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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04497844
Other study ID # CR108852
Secondary ID 2020-002209-2567
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 23, 2020
Est. completion date May 27, 2027

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 696
Est. completion date May 27, 2027
Est. primary completion date November 15, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Niraparib
Participants will receive Niraparib 200 mg once daily.
Abiraterone acetate (AA)
Participants will receive AA 1000 mg once daily.
Prednisone
Participants will receive prednisone 5 mg once daily.
Placebo for Niraparib
Participants will receive matching placebo for Niraparib once daily.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic Progression-free Survival (rPFS) rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria and Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Up to 47 months
Secondary Overall Survival (OS) OS is defined as the time from date of randomization to date of death from any cause. Up to 78 months
Secondary Time to Symptomatic Progression Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): a) the use of external beam radiation therapy for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; c) other cancer-related procedures; d) cancer-related morbid events; e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. Up to 47 months
Secondary Time to Subsequent Therapy Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer. Up to 47 months
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention. Up to 78 months
See also
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Completed NCT05149131 - A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer
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