Effectiveness and Safety of Firmagon® (FAST)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma |
Other: Firmagon given by prescription according to SPC |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma |
- duration of the PSA progression-free survival [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: No ]
- 1. testosterone levels [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: No ]
- 2. number of ADRs and SUSARs [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: Yes ]
- 3. quality of life [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: No ]
| Enrollment: | 673 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
|
Other: Firmagon given by prescription according to SPC
Non-interventional,observational Firmagon given by prescription according to SPC
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Advanced Hormone-dependent Prostate Carcinoma
Inclusion Criteria:
- therapeutic need according to SPC
- written informed consent
Exclusion Criteria:
- contraindications according to SPC
Contacts and Locations
Show 231 Study Locations| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00930319 History of Changes |
| Other Study ID Numbers: | FE200486 CS41 |
| Study First Received: | June 29, 2009 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Carcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013