Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

Study Overview
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Brief Summary
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Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Official Title
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Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Conditions
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Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases Signed informed consent Exclusion Criteria: Previously treated with Radium-223 for any reason Currently treated in clinical trials including other Radium-223 studies Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radium-223 dichloride (Xofigo, BAY88-8223)<br>Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223. | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of developing second primary malignancies |  | From study start to 7 years post last dose of Radium-223 | 
| Incidence of treatment-emergent SAEs |  | From study start up to 30 days after the last administration of Radium-223 | 
| Incidence of drug-related treatment-emergent adverse events |  | From study start up to 30 days after the last administration of Radium-223 | 
| Incidence of drug-related SAEs |  | From study start to 7 years post last dose of Radium-223 | 
| Bone marrow suppression | Therapeutic/prevention measures/treatment modalities, Gr. 3/4 hematological toxicities (up to 6 months after last administration), platelet or WBC < lower limit of normal during treatment +30 days will be followed to resolution (up to 6 months after last administration), and febrile neutropenia and hemorrhage for patients who start subsequent chemotherapy will be assessed. | From study start to 6 months post last dose of Radium-223 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From study start to 7 years post last dose of Radium-223 | 
| The worst pain score and pain interference score over time as determined by patient responses on the Brief pain inventory short form (BPI-SF) questionnaire |  | From study start to 6 months post last dose of Radium-223 | 
| Incidence of bone fractures |  | From study start to 7 years post last dose of Radium-223 | 
| The number of bone associated events | e.g. osteoporosis | From study start to 7 years post last dose of Radium-223 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radium-223, CRPC, Phase IV, Safety study