Post-eRADicAte: A Long Term Follow up to eRADicAte (NCT 02097303), an Open Label Phase Two Study of RADium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in CRPC Subjects With Symptomatic Bone Metastasis.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 31
- Locations
- 5
- Primary Endpoint
- To investigate the overall survival of subjects that completed the "eRADicAte" study.
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible subjects are adults over the age of 18 with mCRPC that completed the eRADicAte study. The living study subject or legally authorized representative must be able to understand and sign the written informed consent form.
Exclusion Criteria
- •A living study subject or his legally authorized representative are not able to understand or willing to sign the written informed consent form.
Outcomes
Primary Outcomes
To investigate the overall survival of subjects that completed the "eRADicAte" study.
Time Frame: 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
Long term follow up
To investigate subsequent prostate cancer therapies and medications of subjects that completed the "eRADicAte" study.
Time Frame: 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
Long term follow up
To investigate radiographic changes of subjects that completed the "eRADicAte" study.
Time Frame: 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
Long term follow up
To investigate SSE's of subjects that completed the "eRADicAte" study
Time Frame: 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
Long term follow up
To investigate the incidence of bone marrow failure of subjects that completed the "eRADicAte" study.
Time Frame: 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
Long term follow up
To investigate the occurence of subsequent diagnosis with secondary malignancies of subjects that completed the "eRADicAte" study.
Time Frame: 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
Long term follow up
Secondary Outcomes
No secondary outcomes reported