Clinical trial NCT04516707: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO
Official title: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Bone Metastases
Hormone-resistant Prostate Cancer
Keywords: xofigo
clinical database
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Assess the epidemiological characteristics of the treated patient population
timeFrame: during the treatment of XOFIGO an average of 24 weeks
Secondary outcomes:
measure: Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment
timeFrame: during the treatment of XOFIGO an average of 24 weeks
measure: Assess the number of patients who were able to benefit from the complete treatment (6 cycles)
timeFrame: during the treatment of XOFIGO an average of 24 weeks
measure: Collect the causes of premature discontinuation of treatment
timeFrame: during the treatment of XOFIGO an average of 24 weeks
measure: assess the antalgic effet of treatment (number of antalgic taken and how many time)
timeFrame: during the treatment of XOFIGO an average of 24 weeks
measure: assess the overall survival
timeFrame: during the treatment of XOFIGO an average of 24 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Icm Val D'Aurelle
state: Herault
city: Bordeaux
country: France
facility: ICO Bordeaux
city: Clermont-Ferrand
country: France
facility: UP Clermont Ferrand
city: Grenoble
country: France
facility: Chu Grenoble
city: Marseille
country: France
facility: IPC Marseille
city: Nantes
country: France
facility: CRLC de Nantes
city: Paris
country: France
facility: APHP Hopital Cochin
city: Toulouse
country: France
facility: ONCOLOPE
Study officials:
affiliation: ICM Val d'Aurelle
name: Emmanuel DESHAYES, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.