This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,028
Tablets taken orally once-daily
Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
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Birmingham, Alabama, United States
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Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Overall Survival (OS)
The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.
Time frame: OS was measured from the time of randomization until 614 events, approximately 24 months after study start
Bone Scan Response (BSR)
BSR is defined as \>=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.
Time frame: BSR was measured at the end of Week 12 as determined by the IRF
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Jonesboro, Arkansas, United States
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Duarte, California, United States
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Highland, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
...and 254 more locations