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

Carolina Research Professionals, LLC31 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer Metastatic

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (5)

Chesapeake urology Research Associates

Towson, Maryland, United States

Urology Cancer Center and GU Research Network

Omaha, Nebraska, United States

Associated Medical Professionals

Syracuse, New York, United States

Oregon Urology Institute

Springfield, Oregon, United States