Metastatic Castration-Resistant Prostate CancerPRECISENCT04256993
PRECISE, a Study to Gather More Information About Bone Fractures and Survival in Castration-resistant PRostate Cancer (CRPC) patiEnts Treated With Radium-223 in Routine Clinical practIce in SwedEn
An observational study of Metastatic Castration-Resistant Prostate Cancer, run by Bayer at 1 site in Sweden.
Trial summary
In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 1,434 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2020to 1 Jun 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises men with mCRPC in the PPC (Patient-overview Prostate Cancer) PCBaSe data set during the study time frame, with the potential addition of men with mCRPC in the Karolinska Institutet data sets.
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).
- Start of Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to 4.
- ECOG performance status of 0-2 at treatment initiation. We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.
Who cannot join
- Prior use of Ra-223
- Patients that have participated in a Ra-223 RCT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn
In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). 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), Other standard care
- Keywords
- Prostate cancer metastatic, Prostate cancer, Bone fractures, Overall survival
- Medical subject headings
- Prostatic Neoplasms, Fractures, Bone
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
Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.
Other standard careDrug
Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Ra-223 initiators | Patients diagnosed with mCRPC (Metastatic Castration-Resistant Prostate Cancer) who start treatment with Ra-223. Patients will be identified from the "Patient-overview Prostate Cancer" (PPC), a sub-registry of the Prostate Cancer data Base Sweden (PCBaSe) data set. Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) | |
| Initiators of other standard of care | The comparator cohort will be patients using standard of care other than Ra-223. Receives: Drug: Other standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
PCBaSe: Prostate Cancer data Base Sweden
Measured: Retrospectively analysis from November 2013 to December 2018
Secondary outcomes (2)
Death due to all causes
Measured: Retrospectively analysis from November 2013 to December 2018
Death due to prostate cancer
Measured: Retrospectively analysis from November 2013 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Feb 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256993
- Sponsor's protocol ID
- 20437
- Acronym
- PRECISE
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2020
- Last updated
- 16 Jan 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.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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn
- ClinicalTrials.gov ID
- NCT04256993
- Acronym / sponsor ID
- PRECISE / 20437
- Keywords
- Prostate cancer metastatic, Prostate cancer, Bone fractures, Overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,434 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Feb 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 bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Ra-223 initiators | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Patients diagnosed with mCRPC (Metastatic Castration-Resistant Prostate Cancer) who start treatment with Ra-223. Patients will be identified from the "Patient-overview Prostate Cancer" (PPC), a sub-registry of the Prostate Cancer data Base Sweden (PCBaSe) data set. |
| Initiators of other standard of care | – | Drug: Other standard careThe comparator cohort will be patients using standard of care other than Ra-223. |
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 comprises men with mCRPC in the PPC (Patient-overview Prostate Cancer) PCBaSe data set during the study time frame, with the potential addition of men with mCRPC in the Karolinska Institutet data sets.
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).
- Start of Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to 4.
- ECOG performance status of 0-2 at treatment initiation. We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.
Key exclusion criteria (2 listed)
- Prior use of Ra-223
- Patients that have participated in a Ra-223 RCT
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)Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs. | Drug | Ra-223 initiators |
| Other standard careDocetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice. | Drug | Initiators of other standard of care |
Primary outcome
Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
Time frame: Retrospectively analysis from November 2013 to December 2018
PCBaSe: Prostate Cancer data Base Sweden
2 secondary outcomes
Death due to all causes
Time frame: Retrospectively analysis from November 2013 to December 2018
Death due to prostate cancer
Time frame: Retrospectively analysis from November 2013 to December 2018
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 16 Jan 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.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, run by Bayer at 1 site in Sweden.
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 3 inclusion and 2 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 16 Jan 2024. 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 Sweden. 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?
Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe (time frame: Retrospectively analysis from November 2013 to December 2018). 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 16 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.