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Brief Title: Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT01193244
Brief Summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
, Anchorage, Alaska, United States
, Tucson, Arizona, United States
, Duarte, California, United States
, Highland, California, United States
, Orange, California, United States
, Sacramento, California, United States
, San Francisco, California, United States
, Aurora, Colorado, United States
, Denver, Colorado, United States
, Deerfield Beach, Florida, United States
, Fort Myers, Florida, United States
, Jacksonville, Florida, United States
, Orlando, Florida, United States
, Port St Lucie, Florida, United States
, Jeffersonville, Indiana, United States
, Kansas City, Kansas, United States
, New Orleans, Louisiana, United States
, Baltimore, Maryland, United States
, Boston, Massachusetts, United States
, Lansing, Michigan, United States
, Duluth, Minnesota, United States
, Corinth, Mississippi, United States
, Columbia, Missouri, United States
, Jefferson City, Missouri, United States
, Omaha, Nebraska, United States
, Las Vegas, Nevada, United States
, Hackensack, New Jersey, United States
, East Syracuse, New York, United States
, New York, New York, United States
, Durham, North Carolina, United States
, Raleigh, North Carolina, United States
, Kettering, Ohio, United States
, Tualatin, Oregon, United States
, Hershey, Pennsylvania, United States
, Lancaster, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Piitsburgh, Pennsylvania, United States
, Charleston, South Carolina, United States
, Columbia, South Carolina, United States
, Chattanooga, Tennessee, United States
, Nashville, Tennessee, United States
, Amarillo, Texas, United States
, Bedford, Texas, United States
, Dallas, Texas, United States
, Denton, Texas, United States
, Tyler, Texas, United States
, Salt Lake City, Utah, United States
, Norfolk, Virginia, United States
, Garran, , Australia
, Hobart, , Australia
, Kurralta Park, , Australia
, Nedlands, , Australia
, Perth, , Australia
, Redcliffe, , Australia
, Wodonga, , Australia
, Graz, , Austria
, Linz, , Austria
, Wien, , Austria
, Minsk, , Belarus
, Edegem, , Belgium
, Hasselt, , Belgium
, Kortrijk, , Belgium
, Leuven, , Belgium
, Namur, , Belgium
, Bairro Nazare - Salvador, , Brazil
, Barretos/sp, , Brazil
, Belo Horizonte, , Brazil
, Campinas, , Brazil
, Caxias Do Sul, , Brazil
, Curitiba, , Brazil
, Fortaleza/ce, , Brazil
, Ijui, , Brazil
, Joinville, , Brazil
, Lajeado - Rs, , Brazil
, Piracicaba - Sp, , Brazil
, Porto Alegre- Rs, , Brazil
, Porto Alegre/rs, , Brazil
, Ribeirao Preto - Sp, , Brazil
, Rio de Janeiro Rj, , Brazil
, Rio de Janeiro, , Brazil
, Santo Andre, , Brazil
, Sao Jose Do Rio Preto, , Brazil
, Sao Jose Dos Campos, , Brazil
, Sao Paulo, , Brazil
, Sorocaba - Sp, , Brazil
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Kelowna, British Columbia, Canada
, Burlington, Ontario, Canada
, Hamilton, Ontario, Canada
, London, Ontario, Canada
, Owen Sound, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Pointe Claire, Quebec, Canada
, Quebec City, Quebec, Canada
, Sherbrooke, Quebec, Canada
, Las Condes, , Chile
, Santiago, , Chile
, Temuco, , Chile
, Valparaiso, , Chile
, Cali, , Colombia
, Hradec Kralove, , Czech Republic
, Praha 4, , Czech Republic
, Praha 5, , Czech Republic
, Joensuu, , Finland
, Oulu, , Finland
, Seinajoki, , Finland
, Tampere, , Finland
, Angers, , France
, Bordeaux, , France
, Caen, , France
, Creteil, , France
, La Roche Sur Yon, , France
, Lyon, , France
, Marseille, , France
, Nancy, , France
, Nantes, , France
, Paris Cedex 13, , France
, Paris Cedex 14, , France
, Paris, , France
, Poitiers, , France
, Saint-etienne, , France
, Villejuif, , France
, Braunschweig, , Germany
, Dresden, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Kassel, , Germany
, Kempen, , Germany
, Nurtingen, , Germany
, Tubingen, , Germany
, Wuppertal, , Germany
, Athens, , Greece
, Heraklion Crete, , Greece
, Larissa, , Greece
, Patras, , Greece
, Thessaloniki, , Greece
, Kowloon, , Hong Kong
, Shatin, , Hong Kong
, Dublin, , Ireland
, Galway, , Ireland
, Haifa, , Israel
, Holon, , Israel
, Jerusalem, , Israel
, Petach Tikva, , Israel
, Ramat-gan, , Israel
, Tel Aviv, , Israel
, Zerifin, , Israel
, Aviano, , Italy
, Novara, , Italy
, Roma, , Italy
, Torino, , Italy
, Chiba-city, , Japan
, Chiba, , Japan
, Fukuoka, , Japan
, Hamamatsu City, , Japan
, Hokkaido, , Japan
, Kanazawa, , Japan
, Kita-gun, , Japan
, Maebashi-city, , Japan
, Mito-city, , Japan
, Osaka-city, , Japan
, Osaka, , Japan
, Sakura City, , Japan
, Sayama, , Japan
, Sendai City, , Japan
, Shimizucho Sunto-gun, , Japan
, Suntou-gun, , Japan
, Tokyo, , Japan
, Yamagata City, , Japan
, Yokohama City, , Japan
, Yufu-city, , Japan
, Riga, , Latvia
, Kaunas, , Lithuania
, Klaipeda, , Lithuania
, Vilnius, , Lithuania
, Durango Durango, , Mexico
, Mexico City Distrito Federal, , Mexico
, Zapopan Jalisco, , Mexico
, Amsterdam, , Netherlands
, Arnhem, , Netherlands
, Breda, , Netherlands
, Eindhoven, , Netherlands
, Heerlen, , Netherlands
, Nieuwegein, , Netherlands
, Nijmegen, , Netherlands
, Rotterdam, , Netherlands
, Auckland, , New Zealand
, Christchurch, , New Zealand
, Dunedin, , New Zealand
, Takapuna, , New Zealand
, Tauranga, , New Zealand
, Lima, , Peru
, Bielsko-biala, , Poland
, Wroclaw, , Poland
, Liepaja, , Portugal
, Lisboa, , Portugal
, Porto, , Portugal
, San Juan, , Puerto Rico
, Bucharest, , Romania
, Cluj-napoca, , Romania
, Moscow, , Russian Federation
, St Petersburg, , Russian Federation
, Singapore, , Singapore
, Nitra, , Slovakia
, Presov, , Slovakia
, Trencin, , Slovakia
, Zilina, , Slovakia
, Cape Town, , South Africa
, Durban, , South Africa
, George, , South Africa
, Port Elizabeth, , South Africa
, Barcelona, , Spain
, La Coruna, , Spain
, Madrid, , Spain
, Majadahonda, , Spain
, Pamplona, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Goteborg, , Sweden
, Stockholm, , Sweden
, Uppsala, , Sweden
, Aarau, , Switzerland
, Lausanne, , Switzerland
, Winterthur, , Switzerland
, Zurich, , Switzerland
, Taichung, , Taiwan
, Taipei, , Taiwan
, Dnipropetrovsk, , Ukraine
, Donetsk, , Ukraine
, Kyiv, , Ukraine
, Zaporizhzhya, , Ukraine
, Aberdeen, , United Kingdom
, Belfast, , United Kingdom
, Bristol, , United Kingdom
, Cottingham, , United Kingdom
, Coventry, , United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Northwood, , United Kingdom
, Preston, , United Kingdom
, Southampton, , United Kingdom
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR