Effectiveness and Safety of Firmagon®
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...
Brief Summary
Official Title: “Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma”
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.
- Study Type: Observational
- Study Design: Observational Model: Case-Only, Time Perspective: Prospective
- Study Primary Completion Date: May 2014
Intervention(s) in this Clinical Trial
- Other: Firmagon given by prescription according to SPC
- Non-interventional,observational Firmagon given by prescription according to SPC
Arms, Groups and Cohorts in this Clinical Trial
- : 1
- Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
Outcome Measures for this Clinical Trial
Primary Measures
- duration of the PSA progression-free survival
- Time Frame: open (until therapy end or stop)
Safety Issue?: No
- Time Frame: open (until therapy end or stop)
Secondary Measures
- 1. testosterone levels
- Time Frame: open (until therapy end or stop)
Safety Issue?: No
- Time Frame: open (until therapy end or stop)
- 2. number of ADRs and SUSARs
- Time Frame: open (until therapy end or stop)
Safety Issue?: Yes
- Time Frame: open (until therapy end or stop)
- 3. quality of life
- Time Frame: open (until therapy end or stop)
Safety Issue?: No
- Time Frame: open (until therapy end or stop)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- therapeutic need according to SPC
- written informed consent
Exclusion Criteria:
- contraindications according to SPC
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Ferring Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Clinical Development Support Study Director Ferring Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930319
Study ID Number: FE200486 CS41
ClinicalTrials.gov Identifier: NCT00930319
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00930319
