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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
185
Antitumor response based on PSA decrease
Time frame: Every 3 weeks
Measurable soft tissue response for both regimens
Time frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan
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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 D.C., 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
...and 22 more locations