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

Prostate Cancer Metastatic Clinical Trial

— Post-eRADicAte  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03414437
• Other study ID #: CRP-PCA-01.1
• Status: Active, not recruiting
• Start date: October 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2019
• Source: Carolina Research Professionals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer Metastatic

Locations

Country	Name	City	State
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Cancer Center and GU Research Network	Omaha	Nebraska
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals	Syracuse	New York
United States	Chesapeake urology Research Associates	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Carolina Research Professionals, LLC	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the overall survival of subjects that completed the "eRADicAte" study.	Long term follow up	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
Primary	To investigate subsequent prostate cancer therapies and medications of subjects that completed the "eRADicAte" study.	Long term follow up	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
Primary	To investigate radiographic changes of subjects that completed the "eRADicAte" study.	Long term follow up	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
Primary	To investigate SSE's of subjects that completed the "eRADicAte" study	Long term follow up	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
Primary	To investigate the incidence of bone marrow failure of subjects that completed the "eRADicAte" study.	Long term follow up	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
Primary	To investigate the occurence of subsequent diagnosis with secondary malignancies of subjects that completed the "eRADicAte" study.	Long term follow up	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