To evaluate the safety and efficacy (Overall survival \[OS\]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
243
Radium-223 dichloride, 55 kBq/kg body weight, will be administered as a slow bolus IV injection at 4 week intervals for up to 6 doses.
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Guangzhou, Guangdong, China
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 36 months
Number of participants with laboratory changes
Time frame: Up to 36 months
Number of participants with changes in vital signs
Time frame: Up to 36 months
Number of participants with changes in electrocardiogram (ECG)
Time frame: Up to 36 months
Overall Survival (OS)
OS is defined as the time from date of first study drug treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: Up to 36 months
Changes in total Alkaline Phosphate (ALP) in serum
Time frame: Up to 36 months
Number of participants with total-ALP normalization
Time frame: Up to 36 months
Time to total ALP progression
Time frame: Up to 36 months
Changes in prostate specific antigen (PSA) in serum
Time frame: Up to 36 months
Time to PSA progression
Time frame: Up to 36 months
Time to first skeletal related event (SRE)
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Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Guangzhou, China
...and 17 more locations
Time frame: Up to 36 months
SRE free survival
Time frame: Up to 36 months
Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms
Time frame: Up to 36 months
Time to occurrence of first start of any other anti-cancer treatment
Time frame: Up to 36 months
Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: Up to 36 months
Quality of life (QoL)
QoL is assessed by the scores got from the Functional Assessment of Cancer Therapy in subjects with prostate cancer (FACT-P) questionnaire, EuroQoL (EQ-5D) questionnaire, and the BPI-SF questionnaire.
Time frame: Up to 36 months
Time to pain progression
Time frame: Up to 36 months