Metastatic Castration Resistant Prostate Cancer (mCRPC)EPIXNCT04516161
EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
An observational study of Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Bayer at 1 site in United States.
Trial summary
In this observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 1,180 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mCRPC who received Ra-223 from the Bayer Flatiron Xofigo Registry database (BFXR, Version Mar, 2020 with a data cutoff date of Dec, 2019). The database currently includes 1,372 patients with mCRPC who received Ra-223.
Who may be able to join
- Adult patients with documented diagnosis of mCRPC (≥18 years at diagnosis), and
- Received Ra-223 as one of the therapies between Jan 1, 2013 and Jun 31, 2019 after diagnosis of mCRPC
Who cannot join
- Patients involved in clinical trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Bayer Flatiron Xofigo Registry database
Whippany, New Jersey, 07981
About this study
Official title: Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo): Patient Characteristics and Predictors of Long-term Survival
In this observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mCRPC). In addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
- 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
Receiving Ra-223 either alone or in combination with other cancer therapies at any time after diagnosis of mCRPC
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Patients with mCRPC who received treatment of Ra-223. 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.
Overall survival from initiation of Ra-223
Measured: Retrospective analysis from Jan 2013 to Dec 2019
Secondary outcomes (1)
Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223
PSA response will be defined ≥ 50% reduction in baseline PSA level after initiation of Ra-223
Measured: Retrospective analysis from Jan 2013 to Dec 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start3 Aug 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)Studies 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
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516161
- Sponsor's protocol ID
- 20977
- Acronym
- EPIX
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2020
- Last updated
- 31 Mar 2022
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Publications
George DJ, Agarwal N, Sartor O, Sternberg CN, Tombal B, Saad F, Miller K, Constantinovici N, Guo H, Reeves J, Jiao X, Sandstrom P, Verholen F, Higano CS, Shore N. Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study). Prostate Cancer Prostatic Dis. 2022 Feb;25(2):306-313. doi: 10.1038/s41391-021-00488-0. Epub 2022 Feb 21.
PubMed 35190653
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo): Patient Characteristics and Predictors of Long-term Survival
- ClinicalTrials.gov ID
- NCT04516161
- Acronym / sponsor ID
- EPIX / 20977
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 18 Aug 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 observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mCRPC). In addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Patients with mCRPC who received treatment of Ra-223. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mCRPC who received Ra-223 from the Bayer Flatiron Xofigo Registry database (BFXR, Version Mar, 2020 with a data cutoff date of Dec, 2019). The database currently includes 1,372 patients with mCRPC who received Ra-223.
Key inclusion criteria (2 listed)
- Adult patients with documented diagnosis of mCRPC (≥18 years at diagnosis), and
- Received Ra-223 as one of the therapies between Jan 1, 2013 and Jun 31, 2019 after diagnosis of mCRPC
Key exclusion criteria (1 listed)
- Patients involved in clinical trials
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)Receiving Ra-223 either alone or in combination with other cancer therapies at any time after diagnosis of mCRPC | Drug | Radium-223 dichloride (Xofigo, BAY88-8223) |
Primary outcome
Overall survival from initiation of Ra-223
Time frame: Retrospective analysis from Jan 2013 to Dec 2019
1 secondary outcome
Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223
Time frame: Retrospective analysis from Jan 2013 to Dec 2019
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 31 Mar 2022.
- Derived from this study: PubMed 35190653George DJ, Agarwal N, Sartor O, Sternberg CN, Tombal B, Saad F, Miller K, Constantinovici N, Guo H, Reeves J, Jiao X, Sandstrom P, Verholen F, Higano CS, Shore N. Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study). Prostate Cancer Prostatic Dis. 2022 Feb;25(2):306-313. doi: 10.1038/s41391-021-00488-0. Epub 2022 Feb 21.
- 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.clinicalstudydatarequest.com 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 Study sponsors 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Bayer at 1 site 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 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Overall survival from initiation of Ra-223 (time frame: Retrospective analysis from Jan 2013 to Dec 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516161, which also lists 1 linked publication.
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 31 Mar 2022.