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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY 88-8223) | Drug | Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events as a measure of safety | Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system | Up to 6 months |
| Number of adverse drug reactions as a measure of safety | Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffered from castration resistant prostate cancer with bone metastases
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34645727 | Result | Hosono M, Uemura H, Kakehi Y, Masumori N, Takahashi S, Okayama Y, Sunaya T, Horio T, Kinuya S. [Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age]. Kaku Igaku. 2021;58(1):91-101. doi: 10.18893/kakuigaku.oa.2105. Japanese. | |
| 33575828 |
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| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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| Number of patients with bone fractures |
| Up to 3 years |
| Survival rate | Up to 3 years |
| Post-treatment information | Comprises information of post-treatment medication/ therapy for prostate cancer | Up to 3 years |
| Uemura H, Masumori N, Takahashi S, Hosono M, Kinuya S, Sunaya T, Horio T, Okayama Y, Kakehi Y. Real-world safety and effectiveness of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastasis: exploratory analysis, based on the results of post-marketing surveillance, according to prior chemotherapy status and in patients without concomitant use of second-generation androgen-receptor axis-targeted agents. Int J Clin Oncol. 2021 Apr;26(4):753-763. doi: 10.1007/s10147-020-01850-3. Epub 2021 Feb 11. |
| Result | Masumori N, Kakehi Y, Hosono M, Kinuya S, Takahashi S, Okayama Y, Sunaya T, Horio T, Uemura H (2020) Post-marketing Surveillance (PMS) Study for Safety and Effectiveness of Radium-223 in Japanese Patients with CRPC and Bone Metastases in Real-world Settings: Exploratory Analysis on Treatment Completion of Six Cycles of Radium-223 and Discontinuation. Medical Consultation & New Remedies 57:705-717 |
| Result | Takahashi S, Uemura H, Masumori N, Kinuya S, Hosono M, Okayama Y, Sunaya T, Horio T, Kakehi Y (2020) Safety and effectiveness of radium-223 in Japanese patients with CRPC and bone metastases in real world-settings: The results of post-marketing surveillance (PMS). Japanese Journal of Urological Surgery 33(4):435-449 |
| D009369 |
| Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |