CLINICAL TRIALS PROFILE FOR RADIUM-223

Clinical Trials for Radium-223

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00337155 ↗	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.
NCT00459654 ↗	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.
NCT00667199 ↗	BAY88-8223, Does Response Study in HRPC Patients	Completed	Bayer	Phase 2	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.
NCT00667537 ↗	PK in Pts With HRPC & Skeletal Metastes	Completed	Bayer	Phase 1	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
NCT00699751 ↗	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.

Clinical Trial Conditions for Radium-223

Condition Name

Condition Name
Intervention	Trials
Prostate Cancer	21
Prostatic Neoplasms	12
Bone Metastases	8
Metastatic Castration-resistant Prostate Cancer	5

Condition MeSH

Condition MeSH
Intervention	Trials
Prostatic Neoplasms	65
Neoplasm Metastasis	18
Carcinoma	9
Bone Neoplasms	7

Clinical Trial Locations for Radium-223

Trials by Country

Trials by Country
Location	Trials
United States	352
Italy	83
United Kingdom	64
Spain	61
Germany	56

Trials by US State

Trials by US State
Location	Trials
California	22
New York	18
Maryland	17
North Carolina	16
Michigan	16

Clinical Trial Progress for Radium-223

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	11
Phase 2	35

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	29
Recruiting	19
Active, not recruiting	15

Clinical Trial Sponsors for Radium-223

Sponsor Name

Sponsor Name
Sponsor	Trials
Bayer	45
National Cancer Institute (NCI)	6
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	4

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	61
Other	57
NIH	6