Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer

Completed

• Conditions: Advanced Hormone Sensitive Prostate Cancer
• Interventions: Drug: degarelix

• Registration Number: NCT02229253
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-08-28
• Study Start: 2014-09
• Study First Posted: 2014-09-01
• Primary Completion: 2017-10-04
• Study Completion: 2017-10-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 112

Inclusion Criteria

• Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer

Exclusion Criteria

• Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded
• Planned intermittent or short-term (< 12 months) degarelix treatment
• Planned addition of, or switch to another form of androgen deprivation therapy during the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Degarelix	degarelix	Treatment according to standard clinical practice.

Primary Outcome Measures

Name	Time	Method
Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice	Up to 1 year

Trial Locations

Locations (1)

Groene Hart Ziekenhuis (there may be other sites in this country); 🇳🇱 Gouda, Netherlands