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Brief Title: Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
Official Title: A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer
Study ID: NCT00411528
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of California San Diego Dept of Moores Cancer Center, La Jolla, California, United States
University of Colorado Dept. of Univ. of Colorado, Aurora, Colorado, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center, Washington, District of Columbia, United States
MD Anderson Cancer Center - Orlando CEPO906A2229, Orlando, Florida, United States
H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology, Tampa, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
NorthWest Georgia Oncology Centers Marietta Center, Marietta, Georgia, United States
University Chicago Hospital StudyCoordinator:CEPO906A2229, Chicago, Illinois, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York, United States
Oregon Health & Science University StudyCoordinator:CEPO906A2229, Portland, Oregon, United States
Novartis Investigative Site, Kogarah, New South Wales, Australia
Novartis Investigative Site, South Brisbane, Queensland, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Bordeaux Cedex, , France
Novartis Investigative Site, Colmar Cedex, , France
Novartis Investigative Site, Lille Cedex, , France
Novartis Investigative Site, Rouen Cedex, , France
Novartis Investigative Site, Strasbourg, , France
Novartis Investigative Site, Toulouse Cedex 3, , France
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Weiden, , Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Perugia, PG, Italy
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Malaga, Andalucía, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR