Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
NCT ID: NCT00676650
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
873 participants
INTERVENTIONAL
2008-07-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Treatment Arm A - sunitinib + prednisone
Prednisone
5 mg BID, oral
sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen
B
Treatment Arm B - placebo + prednisone
Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Prednisone
5 mg BID, oral
Interventions
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Prednisone
5 mg BID, oral
sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Prednisone
5 mg BID, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
* Progressive disease based on PSA progression, RECIST, or positive bone scan.
* ECOG 0 or 1.
Exclusion Criteria
* Chemotherapy within 3 weeks.
* Impending complications from bone metastases.
* Ongoing urinary obstruction.
* Cardiac dysfunction, QTc \>470 msec.
* CNS involvement.
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Decatur, Alabama, United States
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Huntsville, Alabama, United States
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Huntsville, Alabama, United States
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Anaheim, California, United States
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Encinitas, California, United States
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Glendale, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Modesto, California, United States
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Thousand Oaks, California, United States
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Thousands Oaks, California, United States
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Vista, California, United States
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Westlake Village, California, United States
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Denver, Colorado, United States
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Lafayette, Colorado, United States
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Gainesville, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Arlington Heights, Illinois, United States
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Niles, Illinois, United States
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Winfield, Illinois, United States
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Zion, Illinois, United States
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Carmel, Indiana, United States
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Fishers, Indiana, United States
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Greenfield, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Danvers, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Corinth, Mississippi, United States
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Southaven, Mississippi, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Sewell, New Jersey, United States
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New York, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Cary, North Carolina, United States
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Durham, North Carolina, United States
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Kernersville, North Carolina, United States
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Lexington, North Carolina, United States
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Mount Airy, North Carolina, United States
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North Wilkesboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Cleveland, Ohio, United States
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Mayfield Heights, Ohio, United States
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Mentor, Ohio, United States
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Orange, Ohio, United States
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Westlake, Ohio, United States
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Eugene, Oregon, United States
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Springfield, Oregon, United States
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Clairton, Pennsylvania, United States
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Greensburg, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Kingston, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Brighton, Tennessee, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Webster, Texas, United States
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Everett, Washington, United States
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Monroe, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Port Macquarie, New South Wales, Australia
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Wahroong, New South Wales, Australia
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Westmead, New South Wales, Australia
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Wodonga, Victoria, Australia
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Brussels, , Belgium
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Liège, , Belgium
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Mons, , Belgium
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Namur, , Belgium
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Wilrijk, , Belgium
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Salvador, Estado de Bahia, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Caxias do Sul, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santo André, São Paulo, Brazil
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Kelowna, British Columbia, Canada
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Barrie, Ontario, Canada
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Oshawa, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Wuhan, Hubei, China
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Beijing, , China
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Chongqing, , China
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Shanghai, , China
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Shanghai, , China
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Brno, , Czechia
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Olomouc, , Czechia
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Ústí nad Labem, , Czechia
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Herlev, , Denmark
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Koebenhavn Oe, , Denmark
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Odense C, , Denmark
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Vejle, , Denmark
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Helsinki, , Finland
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Tampere, , Finland
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Besançon, , France
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Bordeaux, , France
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Clermont-Ferrand, , France
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Lille, , France
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Lyon, , France
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Paris, , France
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Poitiers, , France
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Rennes, , France
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Rouen, , France
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Saint-Grégoire, , France
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Tours, , France
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Berlin, , Germany
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Homburg/Saar, , Germany
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Kempen, , Germany
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Leipzig, , Germany
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München, , Germany
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Münster, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Meldola, FC, Italy
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Lido Di Camaiore (LU), , Italy
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Napoli, , Italy
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Padua, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Potenza, , Italy
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Roma, , Italy
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Roma, , Italy
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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Bellavista, Provincia Constitucional del Callao, Peru
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Gdansk, , Poland
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Kielce, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Porto, , Portugal
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Porto, , Portugal
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Setúbal, , Portugal
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Martin, , Slovakia
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Prešov, , Slovakia
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Žilina, , Slovakia
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Goyang-si, Gyeonggi-do, South Korea
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Seongnam, Gyunggido, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, A Coruña, Spain
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Elche, Alicante, Spain
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Barcelona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Girona, Gerona, Spain
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Guadalajara, Guadalajara, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Seville, Sevilla, Spain
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Valencia, Valencia, Spain
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Vaxjo, , Sweden
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bournemouth, Dorset, United Kingdom
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Preston, Lancashire, United Kingdom
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Northwood, Middlesex, United Kingdom
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Bristol, , United Kingdom
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Cardiff, , United Kingdom
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Glasgow, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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London, , United Kingdom
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Sheffield, , United Kingdom
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Swansea, , United Kingdom
Countries
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References
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Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.
Related Links
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Other Identifiers
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A6181120
Identifier Type: -
Identifier Source: org_study_id
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