BAY88-8223, Dose Finding Study in Patients With HRPC
Completed
Bayer
Phase 2
The purpose of this study is to evaluate the effectiveness of the investigational
radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone
metastases that no longer respond to hormonal treatment.
A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer
Completed
Bayer
Phase 2
The purpose of this study is to evaluate the effectiveness of the investigational
radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no
longer respond to hormonal treatment.
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
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Completed
Bayer
Phase 3
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical
study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone
refractory prostate cancer and skeletal metastases.
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