Spots Global Cancer Trial Database for A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
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Trial Identification
Brief Title: A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
Official Title: A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort
Study ID: NCT04557059
Conditions
Study Description
Brief Summary: The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Urology Specialists, Tucson, Arizona, United States
Arkansas Urology, Little Rock, Arkansas, United States
Colorado Clinical Research, Lakewood, Colorado, United States
Urological Research Network, Hialeah, Florida, United States
First Urology, PSC, Jeffersonville, Indiana, United States
Michigan Institute of Urology, Troy, Michigan, United States
Associated Medical Professionals of Ny, Syracuse, New York, United States
The Urology Group, Cincinnati, Ohio, United States
Oregon Urology Institute, Springfield, Oregon, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Urology Austin, Austin, Texas, United States
Houston Metro Urology, Houston, Texas, United States
Spokane Urology, Spokane, Washington, United States
Bundaberg Hospital, Bundaberg, , Australia
Hervey Bay Hospital, Bundaberg, , Australia
Epworth Healthcare, East Melbourne, , Australia
St Vincent's Hospital - Melbourne, Fitzroy, , Australia
Genesis Care Hurstville, Hurstville, , Australia
Macquarie University Hospital, North Ryde, , Australia
Calvary Mater Newcastle, Waratah, , Australia
GenesisCare Wembley, Wembley, , Australia
Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria
Universitaetsklinikum Salzburg - Landeskrankenhaus, Salzburg, , Austria
Medizinische Universitat Wien, Wien, , Austria
A.Z. Sint Jan, Brugge, , Belgium
UZ Gent, Gent, , Belgium
Az Groeninge, Kortrijk, , Belgium
GZA Ziekenhuis, Wilrijk, , Belgium
Empresa Brasileira de Servicos Hospitalares - EBSERH - Hospital das Clinicas da UFMG, Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Associacao Hospitalar Moinhos de Vento, Porto Alegre, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro, , Brazil
Hospital Sao Rafael, Salvador, , Brazil
Hospital Alemao Oswaldo Cruz, Sao Paulo, , Brazil
Hospital Sao Camilo Unidade Vila Mariana, Sao Paulo, , Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo, , Brazil
Fakultni nemocnice Plzen, Urologicka klinika, Plzen, , Czechia
Urocentrum Praha, Praha 2, , Czechia
Urologicka klinika 1.LF UK a VFN, Praha 2, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus N., , Denmark
Rigshospitalet, Copenhagen N, , Denmark
Gentofte Herlev Hospital, Herlev, , Denmark
Helsinki University Hospital, Helsinki, , Finland
Oulu University Hospital, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Hospital, Turku, , Finland
Vaasa Central Hospital, Vaasa, , Finland
Vivantes Klinikum Am Urban, Berlin, , Germany
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer, Braunschweig, , Germany
Universitatsklinikum Carl Gustav Carcus Dresden, Dresden, , Germany
Universitatsklinikum Essen, Essen, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Klinikum rechts der Isar - der Technischen Universität München, Munchen, , Germany
Péterfy Sándor utcai Kórház, Budapest, , Hungary
Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Eszak Budai Szent Janos Centrumkorhaz, Budapest, , Hungary
Budapesti Uzsoki Utcai Korhaz, Budapest, , Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Radioterapia Oncologica, A.O.U. San'T Orsola, Bologna, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Ospedale San Raffaele, Milano, , Italy
Fondazione Policlinico Tor Vergata, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
King Hussein Cancer Center, Amman, , Jordan
St Georges Hospital university medical centre, Beirut, , Lebanon
American Universitty of Beirut Medical Center, Beirut, , Lebanon
Notre Dame De Secours, Jbeil, , Lebanon
Centre Hospitalier du Nord, Zgharta, , Lebanon
Consultorio de Especialidad en Urologia Privado, Durango, , Mexico
Hospital Aranda de la Parra S A de C V, Leon, , Mexico
Avix Investigacion Clinica S C, Monterrey, , Mexico
Oncologia Integral Satelite, Naucalpan, , Mexico
Centro de Investigacion Clinica de Oaxaca, Oaxaca de Juárez, , Mexico
Oncocenter, Puebla, , Mexico
Centro de Estudio Clínicos de Querétaro S.C., Queretaro, , Mexico
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
NU-MED Grupa S.A Centrum Radioterapii i Onkologii, Elblag, , Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Szpitale Pomorskie Sp z o o, Gdynia, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce, , Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Koszalin, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi, Lodz, , Poland
Radomskie Centrum Onkologii, Radom, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
IPO Lisboa, Lisboa, , Portugal
Hospital CUF Tejo, Lisboa, , Portugal
Fund. Champalimaud, Lisboa, , Portugal
Centro Hospitalar Lisboa Ocidental - Hospital São Fracisco Xavier, Lisboa, , Portugal
Hospital da Luz, Lisboa, , Portugal
Chln - Hosp. Santa Maria, Lisboa, , Portugal
Centro Hospitalar Universitario do Porto, EPE, Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E, Santa Maria da Feira, , Portugal
SHI Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
City Clinical Hospital #57, Moscow, , Russian Federation
I.M. Sechenov First Moscow State Medical University, Moscow, , Russian Federation
Hertzen Oncology Research Institute, Moscow, , Russian Federation
SPb SBIH 'City Clinical Oncological Dispensary', Saint Petersburg, , Russian Federation
Leningrad Regional Oncology Dispensary, Saint-Petersburg, , Russian Federation
Multifunctional clinical medical center 'Medical city', Tyumen, , Russian Federation
CUIMED - urologická ambulancia, Bratislava, , Slovakia
Východoslovenský Onkologický Ústav, Košice, , Slovakia
Univerzitná nemocnica Martin, Martin, , Slovakia
Uroexam s.r.o., Nitra, , Slovakia
Urologicka ambulancia e.cho Poprad, s.r.o, Poprad, , Slovakia
MILAB s.r.o., Prešov, , Slovakia
Privátna urologická ambulancia, Trencin, , Slovakia
Hospital Universitario Puerto Del Mar, Cadiz, , Spain
Hosp. Arquitecto Marcide, Ferrol, , Spain
Hosp. de Jerez de La Frontera, Jerez de la Frontera, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. de La Paz, Madrid, , Spain
Hosp. Virgen de La Victoria, Málaga, , Spain
Complejo Hosp. de Navarra, Navarra, , Spain
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Hosp. Univ. I Politecni La Fe, Valencia, , Spain
Hosp. Clinico Univ. Lozano Blesa, Zaragoza, , Spain
Urologiska Mottagningen, Malmö, , Sweden
Prostatacancercentrum, Stockholm, , Sweden
Södersjukhuset, Stockholm, , Sweden
Adana Baskent Yuregir Hospital, Adana, , Turkey
Hacettepe University Medical Faculty, Ankara, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Ankara University Medical Faculty, Ankara, , Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Bakirkoy Training and Research Hospital, Istanbul, , Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi, Istanbul, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Izmir, , Turkey
Sakarya Üniversitesi Tıp Fakültesi Hastanesi, Sakarya, , Turkey
Contact Details
Name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
Affiliation: Janssen Pharmaceutica N.V., Belgium
Role: STUDY_DIRECTOR
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