Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223

Study Overview
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Brief Summary
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This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.

Detailed Description
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Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers). Moreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres). All above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome.

Official Title
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Registry of Treatment Outcomes in a Non-study Population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223

Conditions
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Prostate Cancer Metastatic, Bone Metastases

Intervention / Treatment
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* Diagnostic Test: Blood tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At the physicians discretion Age 18 year and older. Written informed consent Exclusion Criteria: Previous treatment with Radium-223. Participation in another Radium-223 study.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Blood tests|Blood tests for several bone markers (see summary)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment on pain outcomes, as mentioned by the patient | Evaluate Radium-223 treatment efficacy by patient, by several questionnaires (FACT-P, BPI-S and use of painmedication). | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 
| Efficacy of treatment by patient records | But also by patient records (records of bonescans, CT scans, blood measurements, out-patient clinic visits). All of these assessments will be combined to come to a final reported value (Progressive disease, stable disease, partial remission or complete remission) | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic Skeletal Event | To evaluate the efficacy of Radium-223 treatment in a nonstudy population by effects on Symptomatic Skeletal Event (SSE). Through patient records and questionnairs (FACT-P, BPI-S and use of painmedication). | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 
| Clinical Parameters assessed by the WHO PS. | Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS) | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events). | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 
| Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Evaluate of the treatment after Radium-223 the treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events). | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 
| Biomarkers | Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy | through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radium-223