Spots Global Cancer Trial Database for A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Study ID: NCT01946204
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.
Detailed Description: This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill. Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in previous Phase 2 studies. These studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Study participants will take the oral investigational medication daily. One cycle of study treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your cancer respond to the study medication. In order for the researchers to evaluate and compare the study results, there are two different study groups. Study participants will be randomly (like flipping a coin) assigned to one of these groups: * One group will receive their current treatment along with the investigational medication * One group will receive their current medications along with a placebo The investigational medication will be given to 2 out of every 3 study participants. Neither you nor the study staff will know which group you are in. However, in case of a medical emergency, your study doctor can quickly find out which treatment group you are in. All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and you may remain on investigational treatment until your disease worsens, or until significant side effects occur or you can no longer tolerate treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
, Birmingham, Alabama, United States
, Anchorage, Alaska, United States
, Chandler, Arizona, United States
, Tucson, Arizona, United States
, Duarte, California, United States
, Fullerton, California, United States
, Laguna Woods, California, United States
, Los Angeles, California, United States
, Orange, California, United States
, Roseville, California, United States
, Sacramento, California, United States
, San Bernardino, California, United States
, San Diego, California, United States
, San Francisco, California, United States
, Santa Monica, California, United States
, Sherman Oaks, California, United States
, Stanford, California, United States
, Tarzana, California, United States
, Torrance, California, United States
, Denver, Colorado, United States
, Englewood, Colorado, United States
, Glenwood Springs, Colorado, United States
, Grand Junction, Colorado, United States
, Washington, District of Columbia, United States
, Aventura, Florida, United States
, Boca Raton, Florida, United States
, Bradenton, Florida, United States
, Daytona Beach, Florida, United States
, Fort Myers, Florida, United States
, Hialeah, Florida, United States
, Jacksonville, Florida, United States
, Miami, Florida, United States
, New Port Richey, Florida, United States
, Orlando, Florida, United States
, Saint Petersburg, Florida, United States
, Sarasota, Florida, United States
, Wellington, Florida, United States
, Meridian, Idaho, United States
, Chicago, Illinois, United States
, Decatur, Illinois, United States
, Maywood, Illinois, United States
, Melrose Park, Illinois, United States
, Carmel, Indiana, United States
, Jeffersonville, Indiana, United States
, Muncie, Indiana, United States
, West Des Moines, Iowa, United States
, Westwood, Kansas, United States
, Wichita, Kansas, United States
, Metairie, Louisiana, United States
, New Orleans, Louisiana, United States
, Annapolis, Maryland, United States
, Baltimore, Maryland, United States
, Rockville, Maryland, United States
, Towson, Maryland, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, Lansing, Michigan, United States
, Minneapolis, Michigan, United States
, Royal Oak, Michigan, United States
, Duluth, Minnesota, United States
, Bay Saint Louis, Mississippi, United States
, Southaven, Mississippi, United States
, Kansas City, Missouri, United States
, Missoula, Montana, United States
, Omaha, Nebraska, United States
, Las Vegas, Nevada, United States
, Hooksett, New Hampshire, United States
, Hackensack, New Jersey, United States
, Lawrenceville, New Jersey, United States
, Morristown, New Jersey, United States
, Mount Laurel, New Jersey, United States
, New Brunswick, New Jersey, United States
, Voorhees, New Jersey, United States
, Albuquerque, New Mexico, United States
, Albany, New York, United States
, Bronx, New York, United States
, Mineola, New York, United States
, New York, New York, United States
, Oneida, New York, United States
, Poughkeepsie, New York, United States
, Syracuse, New York, United States
, Concord, North Carolina, United States
, Greensboro, North Carolina, United States
, Greenville, North Carolina, United States
, Salisbury, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Cincinnati, Ohio, United States
, Cleveland, Ohio, United States
, Middleburg Heights, Ohio, United States
, Middletown, Ohio, United States
, Bend, Oregon, United States
, Portland, Oregon, United States
, Tualatin, Oregon, United States
, Bala-Cynwyd, Pennsylvania, United States
, Bryn Mawr, Pennsylvania, United States
, Lancaster, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Warwick, Rhode Island, United States
, Charleston, South Carolina, United States
, Greenville, South Carolina, United States
, Myrtle Beach, South Carolina, United States
, West Columbia, South Carolina, United States
, Memphis, Tennessee, United States
, Nashville, Tennessee, United States
, Abilene, Texas, United States
, Amarillo, Texas, United States
, Dallas, Texas, United States
, Fort Sam Houston, Texas, United States
, Houston, Texas, United States
, McAllen, Texas, United States
, San Antonio, Texas, United States
, Norfolk, Virginia, United States
, Richmond, Virginia, United States
, Virginia Beach, Virginia, United States
, Burien, Washington, United States
, Edmonds, Washington, United States
, Seattle, Washington, United States
, Tacoma, Washington, United States
, Green Bay, Wisconsin, United States
, Madison, Wisconsin, United States
, Milwaukee, Wisconsin, United States
, Adelaide, , Australia
, Box Hill, , Australia
, Camperdown, , Australia
, Darlinghurst, , Australia
, Geelong, , Australia
, Gosford, , Australia
, Hobart, , Australia
, Kogarah, , Australia
, Liverpool, , Australia
, Melbourne, , Australia
, Nedlands, , Australia
, Parkville, , Australia
, South Woodville, , Australia
, Southport, , Australia
, Sydney, , Australia
, Tweed Heads, , Australia
, Wollongong, , Australia
, Graz, , Austria
, Innsbruck, , Austria
, Linz, , Austria
, Vienna, , Austria
, Brussels, , Belgium
, Brussel, , Belgium
, Gent, , Belgium
, Kortrijk, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Ottignies, , Belgium
, Calgary, Alberta, Canada
, Edmonton, Alberta, Canada
, Abbotsford, British Columbia, Canada
, Kelowna, British Columbia, Canada
, Vancouver, British Columbia, Canada
, Victoria, British Columbia, Canada
, Moncton, New Brunswick, Canada
, Saint John, New Brunswick, Canada
, Halifax, Nova Scotia, Canada
, Barrie, Ontario, Canada
, Brampton, Ontario, Canada
, Brantford, Ontario, Canada
, Hamilton, Ontario, Canada
, London, Ontario, Canada
, North York, Ontario, Canada
, Oakville, Ontario, Canada
, Ottawa, Ontario, Canada
, Owen Sound, Ontario, Canada
, Toronto, Ontario, Canada
, Gatineau, Quebec, Canada
, Granby, Quebec, Canada
, Greenfield Park, Quebec, Canada
, Laval, Quebec, Canada
, Montreal, Quebec, Canada
, Pointe-Claire, Quebec, Canada
, Sherbrooke, Quebec, Canada
, Quebec, , Canada
, Liberec, , Czechia
, Olomouc, , Czechia
, Opava, , Czechia
, Plzen, , Czechia
, Praha 2, , Czechia
, Praha 4, , Czechia
, Praha 5, , Czechia
, Praha, , Czechia
, Aalborg C, , Denmark
, Copenhagen, , Denmark
, Odense N/a, , Denmark
, Roskilde, , Denmark
, Helsinki, , Finland
, Oulu, , Finland
, Seinäjoki, , Finland
, Tampere, , Finland
, Turku, , Finland
, Angers Cedex 9, , France
, Angers, , France
, Besancon, , France
, Bordeaux, , France
, Caen Cédex 05, , France
, Clermont Ferrand, , France
, Hyers, , France
, La Roche sur Yon Cedex 9, , France
, Le Mans, , France
, Lille Cedex N/a, , France
, Lyon, , France
, Marseille cedex 5, , France
, Marseille Cedex 9, , France
, Nice Cedex 2, , France
, Nîmes Cedex 9, , France
, Paris 75, , France
, Paris Cedex 15, , France
, Paris, , France
, Reims Cedex, , France
, Rennes Cedex, , France
, Rouen, , France
, Saint Gregoire, , France
, Saint Herblain, , France
, Strasbourg, , France
, Suresnes, , France
, Tours, Cedex 9, , France
, Vandoeuvre Les Nancy Cedex, , France
, Aachen, , Germany
, Bergisch Gladbach, , Germany
, Berlin, , Germany
, Braunschweig, , Germany
, Duisburg, , Germany
, Emmendingen, , Germany
, Frankfurt / Main, , Germany
, Greifswald, , Germany
, Göttingen, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Heidelberg, , Germany
, Heinsberg, , Germany
, Homburg/Saar, , Germany
, Jena, , Germany
, Kiel, , Germany
, Kirchheim unter Teck, , Germany
, Köln, , Germany
, Magdeburg, , Germany
, Mainz, , Germany
, Mannheim, , Germany
, Marburg, , Germany
, Mettmann, , Germany
, Müllheim, , Germany
, Münster, , Germany
, Nuertingen, , Germany
, Regensburg, , Germany
, Rostock, , Germany
, Tübingen, , Germany
, Weiden, , Germany
, Wilhelmshaven, , Germany
, Wuppertan, , Germany
, Zirndorf, , Germany
, Budapest, , Hungary
, Miskolc, , Hungary
, Nyíregyhá, , Hungary
, Sopron, , Hungary
, Szentes, , Hungary
, Haifa, , Israel
, Jeruselem, , Israel
, Kfar-Saba, , Israel
, Petah-Tikva, , Israel
, Ramat Gan, , Israel
, Tel Aviv, , Israel
, Zerifin, , Israel
, Akita, , Japan
, Fukuoka-shi, , Japan
, Gifu, , Japan
, Hakodate, , Japan
, Hiroshima, , Japan
, Hokkaido, , Japan
, Kanazawa, , Japan
, Kashiwa, , Japan
, Kita-Gun, , Japan
, Kobe, , Japan
, Koshigaya, , Japan
, Kumamoto, , Japan
, Kurume, , Japan
, Matsuyama, , Japan
, Nagano, , Japan
, Nagasaki, , Japan
, Nagoya, , Japan
, Niigata, , Japan
, Osaka-Sayama, , Japan
, Osaka, , Japan
, Sagamihara, , Japan
, Sakura, , Japan
, Sapporo, , Japan
, Shinjuku-Ku, , Japan
, Tokushima, , Japan
, Tokyo, , Japan
, Ube, , Japan
, Wakayama, , Japan
, Yokohama, , Japan
, Daegu, , Korea, Republic of
, Gwangju-si, , Korea, Republic of
, Pusan, , Korea, Republic of
, Seongnam, , Korea, Republic of
, Seoul, , Korea, Republic of
, Alkmaar, , Netherlands
, Eindhoven, , Netherlands
, Hoofddorp, , Netherlands
, Leidschendam, , Netherlands
, Nijmegen, , Netherlands
, Rotterdam, , Netherlands
, Auckland, , New Zealand
, Christchurch, , New Zealand
, Hamilton, , New Zealand
, Nelson City, , New Zealand
, Tauranga, , New Zealand
, Whangarei, , New Zealand
, Nordbyhagen, , Norway
, Bialystok, , Poland
, Bydgoszcz, , Poland
, Gdansk, , Poland
, Kutno, , Poland
, Lodz, , Poland
, Poznan, , Poland
, Szczecin, , Poland
, Torun, , Poland
, Warszawa, , Poland
, Wroclaw, , Poland
, Baia Mare, , Romania
, Brasov, , Romania
, Bucharest, , Romania
, Cluj- Napoca, , Romania
, Targu Mures, , Romania
, Barnaul, , Russian Federation
, Ekaterinburg, , Russian Federation
, Ivanovo, , Russian Federation
, Moscow, , Russian Federation
, Obninsk, Kaluga Region, , Russian Federation
, Omsk, , Russian Federation
, Ryazan, , Russian Federation
, Saint Petersburg, , Russian Federation
, St. Petersburg, , Russian Federation
, Ufa, , Russian Federation
, Yaroslavl, , Russian Federation
, Banska Bystrica, , Slovakia
, Bratislava, , Slovakia
, Martin, , Slovakia
, Nitra, , Slovakia
, Trenčín, , Slovakia
, Badalona, , Spain
, Barcelona, , Spain
, Castellon, , Spain
, Coruña, , Spain
, Girona, , Spain
, Guadalajara, , Spain
, Jerez de la Frontera, , Spain
, Las Palmas De Gran Canaria, , Spain
, Madrid, , Spain
, Murcia, , Spain
, Málaga, , Spain
, Palma de Mallorca, , Spain
, Pamplona, , Spain
, Sabadell, , Spain
, Salamanca, , Spain
, San Sebastian de los Reyes, , Spain
, Santander, , Spain
, Sevilla N/a, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Goteborg, , Sweden
, Stockholm, , Sweden
, Umea, , Sweden
, Uppsala, , Sweden
, Örebro, , Sweden
, Kaohsiung, , Taiwan
, Taichung, , Taiwan
, Taipei, , Taiwan
, Taoyuan County, , Taiwan
, Blackburn, , United Kingdom
, Cambridge, , United Kingdom
, Cardiff, , United Kingdom
, Dundee, , United Kingdom
, Glasgow, , United Kingdom
, Guildford, , United Kingdom
, Leeds, , United Kingdom
, London, , United Kingdom
, Maidstone, , United Kingdom
, Nottingham, , United Kingdom
, Plymouth, , United Kingdom
, Southampton, , United Kingdom
, Surrey, , United Kingdom
, Swansea, , United Kingdom
, Wirral, , United Kingdom
, Wolverhampton, , United Kingdom
Contact Details
Name: Aragon Pharmaceuticals, Inc. Clinical Trial
Affiliation: Aragon Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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