Prostate CancerXOFIGONCT04516707
Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO
An observational study of Prostate Cancer and Bone Metastases, run by Institut du Cancer de Montpellier - Val d'Aurelle at 8 sites in France.
Trial summary
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Bone Metastases, Hormone-resistant Prostate Cancer
- What is being tested?
- clinical database
- How many people
- 67 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Jan 2016to 1 May 2018
- 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: All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
Who may be able to join
- All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
Who cannot join
- Patients expressing a refusal to use this research data
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
ICO Bordeaux
Bordeaux
UP Clermont Ferrand
Clermont-Ferrand
Chu Grenoble
Grenoble
IPC Marseille
Marseille
Icm Val D'Aurelle
Montpellier, Herault, 34298
CRLC de Nantes
Nantes
APHP Hopital Cochin
Paris
ONCOLOPE
Toulouse
About this study
Official title: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.
bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
Read the detailed description
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases.
They frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
There is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
This treatment appears to have fewer side effects than chemotherapy (and does not call into question subsequent chemotherapy) or that the currently available metabolic bone radiotherapy as well as better pain control and survival gain than the latter do not
- Being tested
- clinical database
- Keywords
- xofigo, clinical database
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical databaseOther
The various clinicam database will be collected solely to meet the objectives of the study.
All data collected to create the database for this project will be anonymized
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the epidemiological characteristics of the treated patient population
clinical data collection in the medical record
Measured: during the treatment of XOFIGO an average of 24 weeks
Secondary outcomes (5)
Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment
clinical data collection in the medical record
Measured: during the treatment of XOFIGO an average of 24 weeks
Assess the number of patients who were able to benefit from the complete treatment (6 cycles)
clinical data collection in the medical record
Measured: during the treatment of XOFIGO an average of 24 weeks
Collect the causes of premature discontinuation of treatment
clinical data collection in the medical record
Measured: during the treatment of XOFIGO an average of 24 weeks
assess the antalgic effet of treatment (number of antalgic taken and how many time)
clinical data collection in the medical record
Measured: during the treatment of XOFIGO an average of 24 weeks
assess the overall survival
clinical data collection in the medical record
Measured: during the treatment of XOFIGO an average of 24 weeks
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 start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel DESHAYES, MD, Study chair, ICM Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516707
- Sponsor's protocol ID
- ICM-URC 2015/75
- Acronym
- XOFIGO
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harrison MR, Wong TZ, Armstrong AJ, George DJ. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5:1-14. doi: 10.2147/CMAR.S25537. Epub 2013 Jan 8.
PubMed 23326203Nilsson S, Strang P, Aksnes AK, Franzen L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland OS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15.
PubMed 22341993Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germa JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.
PubMed 23000088
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04516707
- Acronym / sponsor ID
- XOFIGO / ICM-URC 2015/75
- Keywords
- xofigo, clinical database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 May 2018 (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.
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.
bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
Detailed description
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases.
They frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
There is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
This treatment appears to have fewer side effects than chemotherapy (and does not call into question subsequent chemotherapy) or that the currently available metabolic bone radiotherapy as well as better pain control and survival gain than the latter do not
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
Key inclusion criteria (1 listed)
- All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
Key exclusion criteria (1 listed)
- Patients expressing a refusal to use this research data
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 |
|---|---|---|
| clinical databaseThe various clinicam database will be collected solely to meet the objectives of the study. All data collected to create the database for this project will be anonymized | Other | – |
Primary outcome
Assess the epidemiological characteristics of the treated patient population
Time frame: during the treatment of XOFIGO an average of 24 weeks
clinical data collection in the medical record
5 secondary outcomes
Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment
Time frame: during the treatment of XOFIGO an average of 24 weeks
Assess the number of patients who were able to benefit from the complete treatment (6 cycles)
Time frame: during the treatment of XOFIGO an average of 24 weeks
Collect the causes of premature discontinuation of treatment
Time frame: during the treatment of XOFIGO an average of 24 weeks
assess the antalgic effet of treatment (number of antalgic taken and how many time)
Time frame: during the treatment of XOFIGO an average of 24 weeks
assess the overall survival
Time frame: during the treatment of XOFIGO an average of 24 weeks
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 18 Aug 2020.
- Results publication: PubMed 23326203Harrison MR, Wong TZ, Armstrong AJ, George DJ. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5:1-14. doi: 10.2147/CMAR.S25537. Epub 2013 Jan 8.
- Results publication: PubMed 22341993Nilsson S, Strang P, Aksnes AK, Franzen L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland OS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15.
- Results publication: PubMed 23000088Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germa JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.
- Individual participant dataSharing planned: No
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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.
Emmanuel DESHAYES, MD study chair
ICM Val d'Aurelle
8 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 and Bone Metastases, run by Institut du Cancer de Montpellier - Val d'Aurelle at 8 sites in France.
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: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
Assess the epidemiological characteristics of the treated patient population (time frame: during the treatment of XOFIGO an average of 24 weeks). 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 NCT04516707, which also lists 3 linked publications.
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 18 Aug 2020.