Clinical trial · Observational
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
NCT02803437CI-TRIAL-00091955completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY 88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Xofigo / Cohort 1
- description
- Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)
Primary outcomes (2)
- measure
- Number of adverse events as a measure of safety
- timeFrame
- Up to 6 months
- description
- Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
- measure
- Number of adverse drug reactions as a measure of safety
- timeFrame
- Up to 6 months
- description
- Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Patients suffered from CRPC with bone metastases * Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice. * Xofigo treatment naïve Exclusion Criteria: * Patients treated Xofigo previously * Patients participating in an investigational program with interventions outside of routine clinical practice
References
Publications (4)
- RESULTHosono 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. PMID 34645727
- RESULTUemura 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. PMID 33575828
- RESULTMasumori 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
- RESULTTakahashi 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