Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone

Study Overview
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Brief Summary
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In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description
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The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan. The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.

Official Title
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Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan

Conditions
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Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator No contra-indications according to the local marketing authorization Exclusion Criteria: Previously treated with Radium-223 for any reason Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRPC patients<br>Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Drug administration as determined by treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) |  | Up to 7 months | 
| Incidence of drug-related TEAEs |  | Up to 7 months | 
| Descriptive analysis of long-term safety information during the extended follow-up period | This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 2 years | 
| Time to the first symptomatic skeletal event (SSE) |  | Up to 2 years | 
| Proportion of patients with total ALP (tALP) response | ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase | Up to 2 years | 
| Proportion of patients with PSA response | PSA - Prostate Specific Antigen | Up to 2 years | 
| Change in pain status | Pain status is assessed through analgesic utility that is calculated by WHO analgesic scores (0 - none, 1 - non-opioid, 2 - opioid for mild to moderate pain, 3 - opioid for moderate to severe pain) | Up to 2 years | 
| Change in ECOG-PS | The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death). | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone metastases, Radium-223 dichloride