Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

599

Participants

Timeline

Start Date

May 12, 2021

Primary Completion Date

February 18, 2026

Study Completion Date

August 28, 2027

Conditions
Prostate Cancer
Interventions
DRUG

talazoparib plus enzalutamide

experimental arm

DRUG

Placebo plus enzalutamide

Active comparator arm

Trial Locations (298)

333

Linkou Chang Gung Memorial Hospital, Taoyuan

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1070

Institut Jules Bordet, Anderlecht

1076

Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet, Budapest

1122

Országos Onkológiai Intézet, Budapest

1145

Uzsoki Utcai Korhaz, Budapest

1200

Cliniques universitaires Saint-Luc, Brussels

1204

Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Budapest

1407

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia

2050

Chris O'Brien Lifehouse, Camperdown

2170

ZNA Jan Palfijn, Merksem

2193

15 Eton Road, Johannesburg

Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg

WCR Office, Johannesburg

Wits Clinical Research, Parktown

2196

Sandton Oncology Medical Group (Pty) Ltd, Johannesburg

2500

Cancer Care Wollongong Pty Limited, Wollongong

2819

Sykehuset Innlandet Gjoevik, Gjøvik

3002

Epworth Freemasons-Epworth HealthCare, East Melbourne

3021

Western Health, Sunshine Hospital, St Albans

3144

Cabrini Hospital, Malvern

4000

CHU de Liege, Liège

Complex Oncology Center - Plovdiv EOOD, Plovdiv

"Independent medical-diagnostic laboratory Medisken EOOD", Plovdiv

4120

Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Brisbane

4215

Gold Coast University Hospital, Southport

4500

Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagyurishte

5011

The Queen Elizabeth Hospital, Woodville South

6003

Complex Oncology Center - Stara Zagora Ltd., Stara Zagora

"MRI SMDLOD Mediscan Ltd", Stara Zagora

"UMHAT Prof. Dr. Stoyan Kirkovich", Stara Zagora

8500

AZ (Algemeen Ziekenhuis) Groeninge, Kortrijk

9000

AZ (Algemeen Ziekenhuis) Maria Middelares, Ghent

AZ (Algemeen Ziekenhuis) Sint-Lucas, Ghent

9300

Onze Lieve Vrouw Ziekenhuis Aalst, Aalst

9700

Complex Oncology Center - Shumen EOOD, Shumen

10002

National Taiwan University Hospital, Taipei

10043

AOU San Luigi Gonzaga, Orbassano

10117

Charite Universitaetsmedizin Berlin - Campus Mitte, Berlin

10408

National Cancer Center, Goyang-si

11217

Taipei Veterans General Hospital, Taipei

12603

Premier Medical Group of the Hudson Valley PC, Poughkeepsie

13620

Seoul National University Bundang Hospital, Seongnam

14004

Hospital Universitario Reina Sofía, Córdoba

17604

Keystone Urology Specialists, Lancaster

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

Washington Cancer Institute at MedStar Washington Hospital Center, Washington D.C.

20520

Turku University Hospital, Turku

22030

Trakya University Medical Faculty, Edirne

24127

ASST Papa Giovanni XXIII, Bergamo

25123

ASST degli Spedali Civili de Brescia, Brescia

26100

ASST Cremona, Cremona

27003

Hospital Universitario Lucus Augusti, Lugo

28009

Hospital Universitario Gregorio Marañón, Madrid

28033

MD Anderson Cancer Center, Madrid

28040

Hospital Clinico San Carlos, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29200

CHU Morvan de Brest, Brest

CHU Morvan de Brest, Brest

29572

Carolina Urologic Research Center, LLC, Myrtle Beach

Parkway Surgery Center, Myrtle Beach

30060

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta

30106

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Austell

Wellstar Cobb Hospital, Austell

30117

Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica, Carrollton

West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica, Carrollton

30121

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Cartersville

30134

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Douglasville

31008

Complejo Hospitalario de Navarra, Pamplona

31130

Clinique La Croix du Sud - Ramsay Sante, Quint-Fonsegrives

32804

AdventHealth Medical Group Hematology and Oncology, Orlando

Investigational Drug Services, Advent Health Orlando, Orlando

33011

Hospital Universitario Central de Asturias, Oviedo

33081

Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano

33520

Tampere University Hospital, Tampere

34098

Istanbul University, Cerrahpasa Faculty of Medicine, Istanbul

34722

Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul

35233

University of Alabama at Birmingham, Birmingham

35249

University of Alabama at Birmingham, Birmingham

35760

CHP Saint-Grégoire, Saint-Grégoire

37075

Universitaetsmedizin Goettingen, Göttingen

Institut fuer Diagnostische und Interventionelle Radiologie, Göttingen

37134

Azienda Ospedaliera Universitaria Integrata Verona, Verona

37178

Preparaciones Oncológicas S.C., León

37620

Bristol Regional Medical Center, Bristol

37660

Ballad Health Cancer Care - Kingsport, Kingsport

Holston Valley Hospital and Medical Center, Kingsport

Indian Path Community Hospital, Kingsport

38122

Ospedale Santa Chiara, Trento

40138

Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi, Bologna

41009

Hospital Universitario Virgen de la Macarena, Seville

41404

Kyungpook National University Chilgok Hospital, Daegu

43204

Hospital Universitari Sant Joan de Reus, Reus

44280

Inonu University, Faculty of Medicine, Malatya

46009

Fundación Instituto Valenciano de Oncología, Valencia

46026

Hospital Politecnic Universitari La Fe, Valencia

46483

Urologische Gemeinschaftspraxis Wesel, Wesel

47014

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori (IRST)", Meldola

47169

Urologicum Duisburg, Duisburg

48202

Henry Ford Health System, Detroit

Henry Ford Medical Center - New Center One, Detroit

48334

Revive Research Institute, Inc., Farmington Hills

49005

"Municipal Ent Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)", Dnipro

49102

"Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council", Dnipro

49933

Centre Hospitalier Universitaire d'Angers, Angers

50048

MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department, Kryviy Rih

51726

Institut Jean Godinot, Reims

52100

Ospedale San Donato, Arezzo

53100

Oncologia Integral Satelite SA de CV, Naucalpan

54519

Institut de cancerologie de Lorraine, Vandœuvre-lès-Nancy

58128

Chonnam National University Hwasun Hospital, Hwasun-gun

59000

Hopital Prive le Bois, Lille

60010

Comprehensive Urologic Care, SC, Lake Barrington

60590

Universitaetsklinikum Frankfurt, Frankfurt

61037

Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of, Kharkiv

61070

"Communal Non-Profit Enterprise Regional Center of Oncology", Kharkiv

61761

Mid-Illinois Hematology & Oncology Associates, Ltd, Normal

63141

David C. Pratt Cancer Center, St Louis

64040

Axis Heilsa S. de R.L. de C.V., Monterrey

64100

Clinique Belharra, Bayonne

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey

67200

Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe), Strasbourg

68000

Oaxaca Site Management Organization, Oaxaca City

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

69120

Universitaetsklinik Heidelberg, Heidelberg

69310

Hopital Lyon Sud, Pierre-Bénite

69373

Centre Leon Berard, Lyon

70124

"IRCCS Istituto Tumori Giovanni Paolo II di Bari", Bari

70210

Kuopio University Hospital, Kuopio

71013

Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo

72000

Clinique Victor Hugo Le Mans, Le Mans

72076

Universitaetsklinikum Tuebingen, Tübingen

72622

Studienpraxis Urologie, Nürtingen

75018

Hopital Bichat - Claude Bernard, Paris

75877

Hopital Bichat - Claude Bernard, Paris

77005

Kelsey Research Foundation, Houston

77008

Oncology Consultants, P.A., Houston

77014

Kelsey-Seybold Clinic, Houston

77024

oncology Consultants, P.A., Houston

77025

Kelsey-Seybold Clinic, Houston

77027

Houston Metro Urology, Houston

77030

Oncology Consultants P.A., Houston

77055

Kelsey-Seybold Clinic, Houston

77598

Texas Oncology-Deke Slayton Cancer Center, Webster

78229

Urology San Antonio, San Antonio

79031

"Comm Noncommerc Entp Lviv Reg Council Lviv Oncological Regional Therapeutical and Diagnostic Cntre", Lviv

80131

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli, Napoli

84112

Huntsman Cancer Institute - University of Utah, Salt Lake City

85704

Arizona Institute of Urology, PLLC, Tucson

90211

Beverly Hills Cancer Center, Beverly Hills

90822

VA Long Beach Healthcare System, Long Beach

91206

Adventist Health Glendale, Glendale

91851

Instituto Veracruzano en Investigación Clínica S.C., Veracruz

94010

Hopital Henri Mondor, Créteil

94805

Gustave Roussy, Villejuif

97213

Providence Cancer Institute Franz Clinic, Portland

100034

Peking University First Hospital, Beijing

110076

Indraprastha Apollo Hospital, New Delhi

110085

Rajiv Gandhi Cancer Institute and Research Centre, New Delhi

117997

"Federal State Budgetary Institution Russian Research Center of Roentgenology and Radiology of the", Moscow

121205

"Branch of the Limited Liability Company Hadassah Medical Ltd.", Moscow

121359

"Federal State Budgetary Institution Central Clinical Hospital with ambulance", Moscow

122001

Artemis hospital, Gurugram

Medanta- The Medicity hospital, Gurugram

130021

The First hospital of Jilin University, Changchun

150054

"State Budgetary Institution of Healthcare of Yaroslavl Region Regional Clinical Oncology Hospital", Yaroslavl

153040

"Regional Budgetary Healthcare Institution Ivanovskiy Regional Oncology Dispensary (RBHI IvROD)", Ivanovo

160002

"Budgetary Healthcare Institution of Vologda region Vologda Regional Clinical Hospital", Vologda

160022

"Budgetary Healthcare Institution of Vologda region Vologda Regional Clinical Hospital", Vologda

191025

"LLC Medicina Severnoy Stolitsy", Saint Petersburg

192007

"LLC Severo-Zapadny Medical Center", Saint Petersburg

196603

"Private Medical Institution Euromedservice", Pushkin

200032

Fudan University Cancer Hospital, Shanghai

210009

Zhongda Hospital Southeast University, Nanjing

215004

The Second Affiliated Hospital of Soochow University, Suzhou

226000

Nantong Tumor Hospital, Nantong

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

249036

"MRRC n.a. A.F. Tsyb - branch of FSBI NMRC of Radiology Minzdrav Russia", Obninsk

250001

Valentis Cancer Hospital, Meerut

300211

The Second Hospital of Tianjin Medical University, Tianjin

310014

Zhejiang Provincial People's Hospital, Hangzhou

315010

The first affiliated hospital of Ningbo university, Ningbo

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

330029

Jiangxi Provincial Cancer Hospital, Nanchang

357502

"Limited Liability Company 4D Ultrasound Clinic (LLC 4D Ultrasound Clinic)", Pyatigorsk

395009

Gujarat Hospital - Gastro and Vascular Centre, Surat

400042

The First Affiliated Hospital Chongqing Medical University, Chongqing

401107

Bhaktivedanta Hospital and Research Institute, Mumbai

410013

Hunan Cancer Hospital, Changsha

The Third Xiangya Hospital of Central South University, Changsha

411004

Sahyadri Clinical Research & Development Centre, Pune

Sahyadri Super Speciality Hospital, Pune

430022

Union Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan

430030

Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

443011

"Private Institution Educational Organization of Higher Education Medical University REAVIZ", Samara

450008

Henan Cancer Hospital, Zhengzhou

450054

SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan, Ufa

454048

Evimed Llc, Chelyabinsk

454087

"SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine", Chelyabinsk

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

510515

Nanfang Hospital of Southern Medical University, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

644013

"BHI of Omsk region Clinical Oncological Dispensary", Omsk

700094

Netaji Subhas Chandra Bose Cancer Hospital, Kolkata

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

730030

Lanzhou university second hospital, Lanzhou

2608717

Chiba cancer center, Chiba

5418567

Osaka International Cancer Institute, Osaka

06510

Yale-New Haven Hospital, New Haven

07109

New Jersey Cancer Care, P.A., Belleville

B1884BBF

COIBA, Berazategui

B2700CPM

Centro de Investigacion Pergamino SA - Clinica Pergamino SA, Pergamino

R8500ACE

Centro de Investigaciones Clínicas - Clínica Viedma, Viedma

T4000IAK

Centro Medico San Roque, San Miguel de Tucumán

C1426AGE

Centro Oncologico Korben, Caba

C1426ANZ

Instituto Médico Especializado Alexander Fleming, CABA

X5008HHW

Centro Medico Privado CEMAIC, Córdoba

Unknown

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD, Sofia

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

T2V 1P9

Prostate Cancer Centre, Calgary

B3H 2Y9

Centre of Applied Urology Research, Nova Scotia Health Authority, Halifax

N6A 5W9

London Health Sciences Centre, London

K1H 8L6

The Ottawa Hospital Cancer Center, Ottawa

M5G 2M9

University Health Network-Princess Margaret Cancer Centre, Toronto

G7H 5H6

CIUSSS- saguenay-Lac-Saint-Jean, Chicoutimi

J4V 2H3

Urology South Shore Research, Greenfield Park

H2X 0A9

CHUM - Centre Hospitalier de l'Université de Montréal, Montreal

H3T 1E2

Jewish General Hospital, Montreal

H4A 3J1

McGill University Health Center, Montreal

779 00

Fakultni nemocnice Olomouc, Olomouc

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

150 06

Fakultni nemocnice v Motole, Prague

180 81

Fakultni nemocnice Bulovka, Praha 8- Liben

00029

Helsinki University Hospital, Helsinki

00180

Docrates Cancer Center, Helsinki

07747

Universitätsklinikum Jena, Jena

04105

Uro-/Onkologisches Zentrum, Leipzig

466-8560

Nagoya University Hospital, Nagoya

036-8563

Hirosaki University School of Medicine & Hospital, Hirosaki

277-8577

National Cancer Center Hospital East, Kashiwa

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

737-0023

National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

920-8641

Kanazawa University Hospital, Kanazawa

232-0024

Yokohama City University Medical Center, Yokohama

238-8558

Yokosukakyosai, Yokosuka

589-8511

Kindai University Hospital, Sayama

565-0871

The University of Osaka Hospital, Suita

431-3192

Hamamatsu University Hospital, Hamamatsu

152-8902

National Hospital Organization Tokyo Medical Center, Meguro-Ku

160-8582

Keio university hospital, Shinjuku-ku

890-8520

Kagoshima University Hospital, Kagoshima

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

770-8503

Tokushima University Hospital, Tokushima

990-9585

Yamagata University Hospital, Yamagata

3813 TZ

Meander Medisch Centrum, Amersfoort

2545 AA

Stichting HagaZiekenhuis, The Hague

975 17

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, Banská Bystrica

833 10

Narodny onkologicky ustav, Bratislava

041 91

Vychodoslovensky onkologicky ustav, a.s., Košice

949 01

UROEXAM, spol. s r.o., Nitra

058 21

POKO Poprad s.r.o., Poprad

08 001

MILAB s.r.o., Prešov

911 01

Privatna urologicka ambulancia, s.r.o., Trenčín

0002

Clinical Research Unit, University of Pretoria, Pretoria

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital, Seoul

07985

Ewha Womans University Mokdong Hospital, Seoul

03203

Hospital General Universitario de Elche, Elche

08916

Hospital Germans Trias i Pujol, Badalona

08243

Althaia, Xarxa Assistencial Universitària de Manresa, Manresa

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

01415

Adana City Training and Research Hospital, Adana

06620

Ankara University Faculty of Medicine, Ankara

06800

Ankara City Hospital, Ankara

08720

"Medical & diagnostic center of LISOD-Israeli Oncological Hosp MedX-ray International Group", Pliuty Village

08173

Asklepion Medical Center, Khodosovka

03022

National Cancer Institute, Kyiv

EX2 5DW

Royal Devon and Exeter NHS Foundation Trust, Exeter

ME16 9QQ

Maidstone and Tunbridge Wells NHS Trust, Maidstone

PR2 9HT

Lancashire Teaching Hospitals NHS Foundation Trust, Preston

EH4 2XU

NHS Lothian, Edinburgh

S10 2SJ

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

B9 5SS

University Hospitals Birmingham NHS Foundation Trust, Birmingham

G12 0YN

NHS Greater Glasgow and Clyde, Glasgow

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

W6 8RF

Imperial College Healthcare NHS Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

lead

Pfizer

INDUSTRY

NCT04821622 - Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC | Biotech Hunter | Biotech Hunter