Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Other)
• Overall Status: Completed
• CT.gov ID: NCT04516707
• Collaborator: (none)
• Enrollment: 67
• Locations: 8
• Actual Duration (Months): 28
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Bone Metastases; Hormone-resistant Prostate Cancer	Other: clinical database

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 Design

• Study Type: Observational
• Actual Enrollment: 67 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: May 1, 2018

Outcome Measures

Primary Outcome Measures

1. Assess the epidemiological characteristics of the treated patient population [during the treatment of XOFIGO an average of 24 weeks]

   clinical data collection in the medical record

Secondary Outcome Measures

1. 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]

   clinical data collection in the medical record

2. 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]

   clinical data collection in the medical record

3. Collect the causes of premature discontinuation of treatment [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) [during the treatment of XOFIGO an average of 24 weeks]

   clinical data collection in the medical record

5. assess the overall survival [during the treatment of XOFIGO an average of 24 weeks]

   clinical data collection in the medical record

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icm Val D'Aurelle	Montpellier	Herault	France	34298
2	ICO Bordeaux	Bordeaux		France
3	UP Clermont Ferrand	Clermont-Ferrand		France
4	Chu Grenoble	Grenoble		France
5	IPC Marseille	Marseille		France
6	CRLC de Nantes	Nantes		France
7	APHP Hopital Cochin	Paris		France
8	ONCOLOPE	Toulouse		France

Sponsors and Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

• Study Chair: Emmanuel DESHAYES, MD, ICM Val d'Aurelle

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
• ClinicalTrials.gov Identifier: NCT04516707
• Other Study ID Numbers: ICM-URC 2015/75
• First Posted: Aug 18, 2020
• Last Update Posted: Aug 18, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle: xofigo; clinical database
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Aug 18, 2020