Spots Global Cancer Trial Database for A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
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Trial Identification
Brief Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Official Title: PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
Study ID: NCT01212991
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
Detailed Description:
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, Birmingham, Alabama, United States
The University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
The University of Arizona Cancer Certer-North Campus, Tucson, Arizona, United States
Cancer Center Oncology Medical Group, La Mesa, California, United States
Keck Hospital of USC, Los Angeles, California, United States
LAC&USC Medical Center, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services, Los Angeles, California, United States
UCLA Clark Urology Clinic, Los Angeles, California, United States
North County Oncology Medical Clinic, Inc, Oceanside, California, United States
UC Davis Medical Center, Sacramento, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Medical Oncology Associates-SD, San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy, San Diego, California, United States
Sharp Rees-Stealy, San Diego, California, United States
Stanford University Medical Center, Stanford, California, United States
Anschutz Cancer Center Pavilion Pharmacy, Aurora, Colorado, United States
University of Colorado Hospital, Anschutz Cancer Pavilion, Aurora, Colorado, United States
Lynn Cancer Institute Center for Hematology Oncology, Boca Raton, Florida, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Jewish Hospital & St. Mary's Healthcare, Inc., Louisville, Kentucky, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaoness Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Barnes-Jewish West County Hospital, Creve Coeur, Missouri, United States
BJH Pharmacy, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Barnes-Jewish St. Peters Hospital, Saint Peters, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
The Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Cancer Centers of North Carolina, Cary, North Carolina, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Levine Cancer Institute - Main, Charlotte, North Carolina, United States
Levine Cancer Institute - Southpark, Charlotte, North Carolina, United States
Levine Cancer Institute - University, Charlotte, North Carolina, United States
Levine Cancer Institute - Ballantyne, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Investigational Chemotherapy Services, Durham, North Carolina, United States
Cancer Centers of North Carolina, Raleigh, North Carolina, United States
Portland VA Medical Center Laboratory, Portland, Oregon, United States
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
UPMC Presbyterian, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Hematology / Oncology MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Medical University of South Carolina - Urology Services, Charleston, South Carolina, United States
MUSC Department of Radiology, Charleston, South Carolina, United States
MUSC Urology Ambulatory Care, Charleston, South Carolina, United States
MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor, Mount Pleasant, South Carolina, United States
MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor, Mount Pleasant, South Carolina, United States
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States
Virginia Oncology Associates, Hampton, Virginia, United States
Virginia Oncology Associates, Newport News, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Virginia Oncology Associates, Virginia Beach, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
St George Private Hospital, Kogarah, New South Wales, Australia
Lismore Base Hospital, Lismore Cancer Care and Haematology Unit, Lismore, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
North Coast Cancer Institute, Port Macquarie, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, Department of Medical Oncology, St Leonards, New South Wales, Australia
Sydney Adventist Hospital, Sydney, New South Wales, Australia
Australian Clinical Trials Pty Ltd, Wahroonga, New South Wales, Australia
SAN Pathology, Wahroonga, New South Wales, Australia
SAN Radiology, Wahroonga, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Heart Care Partners, Auchenflower, Queensland, Australia
Icon Cancer Care Wesley, Auchenflower, Queensland, Australia
River City Pharmacy, Auchenflower, Queensland, Australia
Icon Cancer Care Chermside, Chermside, Queensland, Australia
University of Queensland Centre for Clinical Research (UQCCR), Herston, Queensland, Australia
Nuclear Medicine and Imaging Department, Herston, Queensland, Australia
Icon Cancer Care South Brisbane, South Brisbane, Queensland, Australia
Icon Cancer Foundation, South Brisbane, Queensland, Australia
Mater Private Cardiology, South Brisbane, Queensland, Australia
Adelaide Cancer Centre, Kurralta Park, South Australia, Australia
APHS Pharmacy, Kurralta Park, South Australia, Australia
Ashford Cancer Centre Research, Kurralta park, South Australia, Australia
Cancer Care SA Pty Ltd, Kurralta Park, South Australia, Australia
Bendigo Health, Bendigo Hospital, Bendigo, Victoria, Australia
Bendigo Health Medical Imaging, Bendigo, Victoria, Australia
Eastern Health, Box Hill, Victoria, Australia
MIA Box Hill Radiology, Box Hill, Victoria, Australia
Oncology Eastern Clinical Research Unit (ECRU), Box Hill, Victoria, Australia
Pharmacy Department, Box Hill, Victoria, Australia
Cabrini Hospital Brighton, Brighton, Victoria, Australia
Monash Health Translation Precinct, Clayton, Victoria, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Barwon Health, Geelong Hospital, Geelong, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Cabrini Hospital Malvern, Malvern,, Victoria, Australia
Cabrini Radiology, Malvern, Victoria, Australia
MDI Chemer, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Krankenhaus der Barmherzigen Schwestern Linz, Linz, , Austria
Ordination Dr. Fink, Salzburg, , Austria
Salzburger Universitatsklinikum, Salzburg, , Austria
Medizinische Universitaet Wien, Wien, , Austria
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
AZ Sint-Lucas, Ghent, , Belgium
Jessaziekenhuis, Hasselt, , Belgium
AZ Groeninge, Campus KL, Kortrijk, , Belgium
UZ Leuven - University Hospital Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege-Urologie, Liege, , Belgium
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre, Calgary, Alberta, Canada
Tom Baker Cancer Centre - Holy Cross Site, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior, Kelowna, British Columbia, Canada
Vancouver Prostate Centre, Vancouver, British Columbia, Canada
Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging, Victoria, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre, Victoria, British Columbia, Canada
Manitoba Prostate Centre, Winnipeg, Manitoba, Canada
QEII Health Sciences Centre, Nova Scotia Cancer Centre., Halifax, Nova Scotia, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
London RegCancer Program, London Health Sciences Centre, London, Ontario, Canada
The Ottawa Hospital Cancer Centre, General Campus, Ottawa, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec, Quebec, , Canada
Centre de recherche clinique el evaluative en oncologie (CRCEO), Quebec, , Canada
Aalborg Hospital Nord, Aalborg, , Denmark
Aarhus Universitetshospital, Aarhus N, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Frederiksberg Hospital, Frederiksberg, , Denmark
Herlev Hospital, Herlev, , Denmark
Roskilde Sygehus, Roskilde, , Denmark
Docrates Clinic, Helsinki, , Finland
Helsinki University Central Hospital, Helsinki, , Finland
Oulu University Hospital, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Hopital Civil, Strasbourg, Alsace, France
Centre Eugene Marquis-Service d'Oncologie Medicale, Rennes cedex, Bretagne, France
Institut Bergonie, Bordeaux, Nouvelle Aquitaine, France
ICO Paul Papin, Angers, , France
Clinique Rhone Durance, Avignon, , France
Institut Bergonie, Bordeaux, , France
CHD Vendee, La Roche sur Yon Cedex, , France
Centre Jean Bernard - Clinique Victor Hugo, Le Mans, , France
Centre Leon Berard, Lyon, , France
Hopital Europeen Georges Pompidou, Paris Cedex 15, , France
Institut Curie, Paris, , France
Groupe Hospitalier La Pitie Salpetriere, Paris, , France
Centre de Recherche Clinique, Saint Herblain Cedex, , France
HIA Begin, Service de Medecine Interne et Oncologie, Saint-Mande, , France
Institut de Cancerologie Lucien Neuwirth, Saint-Priest en Jarez, , France
Clinique Pasteur, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin, , Germany
Staedtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der, Dresden, , Germany
Martini-Klinik am UKE Gmbh, Hamburg, , Germany
Urologikum Hamburg, Hamburg, , Germany
Universitaetsklinikum Heidelberg, Klinik Fuer Urologie, Heidelberg, , Germany
Universitaetsklinikum des Saarlandes, Homburg/Saar, , Germany
Universitaetsklinikum Mannheim, Klinik fuer Urologie, Mannheim, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie, Tuebingen, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden In Der Oberpfalz, , Germany
Soroka University Medical Center, Beer Sheva, , Israel
Assaf Harofe Medical Center, Beer Yaakov, , Israel
Bnai Zion Medical Center, Haifa, , Israel
Rabin Medical Center, Petach Tikva, , Israel
The Chaim Sheba Medical Center, Ramat Gan, , Israel
Azienda Socio Sanitaria Territoriale di Cremona, Cremona, CR, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, FC, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, TO, Italy
Azienda USL8-Presidio Ospedaliero S.Donato, Arezzo, , Italy
Ospedale G.B. Morgagni, Forli, , Italy
Azienda Ospedaliera San. Camillo Forlanini, Rome, , Italy
Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan
Yokohama City University Hospital, Yokohama-shi, Kanagawa-ken, Japan
Tohoku University Hospital, Sendai-Shi, Miyagi, Japan
Nagasaki University Hospital, Nagasaki-shi, Nagasaki, Japan
Kindai University Hospital, Osaka-sayama, Osaka, Japan
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan
Osaka University Hospital, Suita-shi, Osaka, Japan
Tokushima University Hospital, Tokushima-shi, Tokushima, Japan
Nippon Medical School Hospital, Bunkyo-ku, Tokyo, Japan
Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan
Cancer Institute Hospital, Koutou-ku, Tokyo, Japan
Kyorin University Hospital, Mitaka-shi, Tokyo, Japan
Showa University Hospital, Shinagawa-ku, Tokyo, Japan
Keio University Hospital, Shinjyuku-ku, Tokyo, Japan
Yamaguchi University Hospital, Ube-shi, Yamaguchi, Japan
Chiba Cancer Center, Chiba, , Japan
Kyoto University Hospital, Kyoto, , Japan
Niigata University Medical and Dental Hospital, Niigata, , Japan
Osaka City University Hospital, Osaka, , Japan
Jikei University Hospital, Tokyo, , Japan
Yamagata Prefectural Central Hospital, Yamagata, , Japan
National Cancer Center, Goyang, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of
Samsung Medical Center, Gangnam-gu, Seoul, Korea, Republic of
Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Klaipeda University Hospital, Klaipeda, , Lithuania
Division of Oncourology, National Cancer Institute, Vilnius, , Lithuania
Vrije Universiteit Medical Center, Department of Medical Oncology, Amsterdam, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
University Medical Center Groningen, Department of Urology, Groningen, , Netherlands
UMC St. Radboud, Nijmegen, , Netherlands
EMC Instytut Medyczny S.A., Wroclaw, Dolnoslaskie, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi, Lodz, Lodzkie, Poland
Apteka Szpitalna, Gdansk, Pomorskie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Niepubliczny Zaklad Opieki Zdrowotnej, Myslowice, Slaskie, Poland
Wielkopolskie Centrum Onkologii, Poznan, Wielkopolskie, Poland
Russian Academy of Medical Sciences Institution, Moscow, , Russian Federation
State Educational Institution of Higher Professional Education, St-Petersburg, , Russian Federation
State healthcare institute, St-Petersburg, , Russian Federation
North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare, St.-Petersburg, , Russian Federation
Department of Urology, National University Hospital, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica, Banska Bystrica, , Slovakia
CUIMED s.r.o., Bratislava, , Slovakia
Univerzitna Nemocnica Martin, Martin, , Slovakia
UROEXAM, spol. s r.o. urologicka ambulancia, Nitra, , Slovakia
Poliklinika Sekcov, wesper, s.r.o., Presov, , Slovakia
UROCENTRUM MILAB s.r.o., Presov, , Slovakia
Hospital Universitario German Trias i Pujol, Badalona, Barcelona, Spain
Althaia Xarxa Asistencial Manresa, Manresa, Barcelona, Spain
Hospital Son Espases, Palma de Mallorca, Islas Baleares, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Complejo Hospitalario Universitario A Coruna, A Coruna, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Madrid Norte Sanchinarro, Madrid, , Spain
Corporacio Sanitaria Parc Tauli, Sabadell(Barcelona), , Spain
Sahlgrenska University Hospital, Gothenburg, , Sweden
Skane University Hospital, Malmo, , Sweden
Orebro University Hospital, Orebro, , Sweden
Karolinska University Hospital Solna, Stockholm, , Sweden
Umea University Hospital, Umea, , Sweden
Bishops Wood Hospital, Northwood, Middlesex, United Kingdom
Mount Vernon Hospital, Northwood, Middlesex, United Kingdom
Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Northern Centre for Cancer Care, Newcastle Upon Tyne, Tyne and Wear, United Kingdom
Velindre Cancer Centre, Cardiff, Wales, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, Merseyside, United Kingdom
Clinical Investigations and Research Unit, Royal Sussex County Hospital, Brighton, East Sussex, , United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol, , United Kingdom
Edinburgh Cancer Centre, Edinburgh, , United Kingdom
University College London Hospital NHS Trust, London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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