Clinical trial NCT03414437: Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer Metastatic
Lead sponsor: Carolina Research Professionals, LLC
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2018-01-30
Enrollment: 31
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The evaluable population includes 31 subjects that completed the eRADicAte study. This population will be used for the analysis of the primary efficacy endpoint.

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

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.

Primary outcomes:
measure: To investigate the overall survival of subjects that completed the "eRADicAte" study.
timeFrame: 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
measure: To investigate subsequent prostate cancer therapies and medications of subjects that completed the "eRADicAte" study.
timeFrame: 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
measure: To investigate radiographic changes of subjects that completed the "eRADicAte" study.
timeFrame: 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
measure: To investigate SSE's of subjects that completed the "eRADicAte" study
timeFrame: 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
measure: To investigate the incidence of bone marrow failure of subjects that completed the "eRADicAte" study.
timeFrame: 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
measure: To investigate the occurence of subsequent diagnosis with secondary malignancies of subjects that completed the "eRADicAte" study.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Towson
country: United States
facility: Chesapeake urology Research Associates
state: Maryland
city: Omaha
country: United States
facility: Urology Cancer Center and GU Research Network
state: Nebraska
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
Study officials:
References: