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Completed

NCT Number: NCT04516707

Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icm Val D'Aurelle, Montpellier, Herault, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical database

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    clinical data collection in the medical record

  2. 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

    clinical data collection in the medical record

  3. Collect the causes of premature discontinuation of treatment

    Time frame: during the treatment of XOFIGO an average of 24 weeks

    clinical data collection in the medical record

  4. 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

    clinical data collection in the medical record

  5. assess the overall survival

    Time frame: during the treatment of XOFIGO an average of 24 weeks

    clinical data collection in the medical record

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: XOFIGO

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 18, 2020
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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