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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood tests | Diagnostic Test | Blood tests for several bone markers (see summary) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Men with prostate cancer and bone metastasis, which are to be treated with Radium-223.
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| Name | Affiliation | Role |
|---|---|---|
| Andre Bergman, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Netherlands Cancer Intitute | Amsterdam | 1066CX | Netherlands | |||
| Franciscus Gasthuis & Vlietland |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Extra blood will be collected at baseline, 1st, 2nd, 3rd and 6th (or last) Radium-223 treatment. Changes in serum and blood levels of biomarkers of bone metabolism and levels of blood osteoclast precursors in Radium-223 treated patients will e evaluated for their potential to predict treatment outcome.
| 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) |
| Rotterdam |
| Netherlands |