Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix
- Registration Number
- NCT03193645
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
The DUO study's main objective is to evaluate, in the real life, the prevalence of cardiovascular risk in patients with prostate cancer that hormone treatment of androgen suppression by Degarelix was introduced.
This study will also assess, at the initiation of therapy, the prevalence of osteoporosis, metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 150
Inclusion Criteria
- Male aged 18 years or older
- Diagnosed with prostate cancer
- Patient having received an antagonist of GnRH Degarelix prescription.
- Agreeing to and capable of completing in French during the visits all questionnaires on the impact of their illness and treatment.
- Patients having received oral and written study information, agreeing to the use of his anonymized data, and having signed a written Informed Consent Form.
Exclusion Criteria
- Patient included in an interventional study assessing treatment for prostate cancer.
- Patient presenting hypersensitivity to Degarelix or one of its excipients.
- Patient treated by other hormonotherapy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Degarelix Degarelix -
- Primary Outcome Measures
Name Time Method Occurrence of cardiovascular comorbidity At inclusion Measured by a history of at least one cardiovascular illness (according to ICD-10) and/or at least three cardiovascular risk factors (as defined by Cancer Committee of the French Urology Association)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hopital de la Source (there may be multiple sites in this country)
🇫🇷Orléans, France