Prostate Cancer Clinical Trial

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

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.

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Full 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

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Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

31

Study ID:

NCT03414437

Recruitment Status:

Unknown status

Sponsor:

Carolina Research Professionals, LLC

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There are 5 Locations for this study

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Chesapeake urology Research Associates
Towson Maryland, 21204, United States
Urology Cancer Center and GU Research Network
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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

31

Study ID:

NCT03414437

Recruitment Status:

Unknown status

Sponsor:


Carolina Research Professionals, LLC

How clear is this clinincal trial information?

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