A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

Condition: Metastatic Prostate Cancer

Intervention:

Drug: Niraparib
Drug: Abiraterone Acetate
Drug: Prednisone
Drug: Placebo

Purpose: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03748641

Sponsor: Janssen Research & Development, LLC

Primary Outcome Measures:

Measure: Radiographic Progression Free Survival (rPFS)
Time Frame: Approximately 40 months
Safety Issue:

Secondary Outcome Measures:

Measure: Overall survival (OS)
Time Frame: Approximately up to 73 months
Safety Issue:
Measure: Time to Chronic Opioid Use
Time Frame: Approximately up to 73 months
Safety Issue:
Measure: Time to Pain Progression
Time Frame: Approximately up to 73 months
Safety Issue:
Measure: Time to Initiation of Cytotoxic Chemotherapy
Time Frame: Approximately up to 73 months
Safety Issue:
Measure: Observed Plasma Concentrations of Niraparib
Time Frame: Cycle 2: Day 1 (Predose, between 1 to 3 and 3 to 6 hours postdose); Cycle 3: Day 1 (Predose); Cycles 4 to 7: Day 1 (Predose or at least 3 hours postdose); each Cycle of 28 days
Safety Issue:
Measure: Observed Trough Plasma Concentrations of Abiraterone
Time Frame: Cycles 2 and 3 (Each Cycle of 28 days): Day 1 (Predose)
Safety Issue:
Measure: Number of Participants with Treatment-Emergent Adverse events (TEAEs)
Time Frame: Approximately up to 73 months
Safety Issue:
Measure: Number of Participants with Treatment-Emergent Adverse events by Severity
Time Frame: Approximately up to 73 months
Safety Issue:
Measure: Number of Participants with Laboratory Abnormalities as Measure of Safety
Time Frame: Approximately up to 73 months
Safety Issue:

Estimated Enrollment: 1000

Study Start Date: January 25, 2019

Phase: Phase 3

Eligibility:

Age: minimum 18 Years maximum N/A
Gender: Male

Inclusion Criteria:

Deoxyribonucleic acid (DNA)-repair gene defects (DRD) status (as identified by the sponsor’s required assays) as follows: 1. Cohort 1: positive for DRD 2. Cohort 2: not positive for DRD (i.e. No DRD)
Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
Progression of metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry as evidenced by prostate-specific antigen (PSA) progression or radiographic progression
Able to continue GnRHa during the study if not surgically castrate
Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion Criteria:

Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
Systemic therapy (example, enzalutamide, docetaxel) in the metastatic castration-resistant prostate cancer (mCRPC) setting with the exception of less than 4 months of abiraterone acetate-Prednisone (AA-P) prior to randomization
Symptomatic brain metastases
History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Contact:

Study Contact
844-434-4210

Locations:

Urological Associates of Southern Arizona, P.C.
Tucson Arizona 85741 United States

San Bernardino Urological Associates
San Bernardino California 92404 United States

University of California San Francisco
San Francisco California 94158 United States

Kaiser Permanente Medical Center
Vallejo California 95119 United States

Urology Associates of Denver
Englewood Colorado 80113 United States

Foothills Urology – Golden Off
Golden Colorado 80401-5027 United States

VA Connecticut Healthcare
West Haven Connecticut 06516 United States

Bay Pines VA Healthcare System
Bay Pines Florida 33744 United States

Advanced Urology Institute
Daytona Beach Florida 32114 United States

University of Florida
Jacksonville Florida 32209 United States

Veterans Affairs Medical Ctr
Hines Illinois 60141 United States

University of Kansas Medical Center
Kansas City Kansas 66160 United States

Norton Healthcare
Louisville Kentucky 40202 United States

Rcca Md, Llc
Bethesda Maryland 20817 United States

Chesapeake Urology Research Associates
Towson Maryland 21204 United States

Massachusetts General
Boston Massachusetts 02114 United States

Kansas City Veterans Affairs Medical Center
Kansas City Missouri 64128 United States

Adult Pediatric Urology & Urogynecology, P.C
Omaha Nebraska 68114 United States

Comprehensive Cancer Centers of Nevada
Las Vegas Nevada 89169 United States

Delaware Valley Urology, LLC
Mount Laurel New Jersey 08054 United States

Icahn School of Medicine at Mount Sinai – The Derald H. Ruttenberg
New York New York 10029 United States

Memorial Sloan Kettering Cancer Center
New York New York 10065 United States

Upstate Cancer Center
Syracuse New York 13210 United States

Lancaster Urology
Lancaster Pennsylvania 17604 United States

VA Pittsburgh
Pittsburgh Pennsylvania 15240 United States

Carolina Urologic Research Center
Myrtle Beach South Carolina 29572 United States

University of Texas MD Anderson Cancer Center
Houston Texas 77030 United States

Utah Cancer Specialists
Salt Lake City Utah 84106 United States

Salem VA Medical Center
Salem Virginia 80113 United States

Urology of Virginia, PLCC
Virginia Beach Virginia 23462 United States

NorthWest Medical Specialties, PLLC
Tacoma Washington 98405 United States

Hospital Aleman
Buenos Aires C1118AAT Argentina

Hospital Italiano de Buenos Aires
C.a.b.a. C1181ACF Argentina

Fundación CENIT para la Investigación en Neurociencias
Capital Federal CP 1125 Argentina

Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires C1120AAT Argentina

CEMIC Saavedra
Ciudad Autonoma Buenos Aires C1431FWN Argentina

Cemaic – Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba 5000 Argentina

Hospital Privado – Centro Medico de Cordoba
Cordoba X5016KEH Argentina

Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata B7600FZN Argentina

Hospital Privado de Comunidad
Mar del Plata B7602CBM Argentina

Centro de Investigacion Pergamino SA
Pergamino B2700CPM Argentina

Sanatorio Britanico de Rosario
Rosario 2000 Argentina

Sanatorio Parque
Rosario S2000SDV Argentina

ARS Médica
San Salvador de Jujuy Y4600AFW Argentina

Royal Adelaide Hospital
Adelaide 5116 Australia

Pindara Private Hospital
Benowa 4217 Australia

Sunshine Coast University Hospital
Birtinya 4575 Australia

Princess Alexandra Hospital
Brisbane 4102 Australia

Chris O’Brien Lifehouse
Camperdown 2050 Australia

St. Vincent’s Hospital Sydney
Darlinghurst 2010 Australia

Royal Hobart Hospital
Hobart 7000 Australia

Macquarie University
Macquarie University 2109 Australia

Cabrini Health
Malvern 3144 Australia

Peter MacCallum Cancer Centre
Melbourne 3000 Australia

Fiona Stanley Hospital
Murdoch 6150 Australia

Hollywood Private Hospital
Nedlands 6009 Australia

Prince Of Wales Hospital
Randwick 2031 Australia

Sydney Adventist Hospital
Wahroonga 2076 Australia

Wollongong Private Hospital
Wollongong 2500 Australia

OLV Ziekenhuis Aalst
Aalst 9300 Belgium

ZNA Middelheim
Antwerpen 2020 Belgium

Grand Hôpital de Charleroi, site Notre Dame
Charleroi 6000 Belgium

AZ Maria Middelares
Gent 9000 Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege B-4000 Belgium

Hospital Do Cancer De Barretos – Fundacao Pio Xii
Barretos 14784-400 Brazil

PERSONAL – Oncologia de Precisão e Personalizada
Belo Horizonte 30130-090 Brazil

Hospital Sírio Libanes Unidade Brasilia
Brasilia 70200-730 Brazil

CIONC – Centro Integrado de Oncologia de Curitiba
Curitiba 80810-050 Brazil

Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
Goiânia 74605-070 Brazil

Hospital de Caridade de Ijui – CACON
Ijui 98700-000 Brazil

Clínica de Neoplasias Litoral Ltda.
Itajai 88301-220 Brazil

Instituto Joinvilense De Hematologia e Oncologia
Joinville 89201260 Brazil

Centro de Tratamento de câncer Medradius
Maceió 57052-765 Brazil

Liga Norte Riograndense Contra O Cancer
Natal 59075-740 Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre 90020-090 Brazil

Instituto Nacional do Cancer – INCA
Rio de Janeiro 20230-130 Brazil

Hospital Universitário Pedro Ernesto
Rio de Janeiro 20551-030 Brazil

Instituto COI de Pesquisa, Educação e Gestão
Rio de Janeiro 22793-080 Brazil

Hospital Santa Isabel
Salvador 40050-410 Brazil

CEPHO – Faculdade de Medicina do ABC
Santo André 09060-870 Brazil

Santa Casa de Misericordia de São Paulo
Sao Paulo 01221-020 Brazil

Instituto de Ensino E Pesquisa Sao Lucas
Sao Paulo 01236-030 Brazil

ICESP – INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA
Sao Paulo 01246-000 Brazil

Fundacao Antonio Prudente
Sao Paulo 01509900 Brazil

IBCC Instituto Brasileiro de Controle do Cancer
Sao Paulo 03102-002 Brazil

IOS – Instituto de Oncologia de Sorocaba “Dr. Gilson Delgado”
Sorocaba 18030-075 Brazil

Instituto de Assistência Médica ao Servidor Público Estadual – HSPE-FMO
São Paulo 04039-004 Brazil

Instituto do Cancer De Tres Lagoas
Três Lagoas 79601-001 Brazil

Instituto do Cancer De Tres Lagoas
Três Lagoas 79603110 Brazil

MHAT Deva Maria
Burgas 8001 Bulgaria

UMHAT ‘Dr. Georgi Stranski’, EAD
Pleven 5800 Bulgaria

Complex Oncology Center – Plovdiv EOOD
Plovdiv 4004 Bulgaria

Specialized Hospital for Active Treatment in Oncology EAD
Sofia 1756 Bulgaria

SHATOD ‘Dr. Marko Antonov Markov’
Varna 9010 Bulgaria

Comprehensive Cancer Center
Vratsa 3001 Bulgaria

Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary Alberta T2V 1P9 Canada

British Columbia Cancer Agency (BCCA) – Vancouver Centre
Vancouver British Columbia V5Z 4E6 Canada

British Columbia Cancer Agency – Vancouver Island Centre
Victoria British Columbia V8R 6V5 Canada

McMaster Institute of Urology
Hamilton Ontario L8N 4A6 Canada

Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
Kingston Ontario K7L 3N6 Canada

Sunnybrook Health Sciences Center
Toronto Ontario M4N 3M5 Canada

University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario M5G 2M9 Canada

Centre de Recherche du CHUM
Montreal Quebec H2X 0A9 Canada

Saskatoon Cancer Centre
Saskatoon Saskatchewan S7N 4H4 Canada

Cancer Hospital Chinese Academy of Medical Sciences
Beijing 100021 China

Peking University First Hospital
Beijing 100034 China

Beijing Friendship Hospital
Beijing 100050 China

Beijing Cancer Hospital of Peking University
Beijing 100142 China

Peking University Third Hospital
Beijing 100191 China

Beijing Hospital
BeiJing 100730 China

Sichuan Provincial People’s Hospital
Chengdu 610072 China

Southwest Hospital, The Third Military Medical University
Chongqing 400025 China

Chongqing Cancer hospital
Chongqing 400030 China

Fujian Medical University Union Hospital
Fuzhou 350001 China

Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou 510120 China

Guangzhou First Municipal People’s Hospital
GuangZhou 510180 China

The First Affiliated hospital of Anliui Medical University
Hefei China

Nanjing Drum Tower Hospital
Nanjing 210008 China

Jiangsu Cancer Hospital
Nanjing 210009 China

Drug clinical trial ethics committee of Ningbo First Hospital
Ningbo 315010 China

Fudan University Shanghai Cancer Center
Shanghai 200032 China

Shanghai Zhongshan Hospital
ShangHai 200032 China

Huashan Hospital Fudan University
Shanghai 200040 China

ShangHai Huadong Hospital
ShangHai 200040 China

Renji Hospital, Shanghai Jiaotong University School of Medicine
ShangHai 200127 China

The Fifth People’s Hospital of Shanghai, Fudan University
ShangHai 200240 China

The First Affiliated Hospital of Soochow University
Suzhou 215006 China

Tianjin Medical University Cancer Hospital
Tianjin 300060 China

The Central Hospital of Wuhan
Wuhan 430014 China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan 430030 China

Wuxi People’s Hospital
Wuxi 214023 China

First Affiliated Hospital, Xi’an Jiaotong University
Xi’an 710061 China

Fakultni nemocnice Hradec Kralove
Hradec Králove 500 05 Czechia

Krajská nemocnice Liberec
Liberec 460 63 Czechia

Uromedical Center s.r.o.
Olomouc 77900 Czechia

Multiscan s.r.o.
Pardubice 53203 Czechia

Fakultni nemocnice Plzen, Urologicka klinika
Plzen 305 99 Czechia

Urologicka klinika 1.LF UK a VFN
Praha 2 120 00 Czechia

Thomayerova nemocnice, Onkologicka klinika
Praha 4 140 59 Czechia

CHRU De Besancon
Besancon 25030 France

Institut Bergonié
Bordeaux 33000 France

Centre Jean Perrin
Clermont Ferrand 63011 France

Centre Leon Bérard
Lyon 69008 France

Institut Regional du Cancer de Montpellier Val d’Aurelle
Montpellier 34298 France

Polyclinique de Gentilly
Nancy 54100 France

Centre Antoine Lacassagne
Nice Cedex 2 06189 France

Hopital Europeen Georges-Pompidou
Paris Cedex 15 75908 France

Institut de Cancérologie de l’Ouest (ICO)
Saint Herblain 44805 France

HIA Begin
Saint Mande 94163 France

Hôpitaux Universitaire de Strasbourg -CHU
Strasbourg 67091 France

Charite – Universitatsmedizin Berlin (CCM)
Berlin 12200 Germany

Städtisches Klinikum Braunschweig gGmbH – Standort Salzdahlumer
Braunschweig 38126 Germany

Urologicum Duisburg
Duisburg 47179 Germany

Universitätsklinikum des Saarlandes
Homburg 66424 Germany

Klinik und Poliklinik für Urologie
Köln 50937 Germany

Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
Magdeburg 39120 Germany

Universitaetsklinikum Muenster
Muenster 48149 Germany

Studienpraxis Urologie Drs. Feyerabend
Nuertingen 72622 Germany

Semmelweis Egyetem, Urológia Klinika
Budapest 1082 Hungary

Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest 1122 Hungary

Szent János Kórház és Észak-budai Egyesített Kórházak
Budapest 1125 Hungary

Debreceni Egyetem Klinikai Kozpont
Debrecen 4032 Hungary

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
Gyula 5700 Hungary

Uro-Clin Kft.
Pécs 7621 Hungary

Szegedi Tudomanyegyetem
Szeged 6725 Hungary

Asaf Harofe Medical Center
Beer Yaakov 60930 Israel

Rambam Health Care Campus
Haifa 31096 Israel

Rabin Medical Center
Petah Tikva 49100 Israel

Sheba Medical Center Tel Hashomer
Ramat Gan 52621 Israel

AUSL Romagna – Ospedale di Faenza
Faenza 48018 Italy

Ospedale San Raffaele
Milano 20132 Italy

ASST Grande Ospedale Metropolitano Niguarda
Milano 20162 Italy

Oncologia Medica A – Ist Naz Tumori G Pascale
Napoli 80131 Italy

Istituto Oncologico Veneto Iov Irccs Padova
Padova 35128 Italy

Oncologia Medica – Azienda Ospedaliero Universitaria Di Parma
Parma 43126 Italy

Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
Perugia 06132 Italy

Azienda Ospedaliero Universitaria Pisana
Pisa 56126 Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma 00168 Italy

Campus Bio-Medico di Roma
Roma 128 Italy

Azienda Ospedaliera S. Maria Terni
Terni 5100 Italy

A.O.U. Città della Salute e della Scienza
Torino 10126 Italy

Ospedale Santa Chiara Trento
Trento 38122 Italy

Pusan National University Hospital.
Busan 49241 Korea, Republic of

Kyungpook National University Chilgok Hospital
Daegu 41404 Korea, Republic of

Keimyung University Dongsan Hospital
Daegu 42601 Korea, Republic of

Chungnam National University Hospital
Daejeon 35015 Korea, Republic of

National Cancer Center
Goyang-Si 10408 Korea, Republic of

Chonnam National University Hospital
Gwangju 61469 Korea, Republic of

Seoul National University Bundang Hospital
Seongnam-si 13620 Korea, Republic of

Seoul National University Hospital
Seoul 03080 Korea, Republic of

Severance Hospital
Seoul 03722 Korea, Republic of

Asan Medical Center
Seoul 05505 Korea, Republic of

Gangnam Severance Hospital
Seoul 06273 Korea, Republic of

Samsung Medical Center
Seoul 06351 Korea, Republic of

Seoul St. Mary’s Hospital
Seoul 06591 Korea, Republic of

Ajou University Hospital
Suwon 443-721 Korea, Republic of

Hospital Pulau Pinang
George Town 10990 Malaysia

Hospital Sultan Ismail
Johor Bahru 81100 Malaysia

Hospital Likas
Kota Kinabalu 88996 Malaysia

Hospital Kuala Lumpur
Kuala Lumpur 53000 Malaysia

University Malaya Medical Centre
Kuala Lumpur 59100 Malaysia

Sarawak General Hospital
Kuching 93586 Malaysia

iBiomed Research Unit
Aguascalientes 20010 Mexico

Mexico Centre for Clinical Research, S.A. de C.V.
Ciudad de Mexico 03100 Mexico

Consultorio de Especialidad en Urologia Privado
Durango 34000 Mexico

Centro Medico Nacional Siglo XXI IMSS
Mexico 06720 Mexico

Avix Investigacion Clinica, S.C.
Monterrey 64710 Mexico

Consultorio Privado
Zapopan 45040 Mexico

NKI-AVL, Amsterdam
Amsterdam 1066 CX Netherlands

Universitair Medisch Centrum Groningen
Groningen 9713 GZ Netherlands

Atrium Medisch Centrum – Parkstad
Heerlen 6419 PC Netherlands

MC Haaglanden Lok Antoniushove – Afd.Interne – INT
Leidschendam 2262 BA Netherlands

St. Antonius Ziekenhuis (St. Antonius Hospital)
Nieuwegein 3430EM Netherlands

Canisius-Wilhelminaziekenhuis
Nijmegen 6532 SZ Netherlands

Erasmus MC
Rotterdam 3075 EA Netherlands

Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
Bydgoszcz 85-094 Poland

Centrum Onkologii im. Prof. F. Lukaszczyka
Bydgoszcz 85-796 Poland

Uniwersyteckie Centrum Kliniczne
Gdańsk 80-952 Poland

Szpitale Pomorskie Sp. z o.o.
Gdynia 81-519 Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz 93-509 Poland

Wielkopolskie Centrum Onkologii
Poznan 61-866 Poland

Urologica Praktyka Lekarska Adam Marcheluk
Siedlce 08-110 Poland

Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin 70-111 Poland

Szpital Św. Elżbiety Mokotowskie Centrum Medyczne
Warszawa 02-616 Poland

Centrum Onkologii – Instytut im. M. Sklodowskiej-Curie
Warszawa 02‐781 Poland

Dolnoslaskie Centrum Onkologii
Wrocław 53-413 Poland

Hospitais da universidade de Coimbra
Coimbra 3000-075 Portugal

Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra 3000-075 Portugal

Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
Lisboa 1649-035 Portugal

Champalimaud Foundation Champalimaud Centre
Lisbon 1400-038 Portugal

H. Santo António – Centro Hospitalar do Porto
Porto 4099-001 Portugal

VA Caribbean Healthcare System
San Juan 00921 Puerto Rico

Altai Regional Oncology Dispensary
Barnaul 656049 Russian Federation

Ivanovo Regional Oncology Dispensary
Ivanovo 153040 Russian Federation

Naval Clinical Hospital
Kaliningrad 236029 Russian Federation

State Health Establishment Kursk Regional Oncology Dispensary
Kursk 305035 Russian Federation

Russian Scientific Center of Roentgenoradiology
Moscow 117997 Russian Federation

Moscow City Clinical Hospital # 62
Moscow 125130 Russian Federation

Clinical Diagnostic Centre of Nizhny Novgorod Region
Nizhny Novgorod 603000 Russian Federation

Clinical Oncology Dispensary
Omsk 644013 Russian Federation

LLC Novaya Clinica
Pyatigorsk 357500 Russian Federation

Pyatigorsk Regional Oncology Dispensary
Pyatigorsk 357502 Russian Federation

Private Medical Institution Euromedservice
Saint Petersburg 196603 Russian Federation

Leningrad Regional Oncology Dispensary
Saint-Petersburg 191104 Russian Federation

Russian Scientific Center of Radiology and Surgical Technologies
Saint-Petersburg 197758 Russian Federation

Republican Oncology Dispensary
Saransk 430032 Russian Federation

Oncologic Dispensary No.2
Sochi 354057 Russian Federation

Tambov Regional Oncology Clinical Dispansary
Tambov 392013 Russian Federation

Tomsk Cancer Research Institute
Tomsk 634050 Russian Federation

Medical-sanitary unit ‘Neftyanik’
Tyumen 625000 Russian Federation

Vologda Regional Oncological Dispensary
Vologda 160012 Russian Federation

Clinresco Centres Pty Ltd
Johannesburg 1619 South Africa

Clinical Research Unit
Pretoria 0001 South Africa

East Rand Urology Research Unit
Vosloorus 1475 South Africa

Hosp. Del Mar
Barcelona 08003 Spain

Hosp. de La Santa Creu I Sant Pau
Barcelona 08025 Spain

Hosp. Clinic I Provincial de Barcelona
Barcelona 08036 Spain

Hospital Juan Canalejo
Coruña 15006 Spain

Hosp. de Jerez de La Frontera
Jerez de la Frontera 11407 Spain

Hosp. Gral. Univ. Gregorio Maranon
Madrid 28007 Spain

Hosp. Univ. Ramon Y Cajal
Madrid 28034 Spain

Hosp. Clinico San Carlos
Madrid 28040 Spain

Hosp. Virgen de La Victoria
Málaga 29010 Spain

Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon 28223 Spain

Corporacio Sanitari Parc Tauli
Sabadell 08208 Spain

Hosp. Univ. Marques de Valdecilla
Santander 39008 Spain

Hosp. Univ. I Politecni La Fe
Valencia 46026 Spain

Södersjukhuset
Stockholm 11861 Sweden

Karolinska Universitetssjukhuset Solna
Stockholm 17176 Sweden

Akademiska Sjukhuset
Uppsala 751 85 Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung 807 Taiwan

China Medical University Hospital
Taichung 403 Taiwan

Taichung Veterans General Hospital
Taichung 40705 Taiwan

Tungs’ Taichung MetroHarbor Hospital
Taichung 435 Taiwan

Chi Mei Medical Center – Yong Kang
Tainan 710 Taiwan

National Taiwan University Hospital
Taipei 100 Taiwan

Taipei Veterans General Hospital
Taipei 11217 Taiwan

Chang Gung Memorial Hospital
Taoyuan 33305 Taiwan

Cukurova University, Faculty of Medicine
Adana 01330 Turkey

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara 06200 Turkey

Ankara Sehir Hastanesi
Ankara 6560 Turkey

Akdeniz University Medical Faculty
Antalya 07070 Turkey

Trakya University Medical Faculty
Edirne 22030 Turkey

Istanbul University Cerrahpasa Medical Faculty
Istanbul 34096 Turkey

Bakirkoy Training and Research Hospital
Istanbul 34147 Turkey

Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul 34722 Turkey

Izmır Medical Park Hospital
Izmir 35575 Turkey

Kocaeli University Medical Faculty
Kocaeli 41380 Turkey

Communal Nonprofit Enterprise ‘Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council’
Cherkasy 18009 Ukraine

Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I.
Dnipo 49005 Ukraine

Municipal Institution ‘Clinical Oncology Dispensary’ Under Dnipropetrovsk Regional Council
Dnipro 49100 Ukraine

Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro 49102 Ukraine

Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk 76008 Ukraine

Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
Kharkiv 61037 Ukraine

State Institution National Cancer Institute
Kyiv 03022 Ukraine

State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv 03115 Ukraine

Communal Noncommercial Enterprise of Lviv Regional Council ‘Lviv Regional Clinical Hospital’
Lviv 79031 Ukraine

Ukrainian Medical Stomatological Academy
Poltava 36024 Ukraine

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
Uzhgorod 88000 Ukraine

Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital
Zaporizhzhya 69600 Ukraine

Royal Blackburn Hospital
Blackburn BB2 3HH United Kingdom

Bristol Haematology and Oncology Centre
Bristol BS2 8ED United Kingdom

Royal Lancaster Infirmary
Lancaster LA1 4RP United Kingdom

UCL Cancer Institute
London WC1E 6DD United Kingdom

Royal Shrewsbury Hospital
Shrewsbury SY3 8XF United Kingdom

Torbay Hospital-Devon
Torquay TQ2 7AA United Kingdom

Royal Cornwall Hospitals NHS Trust – Royal Cornwall Hospital
Truro TR1 3LJ United Kingdom

New Cross Hospital
Wolverhampton WV10 0QP United Kingdom

View trial on ClinicalTrials.gov