Effectiveness and Safety of Firmagon® (FAST)

Ferring

Status: Completed

Conditions: Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Treatments: Other: Firmagon given by prescription according to SPC

Study type: Observational

Funder types: Industry

Identifiers

NCT00930319

FE200486 CS41

Details and patient eligibility

About

Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.

Enrollment: 676 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• therapeutic need according to SPC
• written informed consent

Exclusion criteria

• contraindications according to SPC

Trial design

676 participants in 1 patient group

1

Description:

Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC

Treatment:

Other: Firmagon given by prescription according to SPC