Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
Conditions
Brief summary
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.
Interventions
OTHERFirmagon given by prescription according to SPC
Non-interventional,observational Firmagon given by prescription according to SPC
Sponsors
Ferring Arzneimittel GmbH
Ferring Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* therapeutic need according to SPC * written informed consent
Exclusion criteria
\- contraindications according to SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of the PSA progression-free survival | open (until therapy end or stop) |
Secondary
| Measure | Time frame |
|---|---|
| 1. testosterone levels | open (until therapy end or stop) |
| 2. number of ADRs and SUSARs | open (until therapy end or stop) |
| 3. quality of life | open (until therapy end or stop) |
Countries
Germany
Outcome results
None listed