Spots Global Cancer Trial Database for Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
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Trial Identification
Brief Title: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
Official Title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
Study ID: NCT02319837
Study Description
Brief Summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Alabama at Birmingham, IDS Pharmacy, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
Alaska Urological Institute dba Alaska Clinical Research Center, Anchorage, Alaska, United States
Urological Associates of Southern Arizona, PC, Tucson, Arizona, United States
Tower Hematology Oncology Medical Group, Beverly Hills, California, United States
Cedars-Senai OCC Pharmacy, Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
University of California, Irvine Medical Center, Orange, California, United States
Sutter Medical Group, Vascular & Varicose Vein Center, Roseville, California, United States
Sutter Medical Group, Roseville, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
University of California Davis Medical Center, Sacramento, California, United States
University of California, Davis, School of Medicine, Sacramento, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Foothills Urology, P.C., Golden, Colorado, United States
Eastern Connecticut Hematology Oncology Associates, Norwich, Connecticut, United States
Johns Hopkins Kimmel Cancer Center/ Sibley Infusion, Washington, District of Columbia, United States
Lakeland Regional Health Hollis Cancer Center, Lakeland, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Investigational Drug Service, Atlanta, Georgia, United States
The Emory Clinic, Atlanta, Georgia, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northwestern Medical Group, Chicago, Illinois, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
First Urology, PSC, Jeffersonville, Indiana, United States
The University of Kansas Hospital, Kansas City, Kansas, United States
Kansas City Urology Care, PA, Overland Park, Kansas, United States
The University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
The University of Kansas Cancer Center, Investigational Drug Services, Westwood, Kansas, United States
GU Research Network/Wichita Urology Group, Wichita, Kansas, United States
John Hopkins University Hospital, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
Comprehensive Urology - Macomb Office, Macomb, Michigan, United States
Comprehensive Urology - Royal Oak (Stephenson) office, Royal Oak, Michigan, United States
GU Research Network, LLC / Urology Cancer Center, Omaha, Nebraska, United States
VA Lahontan Valley Outpatient Clinic, Fallon, Nevada, United States
Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center Westchester, Harrison, New York, United States
Memorial Hospital, New York, New York, United States
Sidney Kimmel Center for Prostate and Urologic Cancers, New York, New York, United States
Premier Medical Group of the Hudson Valley PC, Poughkeepsie, New York, United States
Memorial Sloan Kettering Cancer Center Rockville Centre, Rockville Centre, New York, United States
Associated Medical Professionals of New York, PLLC, Syracuse, New York, United States
Memorial Sloan Kettering Cancer Center Nassau, Uniondale, New York, United States
Duke Investigational Chemotherapy Services, Durham, North Carolina, United States
Duke Nuclear Medicine, Durham, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Alliance Urology Specialists, PA, Greensboro, North Carolina, United States
TriState Urologic Services PSC Inc., dba The Urology Group, Cincinnati, Ohio, United States
Mercy Health Jewish Hospital, Cincinnati, Ohio, United States
Clinical Research Solutions, Middleburg Heights, Ohio, United States
Southwest Urology, Middleburg Heights, Ohio, United States
OU Medical Center Presbyterian Tower, Oklahoma City, Oklahoma, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Imaging Center, Eugene, Oregon, United States
Oregon Urology Institute, Springfield, Oregon, United States
Urologic Consultants of SE PA, Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists, Lancaster, Pennsylvania, United States
Lancaster Urology, Lancaster, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States
Jefferson Medical Oncology, Philadelphia, Pennsylvania, United States
Jefferson Urology Associates, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Bodine Buiding, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Medical Oncology, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery, Nashville, Tennessee, United States
Vanderbilt Unversity Medical Center, The Urology Clinic, Nashville, Tennessee, United States
Urology Clinics of North Texas, PLLC, Dallas, Texas, United States
Houston Metro Urology, Houston, Texas, United States
Urology San Antonio Research, San Antonio, Texas, United States
Henrico Doctor's Hospital, Henrico, Virginia, United States
Virginia Urology, Richmond, Virginia, United States
Urology of Virginia, PLLC., Virginia Beach, Virginia, United States
Genesis Cancer Care NSW, Gateshead, New South Wales, Australia
Lismore Base hospital, Lismore, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
Macquarie University, North Ryde, New South Wales, Australia
Genesis Cancer Care, North Sydney, New South Wales, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
GenesisCare North Shore, St Leonards, New South Wales, Australia
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Australian Clinical Trials Pty Ltd, Wahroonga, New South Wales, Australia
Sydney Adventist Hospital, Wahroonga, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Illawarra Cancer Care Centre, Wollongong, New South Wales, Australia
Crown Princess Mary Cancer Centre, Westmead, NEW, Australia
Icon Cancer Care Wesley, Auchenflower, Queensland, Australia
Icon Cancer Care Chermside, Chermside, Queensland, Australia
Icon Cancer Care South Brisbane, South Brisbane, Queensland, Australia
Icon Cancer Foundation, South Brisbane, Queensland, Australia
Icon Cancer Centre Southport, Southport, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Australian Urology Associates, Malvern, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Hospital Barmherzige Schwestern Linz, Linz, Upper Austria, Austria
Hospital Barmherzige Schwestern Linz, Department of Urology, Linz, , Austria
Ordensklinikum Linz GmbH, Linz, , Austria
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria, Salzburg, , Austria
Department of Radiology, University Hospital Salzburg, Austria, Salzburg, , Austria
Department of Urology,Paracelsus Medical University Salzburg, Salzburg, , Austria
AKH - Medizinische Universität Wien, Vienna, , Austria
Department of Internal Medicine I, Medical university Vienna, Vienna, , Austria
Hospital São Rafael S.A, Salvador, BA, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba, Parana, Brazil
CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo, Passo Fundo, RS, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda., Porto Alegre, RS, Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, RS, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, SP, Brazil
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP, Campinas, SP, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo Andre, SP, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda, Ijuí/RS, , Brazil
Prostate Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Vancouver Prostate Centre, Vancouver, British Columbia, Canada
Manitoba Prostate Centre CancerCare Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
The Male/Female Health and Research Centre, Royal Court Medical Centre, Barrie, Ontario, Canada
Kingston General Hospital, Kingston, Ontario, Canada
Centre for Applied Urological Research, Kingston, Ontario, Canada
Hotel Dieu Hospital, Kingston, Ontario, Canada
Urology Associates/ Urologic Medical Research, Kitchener, Ontario, Canada
London Health Sciences Centre - Victoria Hospital, London, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Urology South Shore Research, Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Ultra-Med Inc., Pointe-Claire, Quebec, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec, Quebec, , Canada
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO, Quebec, , Canada
Aarhus University Hospital, Arhus N, , Denmark
Rigshospitalet - Copenhagen University Hospital, Copenhagen N, , Denmark
Rigshospitalet - Copenhagen University Hospital, Copenhagen, , Denmark
Rigshospitalet, Dept of Radiology, Copenhagen, , Denmark
Odense University Hospital, Odense C, , Denmark
Vejle Sygehus, Vejle, , Denmark
Helsingin yliopistollinen keskussairaala, Helsinki, , Finland
Oulun yliopistollinen sairaala, Oulu, , Finland
Satakunnan Keskussairaala, Pori, , Finland
Seinaejoen Keskussairaala, Seinaejoki, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
ICO- site Paul Papin, Angers cedex 09, , France
Clinique Pasteur - Lanroze Service Pharmacie, Brest, , France
Clinique Pasteur - Lanroze, Brest, , France
CHD Vendée, LA ROCHE SUR YON cedex 9, , France
CHRU de Lille - Hopital Claude Huriez, Lille cedex, , France
ICM Val d'Aurelle, Montpellier Cedex 5, , France
CHU de Nantes - Hotel Dieu, Nantes, , France
Hopital Saint-Louis, Paris cedex 10, , France
Institut Mutualiste Montsouris, Paris Cedex 14, , France
CHP Saint-Gregoire, Saint-Gregoire, , France
ICO - site Rene Gauducheau, Saint-Herblain cedex, , France
Hia Begin, Saint-Mande, , France
Hopital Foch, Suresnes, , France
Institut Gustave Roussy, Villejuif cedex, , France
Institut Gustave Roussy, Villejuif, , France
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, , Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, , Italy
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, , Italy
UO di Oncologia,Ospedale Civile degli Infermi, Faenza RA, , Italy
UO di Radiologia, Ospedale Civile degli Infermi, Faenza RA, , Italy
UO di Oncologia, Ospedale Civile Umberto I, Lugo RA, , Italy
Uo di Radiologia, Ospedale Civile Umberto I, Lugo RA, , Italy
Laboratorio Farmaci Antiblastici, IRCCS Istituto, Meldola (FC), , Italy
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FC), , Italy
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST), Meldola (FC), , Italy
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A, Napoli, , Italy
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga, Orbassano (TO), , Italy
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga, Orbassano (TO), , Italy
Servizio di Farmacia, Ospedale Santa Maria delle Croci, Ravenna, , Italy
Servizio di Radiologia, Ospedale Santa Maria Delle Croci, Ravenna, , Italy
UO di Oncologia Medica, Ospedale Santa Maria delle Croci, Ravenna, , Italy
Farmacia Interna, Ospedale degli Infermi, Rimini, , Italy
UO Oncologia, Ospedale degli Infermi, Rimini, , Italy
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani, Roma, , Italy
U.O. di Oncologia Medica, Ospedale Santa Chiara, Trento, , Italy
U.O. Medicina Nucleare, Ospedale Santa Chiara, Trento, , Italy
U.O. Radiologia, Ospedale Santa Chiara, Trento, , Italy
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, Jeollanam-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Severance Hospital. Yonsei University Health System, Seoul, , 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
VU Medical Centrum, Department of Urology, Amsterdam, , Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Gelderse Vallei Ziekenhuis, Ede, , Netherlands
Catharina Ziekenhuis Eindhoven, Eindhoven, , Netherlands
University Medical Centrum Groningen, Department Urologie, Groningen, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Maastricht University Medical Center, Department of Urology, Maastricht, , Netherlands
Antonius Ziekenhuis, Sneek, , Netherlands
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o., Slupsk, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny, Slupsk, , Poland
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o, Torun, , Poland
Centrum Medyczne Melita Medical, Wroclaw, , Poland
EMC Instytut Medyczny Spolka Akcyjna, Wroclaw, , Poland
Fakultna nemocnica s poliklinikou F.D.Roosevelta, Banska Bystrica, , Slovakia
CUIMED, s.r.o., Urologicka ambulancia, Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav, a.s., Kosice, , Slovakia
Univerzitna nemocnica Martin, Martin, , Slovakia
UROEXAM, spol. s r.o., Nitra, , Slovakia
MILAB, Presov, , Slovakia
Fakultna nemocnica s poliklinikou Zilina, Zilina, , Slovakia
Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, Spain
Hospital Universitari Son Espases, Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, LA Coruna, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio, Barcelona, , Spain
Hospital Universitario Puerta del Mar, Cadiz, , Spain
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia, Girona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia., Madrid, , Spain
Centro Oncologico MD Anderson International Espana, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, , Spain
Complejo Hospitalario Universitario de Orense, Orense, , Spain
Corporacio Sanitaria Parc Tauli, Sabadell, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Sahlgrenska Universitetssjukhuset, Sahlgrenska, Goteborg, , Sweden
Skanes Universitetssjukhus, Malmo, , Sweden
Universitetssjukhuset Orebro, Orebro, , Sweden
Sodersjukhuset AB, Stockholm, , Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
Norrlands Universitetssjukhus, Umea, , Sweden
Norrlands Universitetssjukhus, Umea, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan, , Taiwan
Ross Hall Hospital, Glasgow, CITY OF Glasgow, United Kingdom
Royal Devon & Exeter Hospital, Wonford, Exeter, Devon, United Kingdom
Royal Free Hospital, London, Greater London, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Cancer Centre, Queen Elizabeth Hospital, Birmingham, WEST Midlands, United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Contact Details
Name: Pfizer Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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