Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
Study Details
Study Description
Brief Summary
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.
During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.
The extended follow-up period is to collect bone fractures and survival with post-treatment information after Xofigo under the real-world in Japan.
The results of this study (except of extended follow-up period) have to be submitted to the Japanese regulatory authorities as a part of the reexamination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Xofigo / Cohort 1 Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice. |
Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)
Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events as a measure of safety [Up to 6 months]
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
- Number of adverse drug reactions as a measure of safety [Up to 6 months]
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
Secondary Outcome Measures
- Change in laboratory findings (e.g. ALP, bone markers) [From Baseline up to 6 month]
- Change in analgesic use as a surrogate of pain status [From Baseline up to 6 month]
- Number of patients with bone fractures [Up to 3 years]
- Survival rate [Up to 3 years]
- Post-treatment information [Up to 3 years]
Comprises information of post-treatment medication/ therapy for prostate cancer
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients suffered from CRPC with bone metastases
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Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice.
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Xofigo treatment naïve
Exclusion Criteria:
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Patients treated Xofigo previously
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Patients participating in an investigational program with interventions outside of routine clinical practice
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Japan |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 18212