Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer

Conditions
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Prostate Cancer, Bone Metastases, Hormone-resistant Prostate Cancer

Intervention / Treatment
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* Other: clinical database


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the epidemiological characteristics of the treated patient population | clinical data collection in the medical record | during the treatment of XOFIGO an average of 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment | clinical data collection in the medical record | 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 | 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 | 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 | during the treatment of XOFIGO an average of 24 weeks | 
| assess the overall survival | clinical data collection in the medical record | during the treatment of XOFIGO an average of 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xofigo, clinical database