Bone Metastatic Castration-resistant Prostate CancerDIRECTNCT04587427
A Study to Learn More About How Radium-223 is Being Used With Other Treatments in European Patients Who Have Not Received Radium-223 Before
An observational study of Bone Metastatic Castration-resistant Prostate Cancer, run by Bayer at 3 sites in 3 countries.
Trial summary
In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bone Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Radium 223 dichloride (Xofigo, BAY88-8223)
- How many people
- 1,067 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 May 2021to 30 May 2023
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include new users of radium-223 during the study periods captured in each data source. The study period will include time periods before and after the label change. The "before" period will start in November 2013, the month of radium-223 approval, and will end the in November 2017, the month when the first Direct Healthcare Professional Communication (DHCP) letter was sent. The "after" period will include an enrolment phase during which patients initiating radium-223 in each data source will be identified. The enrolment phase will last at least 1 year, starting in April 2019 (6 months after the label change), and will continue through a follow up phase of at least 6 months after the last new user of radium-223 is identified.
Who may be able to join
- Patients who receive a first dispensing/administration of radium-223 during the before or after study period
- Patients who have at least 6 months of continuous enrolment in the study databases before the first dispensing/administration of radium-223 (to allow for evaluation of recent medical history and medication use)
Who cannot join
- Patients who used radium-223 ever before the start of the before study period
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe
In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones.
The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed.
Read more
In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis.
The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020.
The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions.
They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions.
There are no required visits or tests in this study.
- Being tested
- Radium 223 dichloride (Xofigo, BAY88-8223)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium 223 dichloride (Xofigo, BAY88-8223)Drug
Prescribed by physicians.
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 | Subjects who received the treatment of radium-223 during the before or after label change study periods. Receives: Drug: Radium 223 dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who use radium-223 in combination with abiraterone acetate
Measured: Data will be collected from Nov 2013 to Dec 2020
The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
Measured: Data will be collected from Nov 2013 to Dec 2020
The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
Measured: Data will be collected from Nov 2013 to Dec 2020
Secondary outcomes (3)
The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate
Measured: Data will be collected from Nov 2013 to Dec 2020
The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
Measured: Data will be collected from Nov 2013 to Dec 2020
The difference between before and after the label change periods in the proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
Measured: Data will be collected from Nov 2013 to Dec 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 May 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587427
- Sponsor's protocol ID
- 20702
- Acronym
- DIRECT
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2020
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe
- ClinicalTrials.gov ID
- NCT04587427
- Acronym / sponsor ID
- DIRECT / 20702
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 14 Oct 2020 (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.
In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones.
The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed.
In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis.
The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020.
The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions.
They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions.
There are no required visits or tests in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 | – | Drug: Radium 223 dichloride (Xofigo, BAY88-8223)Subjects who received the treatment of radium-223 during the before or after label change study periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include new users of radium-223 during the study periods captured in each data source. The study period will include time periods before and after the label change. The "before" period will start in November 2013, the month of radium-223 approval, and will end the in November 2017, the month when the first Direct Healthcare Professional Communication (DHCP) letter was sent. The "after" period will include an enrolment phase during which patients initiating radium-223 in each data source will be identified. The enrolment phase will last at least 1 year, starting in April 2019 (6 months after the label change), and will continue through a follow up phase of at least 6 months after the last new user of radium-223 is identified.
Key inclusion criteria (2 listed)
- Patients who receive a first dispensing/administration of radium-223 during the before or after study period
- Patients who have at least 6 months of continuous enrolment in the study databases before the first dispensing/administration of radium-223 (to allow for evaluation of recent medical history and medication use)
Key exclusion criteria (1 listed)
- Patients who used radium-223 ever before the start of the before study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium 223 dichloride (Xofigo, BAY88-8223)Prescribed by physicians. | Drug | Radium-223 |
Primary outcome
The proportion of patients who use radium-223 in combination with abiraterone acetate
Time frame: Data will be collected from Nov 2013 to Dec 2020
The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
Time frame: Data will be collected from Nov 2013 to Dec 2020
The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
Time frame: Data will be collected from Nov 2013 to Dec 2020
3 secondary outcomes
The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate
Time frame: Data will be collected from Nov 2013 to Dec 2020
The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
Time frame: Data will be collected from Nov 2013 to Dec 2020
The difference between before and after the label change periods in the proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
Time frame: Data will be collected from Nov 2013 to Dec 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastatic Castration-resistant Prostate Cancer, run by Bayer at 3 sites in 3 countries.
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 2 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: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Germany, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients who use radium-223 in combination with abiraterone acetate (time frame: Data will be collected from Nov 2013 to Dec 2020). The study lists 3 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 8 Mar 2024.