Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina

Ferring Pharmaceuticals90 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Hormone Dependent Prostate Cancer

Interventions

Firmagon® (degarelix)DRUG

Monthly subcutaneous injections

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de Trauma y Emergencia Dr Federico Abete

Ingeniero Pablo Nogués, Buenos Aires, Argentina

Outcomes

Primary Outcomes

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)

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)

Time frame: During 3 years treatment

Data from ClinicalTrials.gov

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