DDR遺伝子変異mCSPCの男性におけるエンザルタミドとタラゾパリブの研究
TALAPRO-3: DDR 遺伝子変異転移性去勢感受性前立腺癌の男性における、エンザルタミドを含むタラゾパリブとエンザルタミドを含むプラセボの第 3 相無作為化二重盲検試験
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- University of Alabama at Birmingham
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Birmingham、Alabama、アメリカ、35249
- University of Alabama at Birmingham
-
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Arizona
-
Tucson、Arizona、アメリカ、85704
- Arizona Institute of Urology, PLLC
-
-
California
-
Beverly Hills、California、アメリカ、90211
- Beverly Hills Cancer Center
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Glendale、California、アメリカ、91206
- Adventist Health Glendale
-
Long Beach、California、アメリカ、90822
- VA Long Beach Healthcare System
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06510
- Yale-New Haven Hospital
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
-
Washington D.C.、District of Columbia、アメリカ、20010
- Washington Cancer Institute at MedStar Washington Hospital Center
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Florida
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Orlando、Florida、アメリカ、32804
- Investigational Drug Services, Advent Health Orlando
-
Orlando、Florida、アメリカ、32804
- AdventHealth Medical Group Hematology and Oncology
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Georgia
-
Austell、Georgia、アメリカ、30106
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Austell、Georgia、アメリカ、30106
- Wellstar Cobb Hospital
-
Carrollton、Georgia、アメリカ、30117
- Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
-
Carrollton、Georgia、アメリカ、30117
- West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
-
Cartersville、Georgia、アメリカ、30121
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Douglasville、Georgia、アメリカ、30134
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
-
Marietta、Georgia、アメリカ、30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
-
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Illinois
-
Lake Barrington、Illinois、アメリカ、60010
- Comprehensive Urologic Care, SC
-
Normal、Illinois、アメリカ、61761
- Mid-Illinois Hematology & Oncology Associates, Ltd
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Michigan
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Health System
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Medical Center - New Center One
-
Farmington Hills、Michigan、アメリカ、48334
- Revive Research Institute, Inc.
-
-
Missouri
-
St Louis、Missouri、アメリカ、63141
- David C. Pratt Cancer Center
-
-
New Jersey
-
Belleville、New Jersey、アメリカ、07109
- New Jersey Cancer Care, P.A.
-
-
New York
-
Poughkeepsie、New York、アメリカ、12603
- Premier Medical Group of the Hudson Valley PC
-
-
Oregon
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Portland、Oregon、アメリカ、97213
- Providence Cancer Institute Franz Clinic
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Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
-
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Pennsylvania
-
Lancaster、Pennsylvania、アメリカ、17604
- Keystone Urology Specialists
-
-
South Carolina
-
Myrtle Beach、South Carolina、アメリカ、29572
- Carolina Urologic Research Center, LLC
-
-
Tennessee
-
Bristol、Tennessee、アメリカ、37620
- Bristol Regional Medical Center
-
Kingsport、Tennessee、アメリカ、37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport、Tennessee、アメリカ、37660
- Indian Path Community Hospital
-
Kingsport、Tennessee、アメリカ、37660
- Holston Valley Hospital and Medical Center
-
-
Texas
-
Houston、Texas、アメリカ、77005
- Kelsey Research Foundation
-
Houston、Texas、アメリカ、77025
- Kelsey-Seybold Clinic
-
Houston、Texas、アメリカ、77027
- Houston Metro Urology
-
Houston、Texas、アメリカ、77008
- Oncology Consultants, P.A.
-
Houston、Texas、アメリカ、77030
- Oncology Consultants P.A.
-
Houston、Texas、アメリカ、77014
- Kelsey-Seybold Clinic
-
Houston、Texas、アメリカ、77055
- Kelsey-Seybold Clinic
-
Houston、Texas、アメリカ、77024
- oncology Consultants, P.A.
-
San Antonio、Texas、アメリカ、78229
- Urology San Antonio
-
Webster、Texas、アメリカ、77598
- Texas Oncology-Deke Slayton Cancer Center
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute - University of Utah
-
-
-
-
-
CABA、アルゼンチン、C1426ANZ
- Instituto Médico Especializado Alexander Fleming
-
Caba、アルゼンチン、C1426AGE
- Centro Oncologico Korben
-
Córdoba、アルゼンチン、X5008HHW
- Centro Medico Privado CEMAIC
-
-
Buenos Aires
-
Berazategui、Buenos Aires、アルゼンチン、B1884BBF
- COIBA
-
Pergamino、Buenos Aires、アルゼンチン、B2700CPM
- Centro de Investigacion Pergamino SA - Clinica Pergamino SA
-
-
Río Negro Province
-
Viedma、Río Negro Province、アルゼンチン、R8500ACE
- Centro de Investigaciones Clínicas - Clínica Viedma
-
-
Tucumán Province
-
San Miguel de Tucumán、Tucumán Province、アルゼンチン、T4000IAK
- Centro Medico San Roque
-
-
-
-
-
Birmingham、イギリス、B9 5SS
- University Hospitals Birmingham NHS Foundation Trust
-
Glasgow、イギリス、G12 0YN
- NHS Greater Glasgow and Clyde
-
London、イギリス、SW3 6JJ
- The Royal Marsden NHS Foundation Trust
-
London、イギリス、W6 8RF
- Imperial College Healthcare NHS Trust
-
Manchester、イギリス、M20 4BX
- The Christie NHS Foundation Trust
-
-
Devon
-
Exeter、Devon、イギリス、EX2 5DW
- Royal Devon and Exeter NHS Foundation Trust
-
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KENT
-
Maidstone、KENT、イギリス、ME16 9QQ
- Maidstone and Tunbridge Wells NHS Trust
-
-
Lancashire
-
Preston、Lancashire、イギリス、PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust
-
-
Midlothian
-
Edinburgh、Midlothian、イギリス、EH4 2XU
- NHS Lothian
-
-
Scotland
-
Glasgow、Scotland、イギリス、G12 0XH
- Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital
-
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South Yorkshire
-
Sheffield、South Yorkshire、イギリス、S10 2SJ
- Sheffield Teaching Hospitals NHS Foundation Trust
-
-
-
-
-
Arezzo、イタリア、52100
- Ospedale San Donato
-
Arezzo、イタリア、52100
- Azienda Unita Sanitaria Locale Toscana Sud-Est
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Bari、イタリア、70124
- IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
-
Bergamo、イタリア、24127
- ASST Papa Giovanni XXIII
-
Brescia、イタリア、25123
- ASST degli Spedali Civili de Brescia
-
Orbassano、イタリア、10043
- Azienda Ospedaliera Universitaria San Luigi Gonzaga- Uinta di Oncologia Polmonare
-
Verona、イタリア、37134
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
BO
-
Bologna、BO、イタリア、40138
- Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
-
-
CR
-
Cremona、CR、イタリア、26100
- ASST Cremona
-
-
FC
-
Meldola、FC、イタリア、47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
-
-
FG
-
San Giovanni Rotondo、FG、イタリア、71013
- Fondazione Casa Sollievo della Sofferenza
-
-
Naples
-
Naples、Naples、イタリア、80131
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
-
-
PN
-
Aviano、PN、イタリア、33081
- Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
-
-
TN
-
Trento、TN、イタリア、38122
- Ospedale Santa Chiara
-
-
Trentino-Alto Adige
-
Trento、Trentino-Alto Adige、イタリア、38123
- Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento
-
-
-
-
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New Delhi、インド、600028
- Indraprastha Apollo Hospitals
-
-
Gujarat
-
Surat、Gujarat、インド、395009
- Gujarat Hospital - Gastro and Vascular Centre
-
-
Haryana
-
Gurugram、Haryana、インド、122001
- Medanta- The Medicity hospital
-
Gurugram、Haryana、インド、122001
- Artemis hospital
-
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Maharashtra
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Mumbai、Maharashtra、インド、401107
- Bhaktivedanta Hospital and Research Institute
-
Pune、Maharashtra、インド、411004
- Sahyadri Super Speciality Hospital
-
Pune、Maharashtra、インド、411004
- Sahyadri Clinical Research & Development Centre
-
Pune、Maharashtra、インド、411038
- Sahyadri Hospitals Private Limited
-
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National Capital Territory of Delhi
-
New Delhi、National Capital Territory of Delhi、インド、110076
- Indraprastha Apollo Hospital
-
New Delhi、National Capital Territory of Delhi、インド、110085
- Rajiv Gandhi Cancer Institute and Research Centre
-
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Uttar Pradesh
-
Meerut、Uttar Pradesh、インド、250001
- Valentis Cancer Hospital
-
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West Bengal
-
Kolkata、West Bengal、インド、700094
- Netaji Subhas Chandra Bose Cancer Hospital
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-
-
-
-
Dnipro、ウクライナ、49102
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
-
Dnipro、ウクライナ、49005
- Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
-
Kharkiv、ウクライナ、61070
- Communal Non-Profit Enterprise "Regional Center of Oncology"
-
Kharkiv、ウクライナ、61037
- Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
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Lviv、ウクライナ、79031
- Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
-
-
Dnipropetrovsk Oblast
-
Kryviy Rih、Dnipropetrovsk Oblast、ウクライナ、50048
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
-
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Kyiv Oblast
-
Pliuty Village、Kyiv Oblast、ウクライナ、08720
- Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
-
-
Kyivska Oblast
-
Khodosovka、Kyivska Oblast、ウクライナ、08173
- Asklepion Medical Center
-
Kyiv、Kyivska Oblast、ウクライナ、03022
- National Cancer Institute
-
-
-
-
-
The Hague、オランダ、2545 AA
- Stichting HagaZiekenhuis
-
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Utrecht
-
Amersfoort、Utrecht、オランダ、3813 TZ
- Meander Medisch Centrum
-
-
-
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New South Wales
-
Camperdown、New South Wales、オーストラリア、2050
- Chris O'Brien Lifehouse
-
Wollongong、New South Wales、オーストラリア、2500
- Cancer Care Wollongong Pty Limited
-
-
Queensland
-
Brisbane、Queensland、オーストラリア、4120
- Gallipoli Medical Research Foundation, Greenslopes Private Hospital
-
Southport、Queensland、オーストラリア、4215
- Gold Coast University Hospital
-
-
South Australia
-
Woodville South、South Australia、オーストラリア、5011
- The Queen Elizabeth Hospital
-
-
Victoria
-
East Melbourne、Victoria、オーストラリア、3002
- Epworth Freemasons-Epworth HealthCare
-
Malvern、Victoria、オーストラリア、3144
- Cabrini Hospital
-
Richmond、Victoria、オーストラリア、3121
- Epworth Foundation Trading as Epworth HealthCare
-
St Albans、Victoria、オーストラリア、3021
- Western Health, Sunshine Hospital
-
-
-
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Alberta
-
Calgary、Alberta、カナダ、T2V 1P9
- Prostate Cancer Centre
-
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Nova Scotia
-
Halifax、Nova Scotia、カナダ、B3H 2Y9
- Centre of Applied Urology Research, Nova Scotia Health Authority
-
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Ontario
-
London、Ontario、カナダ、N6A 5W9
- London Health Sciences Centre
-
London、Ontario、カナダ、N6C2R5
- Organisation Lawson Health Research Institute
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Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital Cancer Center
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Toronto、Ontario、カナダ、M5G 2M9
- University Health Network-Princess Margaret Cancer Centre
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Quebec
-
Chicoutimi、Quebec、カナダ、G7H 5H6
- CIUSSS- saguenay-Lac-Saint-Jean
-
Chicoutimi、Quebec、カナダ、G7H 7K9
- Centre integre universitaire de sante et de services sociaux Saguenay-Lac-Saint-Jean
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Greenfield Park、Quebec、カナダ、J4V 2H3
- Urology South Shore Research
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Montreal、Quebec、カナダ、H3T 1E2
- Jewish General Hospital
-
Montreal、Quebec、カナダ、H4A 3J1
- McGill University Health Center
-
Montreal、Quebec、カナダ、H2X 0A9
- Centre Hospitalier de I'Universite de Montreal (CHUM)
-
Montreal、Quebec、カナダ、H2X 0A9
- CHUM - Centre Hospitalier de l'Université de Montréal
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-
-
-
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Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron
-
Barcelona、スペイン、08036
- Hospital Clínic de Barcelona
-
Córdoba、スペイン、14004
- Hospital Universitario Reina Sofía
-
Madrid、スペイン、28040
- Hospital Clinico San Carlos
-
Madrid、スペイン、28033
- MD Anderson Cancer Center
-
Madrid、スペイン、28009
- Hospital Universitario Gregorio Marañón
-
Seville、スペイン、41009
- Hospital Universitario Virgen de la Macarena
-
Valencia、スペイン、46026
- Hospital Politecnic Universitari La Fe
-
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Alicante
-
Elche、Alicante、スペイン、03203
- Hospital General Universitario de Elche
-
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Barcelona
-
L'Hospitalet de Llobregat、Barcelona、スペイン、08908
- Institut Català d'Oncologia de l'Hospitalet
-
Manresa、Barcelona、スペイン、08243
- Althaia, Xarxa Assistencial Universitària de Manresa
-
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Barcelona [barcelona]
-
Badalona、Barcelona [barcelona]、スペイン、08916
- Hospital Germans Trias i Pujol
-
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Galicia
-
Lugo、Galicia、スペイン、27003
- Hospital Universitario Lucus Augusti
-
-
Madrid, Comunidad de
-
Majadahonda、Madrid, Comunidad de、スペイン、28222
- Hospital Universitario Puerta de Hierro
-
-
Navarre
-
Pamplona、Navarre、スペイン、31008
- Complejo Hospitalario de Navarra
-
-
Principality of Asturias
-
Oviedo、Principality of Asturias、スペイン、33011
- Hospital Universitario Central de Asturias
-
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Tarragona
-
Reus、Tarragona、スペイン、43204
- Hospital Universitari Sant Joan de Reus
-
-
Valenciana, Comunitat
-
Valencia、Valenciana, Comunitat、スペイン、46009
- Fundación Instituto Valenciano de Oncología
-
-
-
-
-
Banská Bystrica、スロバキア、975 17
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
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Bratislava、スロバキア、833 10
- Narodny onkologicky ustav
-
Košice、スロバキア、041 91
- Vychodoslovensky onkologicky ustav, a.s.
-
Nitra、スロバキア、949 01
- UROEXAM, spol. s r.o.
-
Poprad、スロバキア、058 01
- POKO Poprad s.r.o.
-
Prešov、スロバキア、08001
- MILAB s.r.o.
-
Trenčín、スロバキア、911 01
- Privatna urologicka ambulancia, s.r.o.
-
-
-
-
-
Olomouc、チェコ、779 00
- Fakultni nemocnice Olomouc
-
Ostrava - Poruba、チェコ、708 52
- Fakultni nemocnice Ostrava
-
Prague、チェコ、100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Prague、チェコ、150 00
- Fakultni Nemocnice Motol a Homolka
-
Praha 8- Liben、チェコ、180 81
- Fakultni nemocnice Bulovka
-
-
-
-
-
Adana、トルコ（Türkiye）、01415
- Adana City Training and Research Hospital
-
Ankara、トルコ（Türkiye）、06620
- Ankara University Faculty of Medicine
-
Ankara、トルコ（Türkiye）、06800
- Ankara City Hospital
-
Edirne、トルコ（Türkiye）、22030
- Trakya University Medical Faculty
-
Istanbul、トルコ（Türkiye）、34098
- Istanbul University, Cerrahpasa Faculty of Medicine
-
Istanbul、トルコ（Türkiye）、34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Malatya、トルコ（Türkiye）、44280
- Inonu University, Faculty of Medicine
-
-
-
-
-
Berlin、ドイツ、10117
- Charite Universitaetsmedizin Berlin - Campus Mitte
-
Duisburg、ドイツ、47169
- Urologicum Duisburg
-
Frankfurt、ドイツ、60590
- Universitaetsklinikum Frankfurt
-
Göttingen、ドイツ、37075
- Institut fuer Diagnostische und Interventionelle Radiologie
-
Göttingen、ドイツ、37075
- Klinik fuer Nuklearmedizin
-
Heidelberg、ドイツ、69120
- Universitaetsklinik Heidelberg
-
Leipzig、ドイツ、04105
- Uro-/Onkologisches Zentrum
-
Nürtingen、ドイツ、72622
- Studienpraxis Urologie
-
Tübingen、ドイツ、72076
- Universitaetsklinikum Tuebingen
-
-
Lower Saxony
-
Göttingen、Lower Saxony、ドイツ、37075
- Universitaetsmedizin Goettingen
-
-
North Rhine-Westphalia
-
Wesel、North Rhine-Westphalia、ドイツ、46483
- Urologische Gemeinschaftspraxis Wesel
-
-
Thuringia
-
Jena、Thuringia、ドイツ、07747
- Universitätsklinikum Jena
-
-
-
-
-
Gjøvik、ノルウェー、2819
- Sykehuset Innlandet Gjoevik
-
-
-
-
-
Budapest、ハンガリー、1122
- Országos Onkológiai Intézet
-
Budapest、ハンガリー、1204
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet
-
Budapest、ハンガリー、1145
- Uzsoki Utcai Korhaz
-
Budapest、ハンガリー、1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
-
-
-
-
-
Helsinki、フィンランド、00029
- Helsinki University Hospital
-
Helsinki、フィンランド、00180
- Docrates Cancer Center
-
Helsinki、フィンランド、00280
- Clinical Research Institute Helsinki University Central Hospital Ltd
-
Kuopio、フィンランド、70210
- Kuopio University Hospital
-
Tampere、フィンランド、33520
- Tampere University Hospital
-
Turku、フィンランド、20520
- Turku University Hospital
-
-
-
-
-
Angers、フランス、49933
- Centre Hospitalier Universitaire d'Angers
-
Bayonne、フランス、64100
- Clinique Belharra
-
Lille、フランス、59000
- Hopital Prive le Bois
-
Lyon、フランス、69373
- Centre Leon Berard
-
Paris、フランス、75018
- Hopital Bichat - Claude Bernard
-
Paris、フランス、75877
- Hopital Bichat - Claude Bernard
-
Pierre-Bénite、フランス、69310
- Hopital Lyon Sud
-
Quint-Fonsegrives、フランス、31130
- Clinique La Croix du Sud - Ramsay Sante
-
Reims、フランス、51726
- Institut Jean Godinot
-
Saint-Grégoire、フランス、35760
- CHP Saint-Grégoire
-
Strasbourg、フランス、67200
- Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
-
Vandœuvre-lès-Nancy、フランス、54519
- Institut de cancerologie de Lorraine
-
Villejuif、フランス、94805
- Gustave Roussy
-
-
Brittany Region
-
Brest、Brittany Region、フランス、29200
- CHU Morvan de Brest
-
-
Pays de la Loire Region
-
Le Mans、Pays de la Loire Region、フランス、72000
- Clinique Victor Hugo Le Mans
-
-
Île-de-France Region
-
Créteil、Île-de-France Region、フランス、94010
- Hopital Henri Mondor
-
-
-
-
-
Panagyurishte、ブルガリア、4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD
-
Plovdiv、ブルガリア、4000
- Complex Oncology Center - Plovdiv EOOD
-
Plovdiv、ブルガリア、4000
- Independent medical-diagnostic laboratory "Medisken" EOOD
-
Plovdiv、ブルガリア、4000
- Complex Oncology Center- Plovdiv EOOD
-
Shumen、ブルガリア、9700
- Complex Oncology Center - Shumen EOOD
-
Sofia、ブルガリア、1407
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
-
Sofia、ブルガリア
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
-
Stara Zagora、ブルガリア、6003
- Complex Oncology Center - Stara Zagora Ltd.
-
Stara Zagora、ブルガリア、6003
- MRI SMDLOD "Mediscan" Ltd
-
Stara Zagora、ブルガリア、6003
- UMHAT "Prof. Dr. Stoyan Kirkovich"
-
-
-
-
-
Aalst、ベルギー、9300
- Onze Lieve Vrouw Ziekenhuis Aalst
-
Anderlecht、ベルギー、1070
- Institut Jules Bordet
-
Brussels、ベルギー、1200
- Cliniques universitaires Saint-Luc
-
Brussels、ベルギー、1000
- Institut Jules Bordet
-
Ghent、ベルギー、9000
- AZ (Algemeen Ziekenhuis) Maria Middelares
-
Ghent、ベルギー、9000
- AZ (Algemeen Ziekenhuis) Sint-Lucas
-
Kortrijk、ベルギー、8500
- AZ (Algemeen Ziekenhuis) Groeninge
-
Liège、ベルギー、4000
- CHU de Liege
-
Merksem、ベルギー、2170
- ZNA Jan Palfijn
-
-
-
-
-
Oaxaca City、メキシコ、68020
- Centro de Investigacion Clinica de Oaxaca
-
Veracruz、メキシコ、91851
- Instituto Veracruzano en Investigación Clínica S.C.
-
-
Guanajuato
-
León、Guanajuato、メキシコ、37178
- Preparaciones Oncológicas S.C.
-
-
Nuevo León
-
Monterrey、Nuevo León、メキシコ、64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
-
Monterrey、Nuevo León、メキシコ、64040
- Axis Heilsa S. de R.L. de C.V.
-
-
Oaxaca
-
Oaxaca City、Oaxaca、メキシコ、68000
- Oaxaca Site Management Organization
-
-
State of Mexico
-
Naucalpan、State of Mexico、メキシコ、53100
- Oncologia Integral Satelite SA de CV
-
-
-
-
-
Chelyabinsk、ロシア、454048
- Evimed Llc
-
Chelyabinsk、ロシア、454087
- SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
-
Ivanovo、ロシア、153040
- Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
-
Moscow、ロシア、117997
- Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
-
Moscow、ロシア、121205
- Branch of the Limited Liability Company "Hadassah Medical Ltd."
-
Moscow、ロシア、121359
- Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
-
Omsk、ロシア、644013
- BHI of Omsk region "Clinical Oncological Dispensary"
-
Saint Petersburg、ロシア、191025
- LLC "Medicina Severnoy Stolitsy"
-
Saint Petersburg、ロシア、192007
- LLC "Severo-Zapadny Medical Center"
-
Samara、ロシア、443011
- Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
-
Ufa、ロシア、450054
- SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
-
Vologda、ロシア、160002
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
-
Vologda、ロシア、160022
- Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
-
Yaroslavl、ロシア、150054
- State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
-
-
Kaluga Oblast
-
Obninsk、Kaluga Oblast、ロシア、249036
- MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
-
-
Sankt-Peterburg
-
Pushkin、Sankt-Peterburg、ロシア、196603
- Private Medical Institution "Euromedservice"
-
-
Stavropol Kray
-
Pyatigorsk、Stavropol Kray、ロシア、357502
- Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
-
-
-
-
-
Chongqing、中国、400042
- The First Affiliated Hospital Chongqing Medical University
-
Guangzhou、中国、510120
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Anhui
-
Hefei、Anhui、中国、230022
- The First Affiliated Hospital of Anhui Medical University
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100034
- Peking University First Hospital
-
-
Gansu
-
Lanzhou、Gansu、中国、730030
- Lanzhou university second hospital
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510515
- Nanfang Hospital of Southern Medical University
-
Guangzhou、Guangdong、中国、510230
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Henan
-
Zhengzhou、Henan、中国、450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- Hubei Cancer Hospital
-
Wuhan、Hubei、中国、430022
- Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
-
Wuhan、Hubei、中国、430030
- Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
-
-
Hunan
-
Changsha、Hunan、中国、410013
- Hunan Cancer Hospital
-
Changsha、Hunan、中国、410013
- The Third Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210009
- Zhongda Hospital Southeast University
-
Nantong、Jiangsu、中国、226000
- Nantong Tumor Hospital
-
Suzhou、Jiangsu、中国、215004
- The Second Affiliated Hospital of Soochow University
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330029
- Jiangxi Provincial Cancer Hospital
-
-
Jilin
-
Changchun、Jilin、中国、130021
- The First hospital of Jilin University
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200032
- Fudan University Cancer Hospital
-
-
Sichuan
-
Chengdu、Sichuan、中国、610041
- West China Hospital of Sichuan University
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300211
- The Second Hospital of Tianjin Medical University
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310014
- Zhejiang Provincial People's Hospital
-
Ningbo、Zhejiang、中国、315010
- The first affiliated hospital of Ningbo university
-
Wenzhou、Zhejiang、中国、325000
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
Gauteng
-
Johannesburg、Gauteng、南アフリカ、2193
- Charlotte Maxeke Johannesburg Academic Hospital
-
Johannesburg、Gauteng、南アフリカ、2193
- 15 Eton Road
-
Johannesburg、Gauteng、南アフリカ、2193
- WCR Office
-
Johannesburg、Gauteng、南アフリカ、2196
- Sandton Oncology Medical Group (Pty) Ltd
-
Parktown、Gauteng、南アフリカ、2193
- Wits Clinical Research
-
Pretoria、Gauteng、南アフリカ、0002
- Clinical Research Unit, University of Pretoria
-
-
-
-
-
Kaohsiung City、台湾、807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung、台湾、40705
- Taichung Veterans General Hospital
-
Tainan、台湾、704
- National Cheng Kung University Hospital
-
Taipei、台湾、10002
- National Taiwan University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taoyuan City、台湾、333
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Kagoshima、日本、890-8520
- Kagoshima University Hospital
-
Kumamoto、日本、860-0008
- National Hospital Organization Kumamoto Medical Center
-
Tokushima、日本、770-8503
- Tokushima University Hospital
-
Yamagata、日本、990-9585
- Yamagata University Hospital
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、466-8560
- Nagoya University Hospital
-
-
Aomori
-
Hirosaki、Aomori、日本、036-8563
- Hirosaki University School of Medicine & Hospital
-
-
Chiba
-
Chiba、Chiba、日本、2608717
- Chiba cancer center
-
Kashiwa、Chiba、日本、277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama、Ehime、日本、791-0280
- National Hospital Organization Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本、811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Hiroshima
-
Kure、Hiroshima、日本、737-0023
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center
-
-
Hokkaido
-
Sapporo、Hokkaido、日本、003-0804
- National Hospital Organization Hokkaido Cancer Center
-
Sapporo、Hokkaido、日本、060-8648
- Hokkaido University Hospital
-
-
Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8641
- Kanazawa University Hospital
-
-
Kanagawa
-
Yokohama、Kanagawa、日本、232-0024
- Yokohama City University Medical Center
-
Yokosuka、Kanagawa、日本、238-8558
- Yokosukakyosai
-
-
Osaka
-
Osaka、Osaka、日本、5418567
- Osaka International Cancer Institute
-
Sakai、Osaka、日本、590-0197
- Kindai University Hospital
-
Suita、Osaka、日本、565-0871
- The University of Osaka Hospital
-
-
Shizuoka
-
Hamamatsu、Shizuoka、日本、431-3192
- Hamamatsu University Hospital
-
-
Tokyo
-
Meguro-Ku、Tokyo、日本、152-8902
- National Hospital Organization Tokyo Medical Center
-
Shinjuku-ku、Tokyo、日本、160-8582
- Keio university hospital
-
-
-
-
-
Daegu、韓国、41404
- Kyungpook National University Chilgok Hospital
-
Seoul、韓国、03080
- Seoul National University Hospital
-
Seoul、韓国、05505
- Asan Medical Center
-
Seoul、韓国、06351
- Samsung Medical Center
-
Seoul、韓国、03722
- Severance Hospital, Yonsei University Health System
-
Seoul、韓国、06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
-
Seoul、韓国、06273
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul、韓国、07985
- Ewha Womans University Mokdong Hospital
-
-
Gyeonggi-do
-
Goyang-si、Gyeonggi-do、韓国、10408
- National Cancer Center
-
-
Jeollanam-do
-
Hwasun-gun、Jeollanam-do、韓国、58128
- Chonnam National University Hwasun Hospital
-
-
Kyǒnggi-do
-
Seongnam、Kyǒnggi-do、韓国、13620
- Seoul National University Bundang Hospital
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Arm 1
Talazoparib plus enzalutamide |
experimental arm
他の名前：
|
|
アクティブコンパレータ：Arm 2
Placebo plus enzalutamide |
Active comparator arm
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
radiological Progression-Free Survival
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：randomization up to 3 years
|
time from baseline to PSA progression |
randomization up to 3 years
|
|
Time to initiation of antineoplastic therapy
時間枠：randomization up to 3 years
|
Time from randomization to initiation of antineoplastic therapy |
randomization up to 3 years
|
|
Time to first symptomatic skeletal event
時間枠：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
時間枠：randomization up to 3 years
|
time from randomization to opiate use for prostate cancer pain |
randomization up to 3 years
|
|
Incidence of adverse events
時間枠：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
時間枠：Weeks 5, 9, 13, and 17
|
plasma concentrations of talazoparib |
Weeks 5, 9, 13, and 17
|
|
Pharmacokinetic assessment of enzalutamide and its metabolite
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：randomization up to 3 years
|
change from baseline in PGI-S |
randomization up to 3 years
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- C3441052
- TALAPRO-3 (その他の識別子：Alias Study Number)
- 2024-510809-28-00 (レジストリ識別子：CTIS (EU))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。