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

March 15, 2019 updated by: Carolina Research Professionals, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Urology Cancer Center and GU Research Network
    • New York
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Institute
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To investigate the overall survival of subjects that completed the "eRADicAte" study.
Time Frame: 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
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
To investigate subsequent prostate cancer therapies and medications of subjects that completed the "eRADicAte" study.
Time Frame: 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
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
To investigate radiographic changes of subjects that completed the "eRADicAte" study.
Time Frame: 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
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
To investigate SSE's of subjects that completed the "eRADicAte" study
Time Frame: 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
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
To investigate the incidence of bone marrow failure of subjects that completed the "eRADicAte" study.
Time Frame: 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
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
To investigate the occurence of subsequent diagnosis with secondary malignancies of subjects that completed the "eRADicAte" study.
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carolina Research Professionals, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRP-PCA-01.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

31 subjects will be enrolled. The sample size is based on the number of subjects that completed the "eRADicAte" study. No statistical assumptions are made.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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