Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina
Completed
- Conditions
- Advanced Hormone Dependent Prostate Cancer
- Interventions
- Registration Number
- NCT01861236
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Prospective, observational study to collect and analyze data on patients with advanced hormone dependent prostate cancer treated with Firmagon® according to routine medical practice in Argentina
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 90
Inclusion Criteria
- Advanced Prostate Cancer patients to be treated with Firmagon in the context of usual clinical practice
- Written informed consent
Exclusion Criteria
- Contraindications to Firmagon
- Patients already on Firmagon therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Advanced Prostate Cancer Firmagon® (degarelix) Advanced Prostate Cancer that receive Firmagon therapy in the context of usual clinical practice
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) failure rate (with failure defined as either prostate-specific antigen (PSA) failure, introduction of additional therapy related to prostate cancer, or death) During 3 years treatment The PFS failure rate will be estimated with time to PFS failure as dependent and adjusting for disease stage at baseline, baseline PSA, baseline testosterone (if available) and baseline serum Alkaline Phosphatase (s-ALP, if available)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Trauma y Emergencia Dr Federico Abete
🇦🇷Ingeniero Pablo Nogués, Buenos Aires, Argentina