Bone Metastases, Hormone-resistant Prostate Cancer, Prostate Cancer
Conditions
Keywords
xofigo, clinical database
Brief 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. 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
Interventions
OTHERclinical database
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
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
Exclusion criteria
Patients expressing a refusal to use this research data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the epidemiological characteristics of the treated patient population | during the treatment of XOFIGO an average of 24 weeks | clinical data collection in the medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment | during the treatment of XOFIGO an average of 24 weeks | clinical data collection in the medical record |
| Assess the number of patients who were able to benefit from the complete treatment (6 cycles) | during the treatment of XOFIGO an average of 24 weeks | clinical data collection in the medical record |
| Collect the causes of premature discontinuation of treatment | during the treatment of XOFIGO an average of 24 weeks | clinical data collection in the medical record |
| assess the antalgic effet of treatment (number of antalgic taken and how many time) | during the treatment of XOFIGO an average of 24 weeks | clinical data collection in the medical record |
| assess the overall survival | during the treatment of XOFIGO an average of 24 weeks | clinical data collection in the medical record |
Countries
France
Outcome results
None listed