Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,054

Participants

Timeline

Start Date

December 18, 2017

Primary Completion Date

October 3, 2022

Study Completion Date

June 30, 2027

Conditions
mCRPC
Interventions
DRUG

Talazoparib with enzalutamide

Talazoparib 0.5 mg/day plus enzalutamide 160mg/day

DRUG

Placebo with enzalutamide

Placebo plus enzalutamide 160 mg/day

Trial Locations (355)

1023

Auckland City Hospital, Auckland

1082

Semmelweis Egyetem Urologiai Klinika, Budapest

1122

Országos Onkológiai Intézet, Budapest

1145

Uzsoki Utcai Korhaz, Budapest

Uzsoki Utcai Kórház, Budapest

1340

Clinique Saint-Pierre Ottignies, Ottignies

1478

Akershus University Hospital, Lorenskog

1712

Sykehusapoteket Ostfold, Kalnes, Grålum

1714

Ostfold County Hospital, Kalnes, Grålum

2010

St. Vincent's Hospital Sydney, Darlinghurst

2050

Chris O'Brien Lifehouse, Camperdown

2193

Wits Clinical Research, Parktown

2196

The Medical Oncology Centre of Rosebank, Johannesburg

2444

Port Macquarie Base Hospital, Port Macquarie

2930

AZ Klina, Brasschaat

3000

Peter MacCallum Cancer Centre, Melbourne

3051

Peter MacCallum Cancer Centre, North Melbourne

3112

Tauranga Urology Research Limited, Tauranga

3204

Waikato Hospital, Hamilton

4032

ICON Cancer Centre Chermside, Chermside

Debreceni Egyetem Klinikai Kozpont, Debrecen

4066

Icon Cancer Centre Wesley, Auchenflower

River City Pharmacy, Auchenflower

4101

ICON Cancer Centre South Brisbane, South Brisbane

Integrated Clinical Oncology Network Pty Ltd (ICON), South Brisbane

4102

Princess Alexandra Hospital, Brisbane

4215

ICON Cancer Centre Southport, Southport

5530

CHU UCL Namur site Godinne, Yvoir

6045

Cancercare Langenhoven Drive Oncology Centre, Port Elizabeth

6530

Outeniqua Cancercare Oncology Unit, George

7030

St. Olavs Hospital, Trondheim University Hospital, Trondheim

7570

Cape Town Oncology Trials, Kraaifontein

7624

Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet, Pécs

7700

Cancercare Rondebosch Oncology, Cape Town

8011

Canterbury District Health Board, Christchurch

8500

AZ Groeninge, Kortrijk

9000

A.Z. Sint-Lucas, Ghent

UZ Gent, Ghent

10043

AOU San Luigi Gonzaga, Orbassano

10408

Clinical Trial Pharmacy, National Cancer Center, Goyang-si

National Cancer Center, Goyang-si

10461

Montefiore Medical Center - Montefiore Medical Park, The Bronx

12603

Premier Medical Group of the Hudson Valley PC, Poughkeepsie

13210

Associated Medical Professionals of New York, PLLC, Syracuse

15102

UPMC Hillman Cancer Center - Upper St. Clair, Bethel Park

15146

UPMC Hillman Cancer Center - Monroeville, Monroeville

15232

UPMC Hillman Cancer Center, Pittsburgh

15237

UPMC Hillman Cancer Center - Passavant (HOA), Pittsburgh

UPMC Hillman Cancer Center - Passavant (OHA), Pittsburgh

15301

UPMC Hillman Cancer Center - Washington, Washington

15401

UPMC Hillman Cancer Center - Uniontown, Uniontown

15601

UPMC Hillman Cancer Center - Arnold Palmer - Mt View, Greensburg

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

16346

UPMC Hillman Cancer Center - Northwest, Seneca

16601

UPMC Hillman Cancer Center - Altoona, Altoona

17176

Karolinska Universitetssjukhuset, Solna

17604

Keystone Urology Specialists, Lancaster

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

20520

Turku University Hospital, Turku

22031

Inova Schar Cancer Institute Infusion Pharmacy, Fairfax

Inova Schar Cancer Institute, Fairfax

26100

ASST di Cremona, Cremona

28006

Hospital Universitario La Princesa, Madrid

28009

Hospital General Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Center, Madrid

28041

Hospital Universitario 12 De Octubre, Madrid

29572

Carolina Urologic Research Center, Myrtle Beach

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

30214

Piedmont Cancer Institute, Fayetteville

30265

Piedmont Cancer Institute, Newnan

Southeastern Regional Medical Center, Newnan

30318

Piedmont Cancer Institute, Atlanta

32117

Florida Cancer Specialists, Daytona Beach

32159

Florida Cancer Specialists, The Villages

32605

Florida Cancer Specialists, Gainesville

32701

Florida Cancer Specialists, Altamonte Springs

32763

Florida Cancer Specialists, Orange City

32778

Florida Cancer Specialists, Tavares

32792

Florida Cancer Specialists, Winter Park

32804

AdventHealth Medical Group Hermatology and Oncology, Orlando

Investigational Drug Services, Advent Health Orlando, Orlando

32806

Florida Cancer Specialists, Orlando

32960

Florida Cancer Specialists, Vero Beach

33075

Hopital Saint Andre - CHU de Bordeaux, Bordeaux

33401

Florida Cancer Specialists, West Palm Beach

33414

Florida Cancer Specialists, Wellington

33511

Florida Cancer Specialists, Brandon

33520

Tampere University Hospital, Tampere

33607

Florida Cancer Specialists, Tampa

33705

Florida Cancer Specialists, St. Petersburg

33761

Florida Cancer Specialists, Clearwater

33770

Florida Cancer Specialists, Largo

33805

Lakeland Regional Health Hollis Cancer Center, Lakeland

33905

Florida Cancer Specialists, Fort Myers

34295

CHU Montpellier-Hopital Saint Eloi, Montpellier

34461

Florida Cancer Specialists, Lecanto

34471

Florida Cancer Specialists, Ocala

34608

Florida Cancer Specialists, Spring Hill

34655

Florida Cancer Specialists, New Port Richey

34994

Florida Cancer Specialists, Stuart

37209

Urology Associates P.C., Nashville

37232

The Vanderbilt Clinic, Nashville

Vanderbuilt University Medical Center, Department of Urology, Nashville

37311

Tennesse Oncology, PLLC, Cleveland

37404

Greco-Hainesworth Tennessee Oncology Centers for Research, Chattanooga

Tennessee oncology, PLLC, Chattanooga

38122

Ospedale Santa Chiara, Trento

40138

Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi, Bologna

40225

Universitaetsklinikum Duesseldorf, Düsseldorf

41404

Kyungpook National University Chilgok Hospital, Daegu

44130

Clinical Research Solutions, Middleburg Heights

45212

TriState urologic Services PSC Inc., dba The Urology Group, Cincinnati

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola

47130

Clark Memorial Hospital Radiology, Jeffersonville

First Urology, PSC, Jeffersonville

48149

Universitaetsklinikum Muenster, Münster

49241

Pusan National University Hospital, Busan

52242

University of Iowa Hospital and Clinics, Iowa City

53792

University of Wisconsin Clinical Science Center, Madison

University of Wisconsin Hospital & Clinics, Madison

60099

Midwestern Regional Medical Center, Zion

60521

AMITA Health Adventist Medical Center Hinsdale, Hinsdale

AMITA Health Cancer Institute, Hinsdale

60612

Cook County Health (CCH), Chicago

John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy, Chicago

63106

VA Saint Louis Healthcare System, St Louis

64100

Centre d'Oncologie du Pays-Basque, Bayonne

Clinique Ramsay Belharra, Bayonne

66205

The University of Kansas Clinical Research Center, Fairway

The University of Kansas Cancer Center, Westwood

67000

Clinique Sainte Anne, Strasbourg

67200

Hopitaux Universitaires de Strasbourg - ICANS, Strasbourg

68130

XCancer Omaha / Urology Cancer Center, PC d/b/a XCancer, Omaha

69120

Universitaetsklinik Heidelberg, Heidelberg

69373

Centre Léon Bérard, Lyon

70121

Ochsner Clinic Foundation, New Orleans

70210

Kuopio University Hospital, Kuopio

72000

Clinique Victor Hugo Le Mans, Le Mans

72622

Studienpraxis Urologie, Nürtingen

73104

OU Health Stephenson Cancer Center, Oklahoma City

73230

Diagnostikzentrum, Kirchheim

75010

Hopital Saint-Louis, Paris

75908

Hopital Europeen Georges Pompidou, Paris

76508

Baylor Scott & White Medical Center - Temple, Temple

77027

Houston Metro Urology, Houston

78681

Urology Austin, PLLC, Round Rock

78745

Urology Austin PLLC, Austin

79912

Rio Grande Urology, P.A., El Paso

80045

University of Colorado Denver CTO/CTRC, Aurora

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora

University of Colorado Hospital- Anschutz Inpatient Pavilion, Aurora

University of Colorado Hospital- Anschutz Outpatient Pavilion, Aurora

University of Colorado Hospital, Aurora

80131

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

80211

The Urology Center of Colorado, Denver

84025

Farmington Health Center -University of Utah, Farmington

84095

South Jordan Health Center -University of Utah, South Jordan

84112

Huntsman Cancer Hospital, Salt Lake City

University of Utah, Huntsman Cancer Institute, Salt Lake City

84119

Redwood Health Center-University of Utah, Salt Lake City

85202

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Mesa

85206

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Mesa

85224

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Chandler

85260

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Scottsdale

85297

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers, Gilbert

85715

Arizona Urology Specialists, Tucson

85741

Arizona Urology Specialists, Tucson

85925

CHD Vendée, La Roche-sur-Yon

87109

Urology Group of New Mexico, Albuquerque

87401

San Juan Oncology Associates, Farmington

90095

UCLA Clark Urology Center, Los Angeles

90211

Beverly Hills Cancer Center, Beverly Hills

90220

Oulun yliopistollinen sairaala, Oulu

90822

VA Long Beach Healthcare System, Long Beach

91206

Glendale Adventist Medical Center, Glendale

91911

South County Hematology/Oncology, Chula Vista

91913

Sharp Rees-Stealy, Chula Vista

91942

Cancer Center Oncology Medical Group, La Mesa

92123

Medical Oncology Associates-SD, San Diego

Sharp Memorial Hospital Investigational Pharmacy, San Diego

Sharp Rees-Stealy, San Diego

92150

Hopital Foch, Suresnes

92151

Hopital Foch, Suresnes

92270

Desert Hematology Oncology Medical Group, Incorporation, Rancho Mirage

Eisenhower Medical Center, Rancho Mirage

92350

Loma Linda University Cancer Center - Records Management Only, Loma Linda

92354

Loma Linda University Cancer Center - Hematology/Oncology Clinic, Loma Linda

Loma Linda University Medical Center, Loma Linda

92868

University of California, Irvine Medical Center, Orange

94304

Stanford Cancer Institute, Palo Alto

94305

Stanford Health Care, Stanford

94805

Institut Gustave Roussy, Villejuif

94904

Marin Cancer Care, Inc., Greenbrae

97015

Kaiser Sunnyside Medical Center, Clackamas

97045

Providence Cancer Institute Willamette Falls, Oregon City

97124

Kaiser Westside Medical Center, Hillsboro

97132

Providence Cancer Institute Newberg Clinic, Newberg

Providence Newberg Medical Center, Newberg

97213

Providence Cancer Institute Franz Clinic, Portland

Providence Portland Medical Center, Portland

97225

Providence Oncology and Hematology Care Clinic - Westside, Portland

Providence St Vincent Medical Center, Portland

97227

Kaiser Permanente Northwest, Portland

98104

Swedish Cancer Institute, Seattle

98122

Swedish Medical Center, Seattle

99503

Alaska Urological Institute dba Alaska Clinical Research Center, Anchorage

100010

Beijing Hospital, Beijing

100021

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

100034

Peking University First Hospital / Urology Department, Beijing

100142

Beijing Cancer Hospital, Beijing

100191

Peking University Third Hospital, Beijing

130000

Jilin Cancer Hospital, Changchun

200025

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

200032

Zhongshan Hospital Fudan University, Shanghai

Fudan University Cancer Hospital, Deptartment of Urology, Shanghai

200072

Shanghai Tenth People's Hospital, Shanghai

200080

Shanghai General Hospital, Shanghai

201100

The Fifth People's Hospital of Shanghai, Fudan University, Shanghai

210006

Nanjing First Hospital, Nanjing

210008

Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School, Nanjing

210012

Nanjing First Hospital, Nanjing

214023

Wuxi People's Hospital, Wuxi

222500

The First People's Hospital of Lianyungang, Lianyungang

226000

Nantong Tumor Hospital, Nantong

230022

The First affiliated Hospital of Anhui Medical University, Hefei

300211

The Second Hospital of Tianjin Medical University, Tianjin

310014

Zhejiang Provincial People's Hospital, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

315010

The first affiliated hospital of Ningbo university, Ningbo

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350005

The First Affiliated Hospital Of Fujian Medical University, Fuzhou

361003

First Affiliated Hospital of Xiamen University, Xiamen

400030

Chongqing University Cancer Hospital, Chongqing

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

610041

West China Hospital of Sichuan University, Chengdu

650118

Yunnan Cancer Hospital, Kunming

710061

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

2540488

Centro de Investigaciones Clinicas Vina del Mar, Viña del Mar

2540634

Centro de Investigaciones Clinicas Vina del Mar, Viña del Mar

3109601

Rambam Health Care Campus, Haifa

4781156

Centro de Investigacion Clinica del Sur, Temuco

4800827

James Lind Centro de Investigación del Cáncer, Araucania

5418567

Osaka International Cancer Institute, Osaka

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

7500713

Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia), Santiago

9103102

Shaare Zedek Medical Center, Jerusalem

07109

Clara Maass Medical Center, Belleville

New Jersey Cancer Care and Blood Disorders, Belleville

07110

University Radiology, Nutley

08043

New Jersey Urology, LLC, Voorhees Township

B2700CPM

Centro de Investigacion Pergamino SA - Clinica Pergamino SA, Pergamino

S2000KZE

Instituto de Oncologia de Rosario, Rosario

C1280AEB

Hospital Británico de Buenos Aires, Caba

C1431FWO

"Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno Cemic", Caba

X5004FHP

Clinica Universitaria Reina Fabiola, Córdoba

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

20230-130

Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA, Rio de Janeiro

20231-050

Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA, Rio de Janeiro

20551-030

Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA), Rio de Janeiro

22031-011

Hospital CopaDor, Rio de Janeiro

22211-230

Hospital Gloria D'Or, Rio de Janeiro

22251-040

Oncologia D'Or, Rio de Janeiro

22281-100

Instituto D'Or de Pesquisa e Ensino, Rio de Janeiro

22291-110

Oncologia D'Or, Rio de Janeiro

98700-000

Associacao Hospital de Caridade de Ijui, Ijuí

95900-022

Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born, Lajeado

90610-000

Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica, Porto Alegre

90850-170

Centro Gaucho Integrado - Hospital Mae de Deus, Porto Alegre

91010-004

MedPlex Eixo Norte, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao, Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos

09060-650

Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa de Hematologia e Oncologia (CEPHO), Santo André

09060-870

Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO), Santo André

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa, São Paulo

01327-001

Hospital Alemão Oswaldo Cruz, São Paulo

T2N 5G2

Arthur J.E Child Comprehensive Cancer Centre, Calgary

K1H 8L6

The Ottawa Hospital Cancer Center, Ottawa

G7H 5H6

Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi

H2X 3E4

CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal

H3T 1E2

Jewish General Hospital, Montreal

J1H 5N4

Centre integre universitaire de sante et de services sociaux de l'Estrie, Sherbrooke

Unknown

Second Affiliated Hospital of Suzhou University, Suzhou

Clinica Monte Carmelo S.C.R.LTDA., Arequipa

500 05

Fakultní nemocnice Hradec Králové, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava-Poruba

532 03

Multiscan s.r.o., Pardubice

100 34

Fakultní nemocnice Královské Vinohrady, Prague

00029

HUS Helsinki University Hospital, Helsinki

00180

Docrates Cancer Center, Helsinki

05100

Azienda Ospedaliera S. Maria, Terni

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

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

Yokosuka Kyosai Hospital, Yokosuka

589-8511

Kindai University Hospital, Sayama

565-0871

Osaka University Hospital, Suita

431-3192

Hamamatsu University School of Medicine, University Hospital, Hamamatsu

152-8902

National Hospital Organization Tokyo Medical Center, Meguro-ku

160-8582

Keio University Hospital, Shinjuku-ku

260-8717

Chiba Cancer Center, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

890-8520

Kagoshima University Hospital, Kagoshima

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

770-8503

Tokushima University Hospital, Tokushima

990-2292

Yamagata Prefectural Central Hospital, Yamagata

990-9585

Yamagata University Hospital, Yamagata

0379

Oslo University Hospital -Ullevål & Radiumhospitalet, Oslo

Lima 11

"Hospital Militar Central Coronel Luis Arias Schreiber", Lima

Lima 41

Clinica Internacional Sede San Borja, Lima

Clinica Oncosalud, Lima

36-200

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza, Brzozów

81-519

Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii, Gdynia

62-500

"Przychodnia Lekarska Komed Roman Karaszewski", Konin

05-400

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Otwock

02-473

City Clinic Sp. z o.o., Warsaw

02-797

NZOZ Szpital Mazovia; Oddzial urologiczny, Warsaw

4710-243

Centro Clínico Académico - Braga, Associação (2CABraga), Braga

3000-075

Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E, Coimbra

1400-038

Fundação Champalimaud, Lisbon

1500-650

Hospital da Luz Lisboa, Lisbon

4099-001

Centro Hospitalar do Porto - Hospital de Santo Antonio, Porto

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, Porto

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

Cancer Center Clinical Trial, Asan Medical Center, Seoul

06351

Clinical Trials Center Pharmacy, Seoul

Samsung Medical Center, Seoul

06591

Clinical Trial Pharmacy, The Catholic University of Korea, Seoul

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

03203

Hospital General Universitario de Elche, Elche

08908

Institut Catala d'Oncologia - ICO L'Hospitalet, L'Hospitalet de Llobregat

08208

Corporacio Sanitaria i Universitaria Parc Tauli, Sabadell

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

901 85

Cancercentrum, Umeå

PL6 8DH

University Hospitals Plymouth NHS Trust, Plymouth

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

G12 0XH

Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital, Glasgow

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington

TR1 3LJ

Royal Cornwall Hospitals NHS Trust, Cornwall

L7 8YA

The Clatterbridge Cancer Centre - Liverpool, Liverpool

W12 0HS

Imperial College Healthcare NHS Trust, London

W2 1NY

Imperial College Healthcare NHS Trust, London

W6 8RF

Imperial College Healthcare NHS Trust, Charing Cross Hospital, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

lead

Pfizer

INDUSTRY

NCT03395197 - Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC | Biotech Hunter | Biotech Hunter