An observational study in Prostatic Neoplasms, Castration-Resistant, sponsored by Bayer. Completed at 1 site in Japan. Open to male participants. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Bayer · Observational
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.
83 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 29 are open to participants now.
This study's enrollment of 334 is below the median of 500 across 15 observational studies indexed under Prostatic Neoplasms, Castration-Resistant.
Browse Prostatic Neoplasms, Castration-Resistant studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients suffered from castration resistant prostate cancer with bone metastases
Exclusion Criteria:
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.
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
Time frame: 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
Time frame: Up to 6 months
Change in laboratory findings (e.g. ALP, bone markers)
Time frame: From Baseline up to 6 month
Change in analgesic use as a surrogate of pain status
Time frame: From Baseline up to 6 month
Number of patients with bone fractures
Time frame: Up to 3 years
Survival rate
Time frame: Up to 3 years
Post-treatment information
Comprises information of post-treatment medication/ therapy for prostate cancer
Time frame: Up to 3 years
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Prostatic Neoplasms, Castration-Resistant→
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