Clinical trial · Observational
Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone
Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan
- 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)
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).
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 |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CRPC patients
- description
- Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Primary outcomes (3)
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 7 months
- measure
- Incidence of drug-related TEAEs
- timeFrame
- Up to 7 months
- measure
- Descriptive analysis of long-term safety information during the extended follow-up period
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases * Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator * No contra-indications according to the local marketing authorization Exclusion Criteria: * Previously treated with Radium-223 for any reason * Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
References
Publications (1)
- DERIVEDHuang CY, Huang CP, Huang YY, Huang SK, Lu K, Huang WJ, Meng E, Huang SP, Lee MY, Chen F, Pang ST. Real-world safety and effectiveness of radium-223 in patients with metastatic castration-resistant prostate cancer: Interim analyses of the prospective, observational RAPIT study. Int J Cancer. 2024 Oct 1;155(7):1268-1277. doi: 10.1002/ijc.35040. Epub 2024 Jun 26. PMID 38924042