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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects of Radium Ra 223 dichloride with concurrent administration of Abiraterone Acetate plus Prednisone Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastasis.
This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases.
31 subjects completed all study visits in the eRADicAte study, and were thus evaluable. All 31 subjects will be asked to participate in this Long Term Follow Up study which will evaluate overall survival, subsequent additional prostate cancer therapies and medications, radiographic changes and SSE's (Symptomatic Skeletal Events), incidence of bone marrow failure, and diagnosis with secondary malignancies.
Living subjects will be evaluated at least 12 weeks after their last dose of Radium Ra 223 dichloride and at each subsequent clinic visit. Deceased subject's data will be obtained retrospectively, from 12 weeks after the eRADicAte End of Treatment visit and prospectively through the date of death. The total duration of the study is expected to be 48 months
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| Measure | Description | Time Frame |
|---|---|---|
| To investigate the overall survival of subjects that completed the "eRADicAte" study. | Long term follow up | From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years |
| To investigate subsequent prostate cancer therapies and medications of subjects that completed the "eRADicAte" study. | Long term follow up | From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years |
| To investigate radiographic changes of subjects that completed the "eRADicAte" study. | Long term follow up | From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years |
| To investigate SSE's of subjects that completed the "eRADicAte" study | Long term follow up | From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years |
| To investigate the incidence of bone marrow failure of subjects that completed the "eRADicAte" study. | Long term follow up | From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years |
| To investigate the occurence of subsequent diagnosis with secondary malignancies of subjects that completed the "eRADicAte" study. | Long term follow up |
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Inclusion Criteria:
Exclusion Criteria:
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The evaluable population includes 31 subjects that completed the eRADicAte study. This population will be used for the analysis of the primary efficacy endpoint.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake urology Research Associates | Towson | Maryland | 21204 | United States | ||
| Urology Cancer Center and GU Research Network |
31 subjects will be enrolled. The sample size is based on the number of subjects that completed the "eRADicAte" study. No statistical assumptions are made.
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| From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years |
| Omaha |
| Nebraska |
| 68130 |
| United States |
| Associated Medical Professionals | Syracuse | New York | 13210 | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |