Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO (XOFIGO)

August 14, 2020 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • ICO Bordeaux
      • Clermont-Ferrand, France
        • UP Clermont Ferrand
      • Grenoble, France
        • CHU Grenoble
      • Marseille, France
        • IPC Marseille
      • Nantes, France
        • CRLC de Nantes
      • Paris, France
        • APHP Hôpital Cochin
      • Toulouse, France
        • ONCOLOPE
    • Herault
      • Montpellier, Herault, France, 34298
        • Icm Val D'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: during the treatment of XOFIGO an average of 24 weeks
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)
Time Frame: during the treatment of XOFIGO an average of 24 weeks
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
Time Frame: during the treatment of XOFIGO an average of 24 weeks
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)
Time Frame: during the treatment of XOFIGO an average of 24 weeks
clinical data collection in the medical record
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
clinical data collection in the medical record
during the treatment of XOFIGO an average of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Emmanuel DESHAYES, MD, Icm Val D'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-URC 2015/75

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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