Prostatic Neoplasms, Castration-ResistantBELFIGONCT03563014
A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in Belgium.
Trial summary
The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- What is being tested?
- Radium-223 (Xofigo, Bay88-8223)
- How many people
- 164 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jul 2018to 31 Jan 2019
- 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: Belgian patients who were treated with Radium-223 for (metastatic) Castration Resistant Prostate Cancer
Who may be able to join
- Patients with a diagnosis of castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases
- All consecutive patients who started Radium-223 treatment between 22 December 2014 and 01 June 2017
- Availability of medical records during the observation period (22DEC2013 - 01JUN2018)
Who cannot join
- Patients treated with Radium-223 for any reason before 22 December 2014 (for example an interventional trial)
- Patients participated in an investigational program with interventions outside of routine clinical practice during the radium-223 treatment period
- Patients received other radiopharmaceuticals for the systemic concomitant use for treatment of prostate cancer or for other use during the Radium-223 treatment period
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.
- Being tested
- Radium-223 (Xofigo, Bay88-8223)
- Keywords
- Radium-223, Metastatic castration-resistant prostate cancer, CRPC, Phase IV
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 (Xofigo, Bay88-8223)Drug
Follow the physician's prescription in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 (Xofigo, Bay88-8223) | Belgium patients with a diagnosis of mCRPC (no known visceral metastases) and who were treated with Radium-223 for this indication Receives: Drug: Radium-223 (Xofigo, Bay88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary outcomes (13)
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections by Radium-223 line of treatment (1st, 2nd and further line)
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of prior and post life prolonging systemic anti-cancer therapies will be described
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The characteristics of patients according to the experience of the study centers with Radium-223
By stratification according to the number of months after the very first index date per center
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The occurrence of progression post first dose of Radium-223
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The occurrence of SSE related hospitalizations
SSE: Symptomatic Skeletal Events
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The frequency of SSE related hospitalizations
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of discontinuation of Radium-223
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The frequency of blood transfusions
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The overall survival in routine clinical practice
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The timing of progression post first dose of Radium-223
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The time between last Radium-223 injection and next line of systemic anti-cancer therapy
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of patients receiving next line of systemic anti-cancer therapy
Measured: Retrospectively analysis from 22 December 2013 to 01 June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start31 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563014
- Sponsor's protocol ID
- 20239
- Acronym
- BELFIGO
- Status last verified
- May 2020
- First submitted
- 24 May 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
- ClinicalTrials.gov ID
- NCT03563014
- Acronym / sponsor ID
- BELFIGO / 20239
- Keywords
- Radium-223, Metastatic castration-resistant prostate cancer, CRPC, Phase IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Jun 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.
The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 (Xofigo, Bay88-8223) | – | Drug: Radium-223 (Xofigo, Bay88-8223)Belgium patients with a diagnosis of mCRPC (no known visceral metastases) and who were treated with Radium-223 for this indication |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Belgian patients who were treated with Radium-223 for (metastatic) Castration Resistant Prostate Cancer
Key inclusion criteria (3 listed)
- Patients with a diagnosis of castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases
- All consecutive patients who started Radium-223 treatment between 22 December 2014 and 01 June 2017
- Availability of medical records during the observation period (22DEC2013 - 01JUN2018)
Key exclusion criteria (3 listed)
- Patients treated with Radium-223 for any reason before 22 December 2014 (for example an interventional trial)
- Patients participated in an investigational program with interventions outside of routine clinical practice during the radium-223 treatment period
- Patients received other radiopharmaceuticals for the systemic concomitant use for treatment of prostate cancer or for other use during the Radium-223 treatment 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 (Xofigo, Bay88-8223)Follow the physician's prescription in routine clinical practice. | Drug | Radium-223 (Xofigo, Bay88-8223) |
Primary outcome
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
13 secondary outcomes
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections by Radium-223 line of treatment (1st, 2nd and further line)
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of prior and post life prolonging systemic anti-cancer therapies will be described
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The characteristics of patients according to the experience of the study centers with Radium-223
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The occurrence of progression post first dose of Radium-223
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The occurrence of SSE related hospitalizations
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The frequency of SSE related hospitalizations
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of discontinuation of Radium-223
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The frequency of blood transfusions
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The overall survival in routine clinical practice
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The timing of progression post first dose of Radium-223
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The time between last Radium-223 injection and next line of systemic anti-cancer therapy
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of patients receiving next line of systemic anti-cancer therapy
Time frame: Retrospectively analysis from 22 December 2013 to 01 June 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 20 May 2020.
Related trials for Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
Active, not recruitingPhase 1
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 1
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
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 Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in Belgium.
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 3 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 20 May 2020. 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 Belgium. 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 with 5-6 Radium-223 injections versus 1-4 Radium-223 injections (time frame: Retrospectively analysis from 22 December 2013 to 01 June 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 20 May 2020.