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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRPC patients | Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Drug administration as determined by treating physician |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients in routine clinical practice from Taiwan
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Taiwan |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 |
| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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