Prostate Cancer Clinical Trial
Official title:
Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis
This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will
receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and
concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks.
Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All
adverse events deemed to be study related will be followed until resolution. Including
screening, the total duration of the study is 32 weeks.
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