Spots Global Cancer Trial Database for A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
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Trial Identification
Brief Title: A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Study ID: NCT03767244
Conditions
Study Description
Brief Summary: The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
UC San Diego Moores Cancer Center, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
University of California Los Angeles, Los Angeles, California, United States
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center, Orange, California, United States
UC Davis Medical Center, Sacramento, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Colorado Clinical Research, Lakewood, Colorado, United States
Stamford Hospital, Stamford, Connecticut, United States
Urology Specialists LLC, Hialeah, Florida, United States
Mayo Clinic - Division Of Hematology/oncology, Jacksonville, Florida, United States
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group, Miami, Florida, United States
Florida Hospital, Orlando, Florida, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Ochsner LSU Health Shreveport - Regional Urology, Shreveport, Louisiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States
Michigan Institute of Urology, PC, Troy, Michigan, United States
Saint Louis University, Saint Louis, Missouri, United States
Urology Cancer Center, PC, Omaha, Nebraska, United States
Albany Medical College, Albany, New York, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates, Cheektowaga, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University School of Medicine, Durham, North Carolina, United States
Medication Management LLC, Greensboro, North Carolina, United States
Carolina Urology Partners, PLLC, Huntersville, North Carolina, United States
Cleveland VA Medical Center, Cleveland, Ohio, United States
Oklahoma City VAMC, Oklahoma City, Oklahoma, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Omega Medical Research, Warwick, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, United States
Greenville Health, Greenville, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
VA North Texas Health Care System, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Urology, Richmond, Virginia, United States
Urology of Virginia, PLCC, Virginia Beach, Virginia, United States
CAMC Memorial Hospital, Charleston Area Medical Center Physicians, Charleston, West Virginia, United States
Hospital Aleman, Caba, , Argentina
Hospital Italiano de Buenos Aires, Ciudad Autonoma de, , Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Cordoba, , Argentina
Centro Urologico Profesor Bengio, Cordoba, , Argentina
Uroclinica, Mendoza, , Argentina
Clinica Mayo de UMCB, San Miguel de Tucuman, , Argentina
Epworth Eastern Hospital, Box Hill, , Australia
St. Vincent's Hospital Sydney, Darlinghurst, , Australia
Austin Health, Heidelberg, , Australia
Australian Urology Associates Pty Ltd, Malvern, , Australia
Royal Melbourne Hospital, Parkville, , Australia
Northern Cancer Institute, St Leonards, , Australia
Australian Clinical Trials - SAN Clinic, Wahroonga, , Australia
Westmead Hospital, Westmead, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge, Goiania, , Brazil
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda, Ijui, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, , Brazil
Associacao Umane, Sao Paulo, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
Instituto Do Cancer Brasil, Tres Lagoas, , Brazil
Prostate Cancer Centre, Calgary, Alberta, Canada
Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver, British Columbia, Canada
Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
London Health Sciences Center, London, Ontario, Canada
Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
University Health Network UHN Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal, Montreal, Quebec, Canada
CHU de Quebec Universite Laval Hopital de l Enfant Jesus, Quebec, , Canada
Fakultni nemocnice Hradec Kralove, Hradec Králove, , Czechia
Krajská nemocnice Liberec, Liberec, , Czechia
Uromedical Center s.r.o., Olomouc, , Czechia
Fakultni nemocnice Plzen, Urologicka klinika, Plzen, , Czechia
Thomayerova nemocnice, Praha 4, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha, , Czechia
CHU d'Angers, Angers, , France
CHRU Besancon Hopital Jean Minjoz, Besançon Cedex, , France
Hopital Pellegrin CHU Bordeaux, Bordeaux N/a, , France
APHP - Hopital Henri Mondor, Créteil, , France
Hopital Edouard Herriot - CHU Lyon, Lyon cedex 03, , France
CHU de Nantes hotel Dieu, Nantes, , France
Institut Mutualiste Montsouris, Paris, , France
Clinique de la Croix du Sud, Quint-Fonsegrives, , France
Chu Rennes Hopital Pontchaillou, Rennes Cedex, , France
CHU de Toulouse - Hôpital Rangueil, Toulouse Cedex 9, , France
CHRU Tours Hopital Bretonneau, Tours, , France
Universitaetsklinikum der RWTH Aachen, Aachen, , Germany
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer, Braunschweig, , Germany
Universitatsklinikum Essen, Essen, , Germany
Universitatsklinikum Frankfurt, Frankfurt am Main, , Germany
Prostata zentrum Nordwest, Gronau, , Germany
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie, Hamburg, , Germany
Universitätsklinikum des Saarlandes, Homburg/Saar, , Germany
Universitaetsklinikum Koelnt, Koeln, , Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lubeck, , Germany
Praxis Dr. med. Ralf Eckert, Lutherstadt Eisleben, , Germany
Klinikum St. Elisabeth Straubing GmbH, Straubing, , Germany
Kliniken Nordoberpfalz, Klinik für Urologie, Weiden/Opf, , Germany
Praxisgemeinschaft f. Onkologie u. Urologie - Germany, Wilhelmshaven, , Germany
Asaf Harofe Medical Center, Beer Yaakov, , Israel
Rambam Health Care Campus, Haifa, , Israel
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC), Kfar Saba, , Israel
Rabin Medical Center, Petach Tikva, , Israel
The Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Policlinico Abano Terme, Abano Terme, , Italy
Generale Regionale F. Miulli, Acquaviva delle Fonti, , Italy
Ospedale di Bassano del Grappa, Bassano del Grappa, , Italy
ASST Spedali Civili Brescia, Brescia, , Italy
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti, Chieti, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico, MIlano, , Italy
Ospedale San Raffaele, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia, Modena, , Italy
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara, Novara, , Italy
Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, , Italy
Universita Campus Bio-Medico di Roma, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
Ospedale Molinette, AO Città della Salute e della Scienza di, Torino, , Italy
UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento, Verona, , Italy
Akita University Hospital, Akita, , Japan
Chiba University Hospital, Chiba, , Japan
Chiba Cancer Center, Chuo-ku, Chiba-City,, , Japan
Hakodate Goryoukaku Hospital, Hakodate, , Japan
Hirosaki University Hospital, Hirosaki, , Japan
Kanazawa University Hospital, Kanazawa, , Japan
Kobe City Medical Center General Hospital, Kobe, , Japan
Dokkyo Medical University Saitama Medical Center, Koshigaya, , Japan
Kurume University Hospital, Kurume, , Japan
Kyoto University Hospital, Kyoto, , Japan
National Hospital Organizaiton Shikoku Cancer Center, Matsuyama, , Japan
Kitasato University Hospital, Minami-Ku, Sagamihara-Shi, , Japan
University of Miyazaki Hospital, Miyazaki, , Japan
Nagano Municipal Hospital, Nagano, , Japan
Kindai University Hospital, Osaka Sayama shi, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Toho University Sakura Medical Center, Sakura, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Iwate Medical University Hospital, Shiwa-gun, , Japan
Juntendo University Hospital, Tokyo, , Japan
Nippon Medical School Hospital, Tokyo, , Japan
Yamaguchi University Hospital, Ube, , Japan
Yokohama City University Medical Center, Yokohama, , Japan
Chonnam National University Hospital, Gwangju, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
NKI-AVL, Amsterdam, Amsterdam, , Netherlands
Catharinaziekenhuis, Eindhoven, , Netherlands
St. Antonius Ziekenhuis (St. Antonius Hospital), Nieuwegein, , Netherlands
Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy, Bydgoszcz, , Poland
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza, Bydgoszcz, , Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Koszalin, , Poland
Pratia MCM Krakow, Krakow, , Poland
City Clinic Sp. z o.o., Warszawa, , Poland
Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia, Wrocław, , Poland
Altai Regional Oncology Dispensary, Barnaul, , Russian Federation
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine, Chelyabinsk, , Russian Federation
Moscow City Clinical Hospital # 62, Moscow, , Russian Federation
Hertzen Oncology Research Institute, Moscow, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
Medical-sanitary unit 'Neftyanik', Tyumen, , Russian Federation
Vologda Regional Oncological Dispensary, Vologda, , Russian Federation
Hosp. Univ. A Coruna, A Coruna, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Puerta Del Mar, Cadiz, , Spain
Hosp. Gral. Univ. de Castellon, Castellón, , Spain
Hosp. de Jerez de La Frontera, Jerez de la Frontera, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. La Paz, Madrid, , Spain
Fund. Hosp. de Manacor, Manacor, , Spain
Hosp. Virgen de La Victoria, Málaga, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Inst. Valenciano de Oncologia, Valencia, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Tungs' Taichung MetroHarbor Hospital, Taichung, , Taiwan
Chi Mei Medical Center Yong Kang, Tainan, , Taiwan
National Taiwan University Hospital., Taipei, , Taiwan
Southmead Hospital, Bristol, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Ninewells Hospital, Dundee, , United Kingdom
The Royal Marsden NHS Trust, London, , United Kingdom
University College London, London, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital, Preston, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
MidYorkshire NHS Trust, Wakefield, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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