Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases. This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
Tablets taken orally once daily.
Given by IV once every 3 weeks.
Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
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Scottsdale, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Marina del Rey, California, United States
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Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported
The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.
Time frame: Pain response was measured at Week 6 and Week 12 by self-reports of subjects
Bone Scan Response (BSR)
BSR is defined as \>=30% in the bone scan lesion area (BSLA) compared with baseline. Bones 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
Overall Survival (OS)
OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates.
Time frame: OS was measured at the time of randomization until 78 deaths
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San Diego, California, United States
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San Francisco, California, United States
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Santa Barbara, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
...and 72 more locations