NCT04516707

Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2018-05-01
• First posted: 2020-08-18
• Last updated: 2020-08-18

Locations

8 sites across 1 country: France