Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany

Study Overview
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Brief Summary
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This observational prospective single arm cohort study is designed to assess overall survival, symptomatic skeletal event free survival and quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and selfcare, independence in activities of daily living and safety will be assessed.

Official Title
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URANIS -Data Collection in Urological Centers During Treatment With Ra-223 Dichloride (Xofigo) Within the Framework of a Non-interventional Study Assessing Overall Survival (OS) and Effectiveness Predictors of Ra-223 Dichloride Treated mCRPC Patients in a Real Life Setting in Germany.

Conditions
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Prostatic Neoplasms, Castration-Resistant

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: Male patients diagnosed with castration resistant adenocarcinoma of the prostate (CRPC) with symptomatic bone metastases without known visceral metastases Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice Exclusion Criteria: -Patients participating in an investigational program with interventions outside of routine clinical practice and also in all non-interventional studies focusing on Radium- 223-dichloride.

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>patients with mCRPC with symptomatic bone metastases | Drug: Radium-223-dichloride (Xofigo, BAY88-8223)<br>* according to Summary of Product Characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients |  | Up to 60 months | 
| Estimation of the incidence of pathological fractures. |  | Up to 60 months | 
| Time to next tumor treatment(s) (TTNT) |  | Up to 24 months | 
| Incidence of treatment-emergent adverse events (TEAE) |  | Up to 30 days after last administration of Radium-223 | 
| Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire | The FACT-P questionnaire version 4 is a 39-item questionnaire consisting of five domains; 'Physical well-being', 'Social/Family well-being', 'Emotional well-being', 'Functional well-being' and 'Additional concerns' (consisting of items relating specifically to prostate cancer and/or its treatment) and uses a 0-4 Likert-scale. | Up to 60 months | 
| Activities of daily living assessed according to the Katz-Index |  | Up to 7 months | 
| Body function assessed in dimensions of mobility, self-care and domestic life using the Medical Oncology Status in Europe Survey (MOSES) questionnaire |  | Up to 7 months | 
| Estimation of the non-pathological fractures |  | Up to 60 months | 
| Estimation of the bone associated events |  | Up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mCRPC