Clinical trial NCT04497844: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Castration-sensitive Prostate Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 696
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

Detailed description: Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AAP) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib in combination with AAP has been approved for the treatment of BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC). Niraparib is an investigational agent in the Metastatic Castration-Sensitive Prostate Cancer (mCSPC) population. Whether the addition of niraparib to the AAP standard of care may improve initial disease control and long-term outcomes compared with AAP alone in a biomarker selected mCSPC population is being evaluated on this trial. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.

Eligibility criteria: Inclusion criteria:

* Pathological diagnosis of prostate adenocarcinoma
* Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
* Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
* Androgen deprivation therapy (either medical or surgical castration) must have been started \>=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
* Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms). Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation. Radiation must be completed prior to randomization (b) Up to a maximum of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization

Exclusion criteria:

* Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP inhibitor)
* History of adrenal dysfunction
* Long-term use of systemically administered corticosteroids (greater than \[\>\] 5 milligrams \[mg\] of prednisone or the equivalent) during the study is not allowed. Short-term use (\<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
* History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)

Primary outcomes:
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: Up to 47 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 78 months
measure: Time to Symptomatic Progression
timeFrame: Up to 47 months
measure: Time to Subsequent Therapy
timeFrame: Up to 47 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 78 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, P.C.
state: Arizona
city: Los Angeles
country: United States
facility: Greater Los Angeles VA Healthcare System
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: San Francisco
country: United States
facility: University of San Francisco California
state: California
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: AdventHealth Medical Group Urology of Denver
state: Colorado
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Assoc.
state: Connecticut
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Greenwood
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Saint Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center
state: Missouri
city: Omaha
country: United States
facility: GU Research Network
state: Nebraska
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Manhattan VAMC
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson Veterans Affairs Medical Center
state: South Carolina
city: Seneca
country: United States
facility: Prisma Health
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Northeast
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: New Braunfels
country: United States
facility: Texas Oncology P A
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University - Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Healthcare System
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Buenos Aires
country: Argentina
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: Buenos Aires
country: Argentina
facility: Centro Oncológico Korben
city: C.a.b.a.
country: Argentina
facility: Hospital Militar Cosme Argerich
city: Caba
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas
city: Caba
country: Argentina
facility: CIPREC Arenales
city: Ciudad Automoma Buenos Aires
country: Argentina
facility: Centro de Urologia (CDU)
city: Ciudad Autonoma de
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Cordoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Cordoba
country: Argentina
facility: Instituto Médico de Río Cuarto
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de Comunidad
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: San Salvador De Jujuy
country: Argentina
facility: ARS Médica
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Darlinghurst
country: Australia
facility: St Vincent s Hospital Sydney
city: Herston
country: Australia
facility: Cancer Care Services Clinical Research Unit
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Kurralta Park
country: Australia
facility: Icon Cancer Centre Kurralta Park
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: North Ryde
country: Australia
facility: Macquarie University Hospital
city: South Brisbane
country: Australia
facility: ICON Cancer Care
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
city: Bobruisk
country: Belarus
facility: Bobruisk Interregional Oncology Dispensary
city: Brest
country: Belarus
facility: Brest Regional Oncology Dispensary
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Oncology Dispensary
city: Grodno
country: Belarus
facility: Grodno University Hospital
city: Lesnoy
country: Belarus
facility: N N Alexandrov National Cancer Centre of Belarus
city: Minsk
country: Belarus
facility: Minsk city Clinical Oncological Dispensary
city: Mogilev
country: Belarus
facility: Mogilev Regional Oncology Dispensary
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncology Dispensary
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Charleroi
country: Belgium
facility: Grand Hopital De Charleroi Site Les Viviers
city: Haine-St-Paul
country: Belgium
facility: Jolimont
city: Liege
country: Belgium
facility: CHC MontLegia
city: Namur
country: Belgium
facility: CHU UCL Namur - Site Sainte Elisabeth
city: Ottignies
country: Belgium
facility: Clinique St Pierre
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Belo Horizonte
country: Brazil
facility: PERSONAL Oncologia de Precisao e Personalizada
city: Curitiba
country: Brazil
facility: CIONC Centro Integrado de Oncologia de Curitiba
city: Florianopolis
country: Brazil
facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
city: Fortaleza
country: Brazil
facility: Pronutrir
city: Goiania
country: Brazil
facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
city: Ipatinga
country: Brazil
facility: Fundacao Sao Francisco Xavier
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Pelotas
country: Brazil
facility: UPCO Unidade de Pesquisa Clinica em Oncologia
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Recife
country: Brazil
facility: MultiHemo Servicos Medicos S.A
city: Rio de Janeiro
country: Brazil
facility: Ministerio da Saude Instituto Nacional do Cancer
city: Rio de Janeiro
country: Brazil
facility: Universidade do Estado do Rio de Janeiro - UERJ
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santo Andre
country: Brazil
facility: Fundacao do ABC Centro Universitario FMABC
city: Sao Paulo
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
city: Sorocaba
country: Brazil
facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
city: São Paulo
country: Brazil
facility: Instituto do Cancer Arnaldo Vieira de Carvalho
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
city: Uberlândia
country: Brazil
facility: Centro Oncológico do Triângulo
city: Burgas
country: Bulgaria
facility: MHAT Deva Maria
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: Multifunctional Hospital for Active Treatment for Women Health Nadezhda
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology
city: Sofia
country: Bulgaria
facility: UMHAT Sofia Med
city: Vratsa
country: Bulgaria
facility: Comprehensive Cancer Center
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency BCCA Vancouver Centre
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency Vancouver Island Centre
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Institute of Urology
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre, Kingston General Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University - Jewish General Hospital
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Chengdu
country: China
facility: Western Theater General Hospital of the Chinese People's Liberation Army
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Chongqing
country: China
facility: Southwest Hospital, The Third Military Medical University
city: GuangZhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanjing
country: China
facility: Jiangsu Province Cancer Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
city: Shanghai
country: China
facility: The Fifth People's Hospital of Shanghai, Fudan University
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: SuZhou
country: China
facility: Second Affiliated Hospital of Soochow University
city: Suzhou
country: China
facility: The First Affliated Hospital of Soochow University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
city: XI An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove, Urologicka klinika
city: Liberec
country: Czechia
facility: Krajská nemocnice Liberec
city: Olomouc
country: Czechia
facility: Uromedical Center s.r.o.
city: Praha 2
country: Czechia
facility: Urologicka klinika 1 LF UK a VFN
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Naestved
country: Denmark
facility: Næstved Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Angers Cedex 9
country: France
facility: Institut de Cancerologie de l Ouest ICO
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: CHRU De Besancon
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier Val d'Aurelle
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Poitiers Cedex
country: France
facility: CHU De Poitiers
city: Quimper
country: France
facility: Centre Hopitalier Inter-Communal De Cornouaille
city: Saint Mande
country: France
facility: HIA Begin
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de Loire
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Suresnes
country: France
facility: Hopital Foch
city: Tours
country: France
facility: CHRU de Tours
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Koeln
country: Germany
facility: Universitaetsklinikum Koelnt
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: München
country: Germany
facility: Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie Drs. Feyerabend
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Miskolc
country: Hungary
facility: Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Tatabanya
country: Hungary
facility: Szent Borbala Hospital Tatabanya
city: Afula
country: Israel
facility: Haemek Medical Center - Afula
city: Beer-Sheva
country: Israel
facility: Soroka Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hospital
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Center Tel Hashomer
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Arezzo
country: Italy
facility: Ospedale S. Donato - Asl 8 Arezzo
city: Candiolo
country: Italy
facility: Divisione di Oncologia - Istituto per la ricerca e cura del cancro
city: Cremona
country: Italy
facility: Istituti Ospitalieri di Cremona, AO di Cremona
city: Lecce
country: Italy
facility: Azienda Ospedaliera ''Vito Fazzi''
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: European Institute of Oncology
city: Napoli
country: Italy
facility: Fondazione G Pascale Istituto Nazionale Tumori IRCCS
city: Orbassano
country: Italy
facility: Aou San Luigi Gonzaga
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Iov Irccs Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Pozzuoli
country: Italy
facility: ASL Napoli 2 Nord-SM delle Grazie Hospital
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza IRCCS
city: Trento
country: Italy
facility: Ospedale S. Chiara
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara Clinical Research Center
city: Ciudad de Mexico
country: Mexico
facility: Centro de Investigación Clínica Gramel S.C.
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Leon
country: Mexico
facility: Consultorio Privado
city: Monterrey
country: Mexico
facility: Avix Investigacion Clinica S C
city: Monterrey
country: Mexico
facility: i Can Oncology Center
city: Naucalpan
country: Mexico
facility: Oncologia Integral Satelite
city: Oaxaca
country: Mexico
facility: Consultorio de Oncología Médica
city: Zapopan
country: Mexico
facility: Consultorio Privado
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelminaziekenhuis
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Canterbury Urology Research Trust
city: Dunedin Central
country: New Zealand
facility: Dunedin Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Bydgoszcz
country: Poland
facility: IN VIVO Sp. z o.o
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp z o o
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED Roman Karaszewski
city: Krakow
country: Poland
facility: Klinika MedTrials
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Lublin
country: Poland
facility: Medisport
city: Siedlce
country: Poland
facility: Urologica Praktyka Lekarska Adam Marcheluk
city: Warszawa
country: Poland
facility: Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
city: Wroclaw
country: Poland
facility: Specjalistyczna przychodnia lekarska POLIMED
city: Almada
country: Portugal
facility: Uls Almada Seixal - Hosp. Garcia de Orta
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
city: Lisboa
country: Portugal
facility: Fund. Champalimaud
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Santa Maria
city: Hato Rey
country: Puerto Rico
facility: Puerto Rico Medical Research Center
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 62
city: Moscow
country: Russian Federation
facility: Hertzen Oncology Research Institute
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsky District Medical Centre
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: LLC Novaya Clinica
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Interdistrict Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Private Medical Institution Euromedservice
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Saransk
country: Russian Federation
facility: Republican Oncology Dispensary
city: Tomsk
country: Russian Federation
facility: Tomsk Cancer Research Institute
city: Tyumen
country: Russian Federation
facility: Multifunctional clinical medical center 'Medical city'
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Cape Town
country: South Africa
facility: CancerCare Rondebosch
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
city: Vosloorus
country: South Africa
facility: East Rand Urology Research Unit
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Castellon
country: Spain
facility: Hosp. Gral. Univ. de Castellon
city: Girona
country: Spain
facility: Institut Català D'Oncologia Girona
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp. Univ. Hm Monteprincipe
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Göteborg
country: Sweden
facility: Salgrenska University hospital
city: Malmö
country: Sweden
facility: Urologiska Mottagningen
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Tungs' Taichung MetroHarbor Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital.
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Adana Baskent Yuregir Hospital
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Gazi University Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Bursa
country: Turkey
facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
city: Istanbul
country: Turkey
facility: Bakirkoy Training and Research Hospital
city: Istanbul
country: Turkey
facility: T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Izmir
country: Turkey
facility: Izmir Medical Point Hospital
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
city: Samsun
country: Turkey
facility: Medical Park Samsun Hastanesi
city: Cherkasy
country: Ukraine
facility: CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
city: Chernivtsi
country: Ukraine
facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
city: Dnipro
country: Ukraine
facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
city: Dnipro
country: Ukraine
facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kamianske
country: Ukraine
facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
city: Khakhiv
country: Ukraine
facility: Municipal non-profit enterprise 'Regional Center of Oncology'
city: Kharkiv
country: Ukraine
facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
city: Kherson
country: Ukraine
facility: Kherson Regional Oncological Dispensary
city: Kyiv
country: Ukraine
facility: Nonprofit Organization National Cancer Institute
city: Kyiv
country: Ukraine
facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
city: Kyiv
country: Ukraine
facility: Kyiv Regional Oncological Dispensary
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
city: Vinnitsa
country: Ukraine
facility: Podilskiy Regional Center of Oncology
city: Zhytomyr
country: Ukraine
facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Great Maze Pond
country: United Kingdom
facility: Guy's Hospital
city: Grimsby
country: United Kingdom
facility: Prince Of Wales Hospital
city: Hillingdon
country: United Kingdom
facility: Marie Curie Research Wing - Mount Vernon Hospital
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHSFT
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: