NCT04516707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 12, 2020

Last Update Submit

August 14, 2020

Conditions

Prostate CancerBone MetastasesHormone-resistant Prostate Cancer

Keywords

xofigoclinical database

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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

  • Collect the causes of premature discontinuation of treatment

    during the treatment of XOFIGO an average of 24 weeks

  • assess the antalgic effet of treatment (number of antalgic taken and how many time)

    during the treatment of XOFIGO an average of 24 weeks

  • assess the overall survival

    during the treatment of XOFIGO an average of 24 weeks

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients expressing a refusal to use this research data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

Location

ICO Bordeaux

Bordeaux, France

Location

UP Clermont Ferrand

Clermont-Ferrand, France

Location

Chu Grenoble

Grenoble, France

Location

IPC Marseille

Marseille, France

Location

CRLC de Nantes

Nantes, France

Location

APHP Hopital Cochin

Paris, France

Location

ONCOLOPE

Toulouse, France

Location

Related Publications (3)

  • 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.

    PMID: 23326203RESULT

  • Nilsson 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.

    PMID: 22341993RESULT

  • Parker 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.

    PMID: 23000088RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Emmanuel DESHAYES, MD

    ICM Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 18, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

May 1, 2018

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)