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| ID | Type | Description | Link |
|---|---|---|---|
| XF 1503 | Other Identifier | NIS | |
| EUPAS24796 | Other Identifier | ENCePP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223) | patients with mCRPC with symptomatic bone metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223) | Drug | according to Summary of Product Characteristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to 60 months |
| 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 | |
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Inclusion Criteria:
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.
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The study population will consist of mCRPC patients with symptomatic bone metastases without known visceral metastases for whom the attending physician decided according to his/her medical practice to treat the patient with Radium-223 dichloride.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Germany |
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| 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 |
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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