Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

Prostate Cancer Clinical Trial

— XOFIGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516707
• Other study ID #: ICM-URC 2015/75
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2020
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 1, 2018
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Hormone-resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	ICO Bordeaux	Bordeaux
France	UP Clermont Ferrand	Clermont-Ferrand
France	Chu Grenoble	Grenoble
France	IPC Marseille	Marseille
France	Icm Val D'Aurelle	Montpellier	Herault
France	CRLC de Nantes	Nantes
France	APHP Hopital Cochin	Paris
France	ONCOLOPE	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Nilsson S, Strang P, Aksnes AK, Franzèn L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland ØS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients wi — View Citation

Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germá 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 prost — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	assess the overall survival	clinical data collection in the medical record	during the treatment of XOFIGO an average of 24 weeks