Prostate Cancer MetastaticPost-eRADicAteNCT03414437
Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)
An observational study of Prostate Cancer Metastatic, run by Carolina Research Professionals, LLC at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- How many people
- 31 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2017to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- A living study subject or his legally authorized representative are not able to understand or willing to sign the written informed consent form.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
Oregon Urology Institute
Springfield, Oregon, 97477
Associated Medical Professionals
Syracuse, New York, 13210
Chesapeake urology Research Associates
Towson, Maryland, 21204
About this study
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.
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.
Read the 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
- Conditions
- Prostate Cancer Metastatic
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the overall survival of subjects that completed the "eRADicAte" study.
Long term follow up
Measured: 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.
Long term follow up
Measured: 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.
Long term follow up
Measured: 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
Long term follow up
Measured: 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.
Long term follow up
Measured: 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.
Long term follow up
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Oct 2017
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Research Professionals, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414437
- Sponsor's protocol ID
- CRP-PCA-01.1
- Acronym
- Post-eRADicAte
- Status last verified
- Mar 2019
- First submitted
- 19 Dec 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03414437
- Acronym / sponsor ID
- Post-eRADicAte / CRP-PCA-01.1
- Conditions
- Prostate Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Carolina Research Professionals, LLCUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- A living study subject or his legally authorized representative are not able to understand or willing to sign the written informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Metastatic, run by Carolina Research Professionals, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.