Prostate Cancer Clinical Trial
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
Summary
The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.
Eligibility Criteria
Inclusion criteria:
Must be ≥ 18 years of age
Confirmed and documented diagnosis of prostate cancer
Confirmed and documented evidence of progression of disease (hormone refractory)
Low testosterone levels
Chemotherapy-naïve
Exclusion criteria:
Recent radiation therapy (within 4 weeks)
Known brain metastasis
Peripheral neuropathy
Active diarrhea
Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
Allergic reactions to patupilone or docetaxel or prednisone or similar compounds
Other protocol-defined inclusion/exclusion criteria may apply
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There are 32 Locations for this study
La Jolla California, 92093, United States
Aurora Colorado, 80045, United States
Norwalk Connecticut, 06856, United States
Washington District of Columbia, 20007, United States
Orlando Florida, 32806, United States
Tampa Florida, 33612, United States
West Palm Beach Florida, 33401, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Jamaica New York, 11432, United States
Portland Oregon, 97239, United States
Kogarah New South Wales, 2217, Australia
South Brisbane Queensland, 4101, Australia
Parkville Victoria, 3050, Australia
Gent , 9000, Belgium
Bordeaux Cedex , 33075, France
Colmar Cedex , 68024, France
Lille Cedex , 59020, France
Rouen Cedex , 76031, France
Strasbourg , 67091, France
Toulouse Cedex 3 , 31052, France
Mannheim , 68135, Germany
Weiden , 92637, Germany
Milano MI, 20133, Italy
Milano MI, 20141, Italy
Perugia PG, 06129, Italy
Singapore , 16961, Singapore
Malaga AndalucÃa, 29010, Spain
Barcelona Catalunya, 08036, Spain
Valencia Comunidad Valenciana, 46009, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
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