Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases|
- Acute safety, variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From baseline to 30 days post-treatment ] [ Designated as safety issue: Yes ]Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry
- Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From 30 days post-treatment up to 3 years ] [ Designated as safety issue: Yes ]Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies
- Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form) [ Time Frame: From baseline up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Experimental: Radium-223 dichloride||
Drug: Radium-223 dichloride (BAY88-8223)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.