salt Lake City, Utah, 미국, 84112
- Huntsman Cancer Institute - University of Utah
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Aalst, 벨기에, 9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Anderlecht, 벨기에, 1070
- Institut Jules Bordet
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Brussels, 벨기에, 1200
- Cliniques universitaires Saint-Luc
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Brussels, 벨기에, 1000
- Institut Jules Bordet
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Ghent, 벨기에, 9000
- AZ (Algemeen Ziekenhuis) Maria Middelares
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Ghent, 벨기에, 9000
- AZ (Algemeen Ziekenhuis) Sint-Lucas
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Kortrijk, 벨기에, 8500
- AZ (Algemeen Ziekenhuis) Groeninge
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Liège, 벨기에, 4000
- CHU de Liege
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Merksem, 벨기에, 2170
- ZNA Jan Palfijn
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Panagyurishte, 불가리아, 4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD
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Plovdiv, 불가리아, 4000
- Complex Oncology Center - Plovdiv EOOD
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Plovdiv, 불가리아, 4000
- Independent medical-diagnostic laboratory "Medisken" EOOD
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Plovdiv, 불가리아, 4000
- Complex Oncology Center- Plovdiv EOOD
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Shumen, 불가리아, 9700
- Complex Oncology Center - Shumen EOOD
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Sofia, 불가리아, 1407
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
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Sofia, 불가리아
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
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Stara Zagora, 불가리아, 6003
- Complex Oncology Center - Stara Zagora Ltd.
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Stara Zagora, 불가리아, 6003
- MRI SMDLOD "Mediscan" Ltd
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Stara Zagora, 불가리아, 6003
- UMHAT "Prof. Dr. Stoyan Kirkovich"
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, 스페인, 08036
- Hospital Clínic de Barcelona
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Córdoba, 스페인, 14004
- Hospital Universitario Reina Sofía
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Madrid, 스페인, 28033
- MD Anderson Cancer Center
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Madrid, 스페인, 28009
- Hospital Universitario Gregorio Marañón
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Seville, 스페인, 41009
- Hospital Universitario Virgen de la Macarena
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Valencia, 스페인, 46026
- Hospital Politecnic Universitari La Fe
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Alicante
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Elche, Alicante, 스페인, 03203
- Hospital General Universitario de Elche
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, 스페인, 08908
- Institut Català d'Oncologia de l'Hospitalet
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Manresa, Barcelona, 스페인, 08243
- Althaia, Xarxa Assistencial Universitària de Manresa
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Barcelona [barcelona]
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Badalona, Barcelona [barcelona], 스페인, 08916
- Hospital Germans Trias i Pujol
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Galicia
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Lugo, Galicia, 스페인, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Comunidad de
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Majadahonda, Madrid, Comunidad de, 스페인, 28222
- Hospital Universitario Puerta de Hierro
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Navarre
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Pamplona, Navarre, 스페인, 31008
- Complejo Hospitalario de Navarra
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Principality of Asturias
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Oviedo, Principality of Asturias, 스페인, 33011
- Hospital Universitario Central de Asturias
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Tarragona
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Reus, Tarragona, 스페인, 43204
- Hospital Universitari Sant Joan de Reus
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, 스페인, 46009
- Fundación Instituto Valenciano de Oncología
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Banská Bystrica, 슬로바키아, 975 17
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
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Bratislava, 슬로바키아, 833 10
- Narodny onkologicky ustav
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Košice, 슬로바키아, 041 91
- Vychodoslovensky onkologicky ustav, a.s.
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Nitra, 슬로바키아, 949 01
- UROEXAM, spol. s r.o.
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Poprad, 슬로바키아, 058 01
- POKO Poprad s.r.o.
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Prešov, 슬로바키아, 08001
- MILAB s.r.o.
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Trenčín, 슬로바키아, 911 01
- Privatna urologicka ambulancia, s.r.o.
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-
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-
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CABA, 아르헨티나, C1426ANZ
- Instituto Médico Especializado Alexander Fleming
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Caba, 아르헨티나, C1426AGE
- Centro Oncologico Korben
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Córdoba, 아르헨티나, X5008HHW
- Centro Medico Privado CEMAIC
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Buenos Aires
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Berazategui, Buenos Aires, 아르헨티나, B1884BBF
- COIBA
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Pergamino, Buenos Aires, 아르헨티나, B2700CPM
- Centro de Investigacion Pergamino SA - Clinica Pergamino SA
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Río Negro Province
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Viedma, Río Negro Province, 아르헨티나, R8500ACE
- Centro de Investigaciones Clínicas - Clínica Viedma
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, 아르헨티나, T4000IAK
- Centro Medico San Roque
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-
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Birmingham, 영국, B9 5SS
- University Hospitals Birmingham NHS Foundation Trust
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Glasgow, 영국, G12 0YN
- NHS Greater Glasgow and Clyde
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London, 영국, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
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London, 영국, W6 8RF
- Imperial College Healthcare NHS Trust
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Manchester, 영국, M20 4BX
- The Christie NHS Foundation Trust
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Devon
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Exeter, Devon, 영국, EX2 5DW
- Royal Devon and Exeter NHS Foundation Trust
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KENT
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Maidstone, KENT, 영국, ME16 9QQ
- Maidstone and Tunbridge Wells NHS Trust
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Lancashire
-
Preston, Lancashire, 영국, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust
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Midlothian
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Edinburgh, Midlothian, 영국, EH4 2XU
- NHS Lothian
-
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Scotland
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Glasgow, Scotland, 영국, G12 0XH
- Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
-
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South Yorkshire
-
Sheffield, South Yorkshire, 영국, S10 2SJ
- Sheffield Teaching Hospitals NHS Foundation Trust
-
-
-
-
-
Dnipro, 우크라이나, 49102
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
-
Dnipro, 우크라이나, 49005
- Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
-
Kharkiv, 우크라이나, 61070
- Communal Non-Profit Enterprise "Regional Center of Oncology"
-
Kharkiv, 우크라이나, 61037
- Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
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Lviv, 우크라이나, 79031
- Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
-
-
Dnipropetrovsk Oblast
-
Kryviy Rih, Dnipropetrovsk Oblast, 우크라이나, 50048
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
-
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Kyiv Oblast
-
Pliuty Village, Kyiv Oblast, 우크라이나, 08720
- Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
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Kyivska Oblast
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Khodosovka, Kyivska Oblast, 우크라이나, 08173
- Asklepion Medical Center
-
Kyiv, Kyivska Oblast, 우크라이나, 03022
- National Cancer Institute
-
-
-
-
-
Arezzo, 이탈리아, 52100
- Ospedale San Donato
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Arezzo, 이탈리아, 52100
- Azienda Unita Sanitaria Locale Toscana Sud-Est
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Bari, 이탈리아, 70124
- IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
-
Bergamo, 이탈리아, 24127
- ASST Papa Giovanni XXIII
-
Brescia, 이탈리아, 25123
- ASST degli Spedali Civili de Brescia
-
Orbassano, 이탈리아, 10043
- Azienda Ospedaliera Universitaria San Luigi Gonzaga- Uinta di Oncologia Polmonare
-
Verona, 이탈리아, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
BO
-
Bologna, BO, 이탈리아, 40138
- Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
-
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CR
-
Cremona, CR, 이탈리아, 26100
- ASST Cremona
-
-
FC
-
Meldola, FC, 이탈리아, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
-
-
FG
-
San Giovanni Rotondo, FG, 이탈리아, 71013
- Fondazione Casa Sollievo della Sofferenza
-
-
Naples
-
Naples, Naples, 이탈리아, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
-
-
PN
-
Aviano, PN, 이탈리아, 33081
- Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
-
-
TN
-
Trento, TN, 이탈리아, 38122
- Ospedale Santa Chiara
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, 이탈리아, 38123
- Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento
-
-
-
-
-
New Delhi, 인도, 600028
- Indraprastha Apollo Hospitals
-
-
Gujarat
-
Surat, Gujarat, 인도, 395009
- Gujarat Hospital - Gastro and Vascular Centre
-
-
Haryana
-
Gurugram, Haryana, 인도, 122001
- Medanta- The Medicity hospital
-
Gurugram, Haryana, 인도, 122001
- Artemis hospital
-
-
Maharashtra
-
Mumbai, Maharashtra, 인도, 401107
- Bhaktivedanta Hospital and Research Institute
-
Pune, Maharashtra, 인도, 411004
- Sahyadri Super Speciality Hospital
-
Pune, Maharashtra, 인도, 411004
- Sahyadri Clinical Research & Development Centre
-
Pune, Maharashtra, 인도, 411038
- Sahyadri Hospitals Private Limited
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, 인도, 110076
- Indraprastha Apollo Hospital
-
New Delhi, National Capital Territory of Delhi, 인도, 110085
- Rajiv Gandhi Cancer Institute and Research Centre
-
-
Uttar Pradesh
-
Meerut, Uttar Pradesh, 인도, 250001
- Valentis Cancer Hospital
-
-
West Bengal
-
Kolkata, West Bengal, 인도, 700094
- Netaji Subhas Chandra Bose Cancer Hospital
-
-
-
-
-
Kagoshima, 일본, 890-8520
- Kagoshima University Hospital
-
Kumamoto, 일본, 860-0008
- National Hospital Organization Kumamoto Medical Center
-
Tokushima, 일본, 770-8503
- Tokushima University Hospital
-
Yamagata, 일본, 990-9585
- Yamagata University Hospital
-
-
Aichi-ken
-
Nagoya, Aichi-ken, 일본, 466-8560
- Nagoya University Hospital
-
-
Aomori
-
Hirosaki, Aomori, 일본, 036-8563
- Hirosaki University School of Medicine & Hospital
-
-
Chiba
-
Chiba, Chiba, 일본, 2608717
- Chiba cancer center
-
Kashiwa, Chiba, 일본, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, 일본, 791-0280
- National Hospital Organization Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, 일본, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Hiroshima
-
Kure, Hiroshima, 일본, 737-0023
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center
-
-
Hokkaido
-
Sapporo, Hokkaido, 일본, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
Sapporo, Hokkaido, 일본, 060-8648
- Hokkaido University Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, 일본, 920-8641
- Kanazawa University Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, 일본, 232-0024
- Yokohama City University Medical Center
-
Yokosuka, Kanagawa, 일본, 238-8558
- Yokosukakyosai
-
-
Osaka
-
Osaka, Osaka, 일본, 5418567
- Osaka International Cancer Institute
-
Sakai, Osaka, 일본, 590-0197
- Kindai University Hospital
-
Suita, Osaka, 일본, 565-0871
- The University of Osaka Hospital
-
-
Shizuoka
-
Hamamatsu, Shizuoka, 일본, 431-3192
- Hamamatsu University Hospital
-
-
Tokyo
-
Meguro-Ku, Tokyo, 일본, 152-8902
- National Hospital Organization Tokyo Medical Center
-
Shinjuku-ku, Tokyo, 일본, 160-8582
- Keio university hospital
-
-
-
-
-
Chongqing, 중국, 400042
- The First Affiliated Hospital Chongqing Medical University
-
Guangzhou, 중국, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Anhui
-
Hefei, Anhui, 중국, 230022
- The First Affiliated Hospital of Anhui Medical University
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100034
- Peking University First Hospital
-
-
Gansu
-
Lanzhou, Gansu, 중국, 730030
- Lanzhou university second hospital
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510515
- Nanfang Hospital of Southern Medical University
-
Guangzhou, Guangdong, 중국, 510230
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Henan
-
Zhengzhou, Henan, 중국, 450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, 중국, 430079
- Hubei Cancer Hospital
-
Wuhan, Hubei, 중국, 430022
- Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
-
Wuhan, Hubei, 중국, 430030
- Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
-
-
Hunan
-
Changsha, Hunan, 중국, 410013
- Hunan Cancer Hospital
-
Changsha, Hunan, 중국, 410013
- The Third Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210009
- Zhongda Hospital Southeast University
-
Nantong, Jiangsu, 중국, 226000
- Nantong Tumor Hospital
-
Suzhou, Jiangsu, 중국, 215004
- The Second Affiliated Hospital of Soochow University
-
-
Jiangxi
-
Nanchang, Jiangxi, 중국, 330029
- Jiangxi Provincial Cancer Hospital
-
-
Jilin
-
Changchun, Jilin, 중국, 130021
- The First hospital of Jilin University
-
-
Shaanxi
-
Xi'an, Shaanxi, 중국, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200032
- Fudan University Cancer Hospital
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610041
- West China Hospital of Sichuan University
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, 중국, 300211
- The Second Hospital of Tianjin Medical University
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310014
- Zhejiang Provincial People's Hospital
-
Ningbo, Zhejiang, 중국, 315010
- The first affiliated hospital of Ningbo university
-
Wenzhou, Zhejiang, 중국, 325000
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
-
Olomouc, 체코, 779 00
- Fakultni nemocnice Olomouc
-
Ostrava - Poruba, 체코, 708 52
- Fakultni nemocnice Ostrava
-
Prague, 체코, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, 체코, 150 00
- Fakultni Nemocnice Motol a Homolka
-
Praha 8- Liben, 체코, 180 81
- Fakultni nemocnice Bulovka
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2V 1P9
- Prostate Cancer Centre
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다, B3H 2Y9
- Centre of Applied Urology Research, Nova Scotia Health Authority
-
-
Ontario
-
London, Ontario, 캐나다, N6A 5W9
- London Health Sciences Centre
-
London, Ontario, 캐나다, N6C2R5
- Organisation Lawson Health Research Institute
-
Ottawa, Ontario, 캐나다, K1H 8L6
- The Ottawa Hospital Cancer Center
-
Toronto, Ontario, 캐나다, M5G 2M9
- University Health Network-Princess Margaret Cancer Centre
-
-
Quebec
-
Chicoutimi, Quebec, 캐나다, G7H 5H6
- CIUSSS- saguenay-Lac-Saint-Jean
-
Chicoutimi, Quebec, 캐나다, G7H 7K9
- Centre integre universitaire de sante et de services sociaux Saguenay-Lac-Saint-Jean
-
Greenfield Park, Quebec, 캐나다, J4V 2H3
- Urology South Shore Research
-
Montreal, Quebec, 캐나다, H3T 1E2
- Jewish General Hospital
-
Montreal, Quebec, 캐나다, H4A 3J1
- McGill University Health Center
-
Montreal, Quebec, 캐나다, H2X 0A9
- Centre Hospitalier de I'Universite de Montreal (CHUM)
-
Montreal, Quebec, 캐나다, H2X 0A9
- CHUM - Centre Hospitalier de l'Université de Montréal
-
-
-
-
-
Adana, 터키 (Türkiye), 01415
- Adana City Training and Research Hospital
-
Ankara, 터키 (Türkiye), 06620
- Ankara University Faculty of Medicine
-
Ankara, 터키 (Türkiye), 06800
- Ankara City Hospital
-
Edirne, 터키 (Türkiye), 22030
- Trakya University Medical Faculty
-
Istanbul, 터키 (Türkiye), 34098
- Istanbul University, Cerrahpasa Faculty of Medicine
-
Istanbul, 터키 (Türkiye), 34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Malatya, 터키 (Türkiye), 44280
- Inonu University, Faculty of Medicine
-
-
-
-
-
Angers, 프랑스, 49933
- Centre Hospitalier Universitaire d'Angers
-
Bayonne, 프랑스, 64100
- Clinique Belharra
-
Lille, 프랑스, 59000
- Hopital Prive le Bois
-
Lyon, 프랑스, 69373
- Centre Leon Berard
-
Paris, 프랑스, 75018
- Hopital Bichat - Claude Bernard
-
Paris, 프랑스, 75877
- Hopital Bichat - Claude Bernard
-
Pierre-Bénite, 프랑스, 69310
- Hopital Lyon Sud
-
Quint-Fonsegrives, 프랑스, 31130
- Clinique La Croix du Sud - Ramsay Sante
-
Reims, 프랑스, 51726
- Institut Jean Godinot
-
Saint-Grégoire, 프랑스, 35760
- CHP Saint-Grégoire
-
Strasbourg, 프랑스, 67200
- Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
-
Vandœuvre-lès-Nancy, 프랑스, 54519
- Institut de cancerologie de Lorraine
-
Villejuif, 프랑스, 94805
- Gustave Roussy
-
-
Brittany Region
-
Brest, Brittany Region, 프랑스, 29200
- CHU Morvan de Brest
-
-
Pays de la Loire Region
-
Le Mans, Pays de la Loire Region, 프랑스, 72000
- Clinique Victor Hugo Le Mans
-
-
Île-de-France Region
-
Créteil, Île-de-France Region, 프랑스, 94010
- Hopital Henri Mondor
-
-
-
-
-
Helsinki, 핀란드, 00029
- Helsinki University Hospital
-
Helsinki, 핀란드, 00180
- Docrates Cancer Center
-
Helsinki, 핀란드, 00280
- Clinical Research Institute Helsinki University Central Hospital Ltd
-
Kuopio, 핀란드, 70210
- Kuopio University Hospital
-
Tampere, 핀란드, 33520
- Tampere University Hospital
-
Turku, 핀란드, 20520
- Turku University Hospital
-
-
-
-
-
Budapest, 헝가리, 1122
- Országos Onkológiai Intézet
-
Budapest, 헝가리, 1204
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet
-
Budapest, 헝가리, 1145
- Uzsoki Utcai Korhaz
-
Budapest, 헝가리, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
-
-
-
-
New South Wales
-
Camperdown, New South Wales, 호주, 2050
- Chris O'Brien Lifehouse
-
Wollongong, New South Wales, 호주, 2500
- Cancer Care Wollongong Pty Limited
-
-
Queensland
-
Brisbane, Queensland, 호주, 4120
- Gallipoli Medical Research Foundation, Greenslopes Private Hospital
-
Southport, Queensland, 호주, 4215
- Gold Coast University Hospital
-
-
South Australia
-
Woodville South, South Australia, 호주, 5011
- The Queen Elizabeth Hospital
-
-
Victoria
-
East Melbourne, Victoria, 호주, 3002
- Epworth Freemasons-Epworth HealthCare
-
Malvern, Victoria, 호주, 3144
- Cabrini Hospital
-
Richmond, Victoria, 호주, 3121
- Epworth Foundation Trading as Epworth HealthCare
-
St Albans, Victoria, 호주, 3021
- Western Health, Sunshine Hospital
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).
-
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis.
-
Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx.
-
Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion 3.
-
Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a subset thereof, and to serve as a germline control in identifying tumor mutations.
-
Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study.
-
Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary.
-
Prior treatment of mCSPC with docetaxel is not permitted.
-
Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.
-
Other prior therapy allowed for mCSPC; ≤3 months of ADT (chemical or surgical) with or without approved NHT in mCSPC (ie, abiraterone + prednisone, apalutamide, or enzalutamide), if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
-
Participant may have received palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should have been completed at least 2 weeks prior to randomization. NOTE: Radical prostatectomy or definitive radiotherapy to the primary tumor for metastatic castration-sensitive prostate cancer with curative intent is not permitted.
-
ECOG performance status 0 or 1.
-
Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following:
- ANC ≥1500/µL, platelets ≥100,000/µL, or hemoglobin ≥9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology laboratory tests at screening).
- Total serum bilirubin <1.5 × ULN (<3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
- AST or ALT <2.5 × ULN (<5 × ULN if liver function abnormalities are due to hepatic metastasis).
- Albumin >2.8 g/dL.
- eGFR ≥30 mL/min/1.73 m2 by the MDRD equation.
-
Sexually active participants that in the opinion of the investigator are capable of ejaculating, must agree to use a condom when having sex with a partner (female or male) from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide). Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib / placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide) when having sex.
-
Must agree not to donate sperm from the first dose of study treatment to 4 months after the last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide).
-
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including being able to manage electronic diaries. The PRO assessments are not required to be completed if a patient does not understand the language(s) available for a specific questionnaire and/or cannot complete the specific questionnaire independently.
-
Capable of giving signed informed consent.
-
For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.
Exclusion Criteria:
-
Other acute or chronic medical (concurrent disease, infection, including chronic stable HIV, HBV, or HCV infection, or co-morbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant's ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator's judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority.
-
History of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient ischemic attack within 12 months of randomization.
-
Major surgery (as defined by the investigator) within 4 weeks before randomization.
-
Known or suspected brain metastasis or active leptomeningeal disease.
-
Symptomatic or impending spinal cord compression or cauda equina syndrome.
-
Any history of MDS, AML, or prior malignancy except for the following:
- Carcinoma in situ or non-melanoma skin cancer.
- A cancer diagnosed and treated ≥3 years before randomization with no subsequent evidence of recurrence.
- American Joint Committee on Cancer Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
-
In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
-
Clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or symptomatic cardiac ischemia within 6 months before randomization.
- Congestive heart failure New York Heart Association class III or IV.
- History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening.
- History of Mobitz II second degree or third-degree heart block unless a permanent pacemaker is in place.
- Hypotension as indicated by systolic blood pressure <86 mm Hg at screening.
- Bradycardia as indicated by a heart rate of <45 beats per minute on the screening electrocardiogram.
- Uncontrolled hypertension as indicated by systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening. However, participants can be rescreened after adequate control of blood pressure is achieved.
-
Active COVID-19 infection detected by viral test or based on clinical diagnosis (as assessed by investigator). Asymptomatic participants with no active COVID-19 infection detected but positive antibody tests, indicating past infection are allowed.
-
Prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months.
-
Participant received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to randomization, intended for the treatment of prostate cancer.
-
Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer.
-
Prior treatment with a PARPi, or known or possible hypersensitivity to enzalutamide, any of enzalutamide capsule excipients or to any talazoparib/placebo capsule excipients.
-
Prior treatment in any setting with NHT, except as described in Inclusion Criterion #10.
-
Current use of potent P-gp inhibitors within 7 days prior to randomization.
-
Treatment with any investigational study intervention within 4 weeks before randomization. Exception: COVID-19 vaccines authorized under an emergency use authorization (or equivalent) can be administered without a washout period.
-
Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >470 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >470 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
-
Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
-
For France only: Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, as well as adults subject to a legal protection measure (guardianship, curatorship, and safeguard of justice) covered by Articles 1121-6 to 1121-8 of the Public Health Code.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Arm 1
Talazoparib plus enzalutamide |
experimental arm
다른 이름들:
|
|
활성 비교기: Arm 2
Placebo plus enzalutamide |
Active comparator arm
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
radiological Progression-Free Survival
기간: randomization up to 3 years
|
time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first |
randomization up to 3 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival
기간: randomization up to 4 years
|
time from randomization to death from any cause |
randomization up to 4 years
|
|
Objective response in measurable soft tissue disease
기간: randomization up to 3 years
|
proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1 |
randomization up to 3 years
|
|
Duration of response in measurable soft tissue disease
기간: randomization up to 3 years
|
duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1 |
randomization up to 3 years
|
|
Prostate Specific Antigen (PSA) response
기간: randomization up to 3 years
|
proportion of patients with PSA response grater than or equal to 50% |
randomization up to 3 years
|
|
Time to PSA progression
기간: randomization up to 3 years
|
time from baseline to PSA progression |
randomization up to 3 years
|
|
Time to initiation of antineoplastic therapy
기간: randomization up to 3 years
|
Time from randomization to initiation of antineoplastic therapy |
randomization up to 3 years
|
|
Time to first symptomatic skeletal event
기간: randomization up to 3 years
|
time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first) |
randomization up to 3 years
|
|
Opiate use for prostate cancer pain
기간: randomization up to 3 years
|
time from randomization to opiate use for prostate cancer pain |
randomization up to 3 years
|
|
Incidence of adverse events
기간: randomization up to 3 years
|
AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03) |
randomization up to 3 years
|
|
Pharmacokinetic assessment of talazoparib
기간: Weeks 5, 9, 13, and 17
|
plasma concentrations of talazoparib |
Weeks 5, 9, 13, and 17
|
|
Pharmacokinetic assessment of enzalutamide and its metabolite
기간: Weeks 5, 9, 13, and 17
|
plasma concentrations of enzalutamide and its metabolite |
Weeks 5, 9, 13, and 17
|
|
Relationship between ctDNA burden and outcome
기간: randomization up to 3 years
|
ctDNA burden at baseline and on study |
randomization up to 3 years
|
|
Patient-reported outcomes in pain symptoms - change from baseline
기간: randomization up to 3 years
|
change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF) |
randomization up to 3 years
|
|
Patient-reported outcomes in pain symptoms - time to deterioration
기간: randomization up to 3 years
|
time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF) |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific general health status - change from baseline
기간: randomization up to 3 years
|
change from baseline in participant-reported general health status per EQ-5D-5L |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific global health status/QoL - change from baseline
기간: randomization up to 3 years
|
change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30 |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration
기간: randomization up to 3 years
|
time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30 |
randomization up to 3 years
|
|
Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
기간: randomization up to 3 years
|
time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25 |
randomization up to 3 years
|
|
Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline
기간: randomization up to 3 years
|
change from baseline in PGI-S |
randomization up to 3 years
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
일반 간행물
- Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. Future Oncol. 2024 Mar;20(9):493-505. doi: 10.2217/fon-2023-0526. Epub 2023 Oct 26.
- Agarwal N, Matsubara N, Azad AA, Saad F, Mateo J, Jiang S, Ye D, Voog E, Shore ND, Cil T, Vulsteke C, Chung HJ, Zschabitz S, Laird AD, Zhang X, Nandoskar P, Chetcuti SF, Wang F, Fizazi K. PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer. N Engl J Med. 2026 Jul 30;395(5):427-439. doi: 10.1056/NEJMoa2604126. Epub 2026 May 30.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- C3441052
- TALAPRO-3 (기타 식별자: Alias Study Number)
- 2024-510809-28-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .