Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/21/2019
Start Date:October 1, 2017
End Date:October 1, 2021

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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.

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

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.
We found this trial at
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Towson, MD
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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Myrtle Beach, SC
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Omaha, NE
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Springfield, Oregon 97477
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Springfield, OR
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Syracuse, New York 13210
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Syracuse, NY
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