The purpose of this study is to evaluate the efficacy and safety of the investigational
radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and
bone metastases that no longer respond to hormonal treatment.
Primary objective: To investigate the biodistribution, radiation dosimetry, and
pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body
weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology
standardization], 6 weeks apart).
Secondary objectives: To determine the safety of IV injections of Xofigo after two separate
injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic
bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w.
(=110 kBq/kg based on the 2015 National Institute of Standards and Technology
standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect
survival data at 6 and 12 months after the first injection
Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton
Completed
Bayer
Phase 1
2008-08-01
The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry
and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
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