Effectiveness and Safety of Firmagon®
- Conditions
- Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
- Interventions
- Other: Firmagon given by prescription according to SPC
- Registration Number
- NCT00930319
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 676
- therapeutic need according to SPC
- written informed consent
- contraindications according to SPC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Firmagon given by prescription according to SPC Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
- Primary Outcome Measures
Name Time Method duration of the PSA progression-free survival open (until therapy end or stop)
- Secondary Outcome Measures
Name Time Method 3. quality of life open (until therapy end or stop) 2. number of ADRs and SUSARs open (until therapy end or stop) 1. testosterone levels open (until therapy end or stop)
Trial Locations
- Locations (88)
Investigational Site, Hohenzollerndamm 47a
🇩🇪Berlin, Germany
Investigational Site, Albert-Einstein-Straße 2
🇩🇪Berlin, Germany
Investigational Site, Reilstraße 129 a
🇩🇪Halle, Germany
Investigational Site, Alte Holstenstraße 16
🇩🇪Hamburg, Germany
Investigational Site, Heinrich-Rieger-Str. 15
🇩🇪Aalen, Germany
Investigational Site, Mehrower Allee 22
🇩🇪Berlin, Germany
Investigational Site, Helenenstraße 10-12
🇩🇪Gotha, Germany
Investigational Site, Am Museumsturm 4
🇩🇪Nordhorn, Germany
Investigational Site, Treppenstraße 3
🇩🇪Bielefeld, Germany
Investigational Site, Steinweg 27
🇩🇪Halle (Saale), Germany
Investigational Site, Zeppelinstraße 1
🇩🇪Köln, Germany
Investigational Site, Custodistraße 3-17
🇩🇪Köln, Germany
Investigational Site, Hohenzollernring 70
🇩🇪Münster, Germany
Investigational Site, Am Stadtpark 2
🇩🇪Nürnberg, Germany
Investigational Site, Moosbürger Str. 13
🇩🇪Weiden, Germany
Investigational Site, Lustgartenstraße 3
🇩🇪Spremberg, Germany
Investigational Site, Kopernikusplatz 7
🇩🇪Nürnberg, Germany
Investigational Site, Hirschstraße 22
🇩🇪Ulm, Germany
Investigational Site, Postgasse 1
🇩🇪Weiden, Germany
Investigational Site, Friederikenstraße 30
🇩🇪Köthen, Germany
Investigational Site, Osnabrücker Straße 1
🇩🇪Nordhorn, Germany
Investigational Site, Hefnersplatz 1
🇩🇪Nürnberg, Germany
Investigational Site, Niemeyerstraße 23
🇩🇪Halle, Germany
Investigational Site, Im Steinbügel 13
🇩🇪Frankfurt, Germany
Investigational Site, Siebenbrünnenpromenade 6-7
🇩🇪Köthen, Germany
Investigational Site, Kaiserstraße 7
🇩🇪Rastatt, Germany
Investigational Site, Seckenheimer Hauptstraße 107
🇩🇪Mannheim, Germany
Investigational Site, N7, 9
🇩🇪Mannheim, Germany
Investigational Site, Fürstenbergstraße 5
🇩🇪Münster, Germany
Investigational Site, Carl-von-Ossietzky-Str. 151
🇩🇪Chemnitz, Germany
Investigational Site, Prüner Gang 15
🇩🇪Kiel, Germany
Investigational Site, Schulstraße 7
🇩🇪Kiel, Germany
Investigational Site, Eppenreuther Straße 28
🇩🇪Hof, Germany
Investigational Site, Johannisstraße 43
🇩🇪Bielefeld, Germany
Investigational Site, Friedrich-Verleger Straße 5
🇩🇪Bielefeld, Germany
Investigational Site, Postplatz 2
🇩🇪Crailsheim, Germany
Investigational Site, Arminstraße 24
🇩🇪Gelsenkirchen, Germany
Investigational Site, Nobelstraße 51
🇩🇪Rostock, Germany
Investigational Site, Mainzer Straße 105
🇩🇪Saarbrücken, Germany
Investigational Site, Olgastraße 139
🇩🇪Ulm, Germany
Investigational Site, Kreuzstraße 3-5
🇩🇪Duisburg, Germany
Investigational Site, Geschwister-Scholl-Str. 6
🇩🇪Erfurt, Germany
Investigational Site, Markt 11
🇩🇪Kiel, Germany
Investigational Site, Wilhelm-Ewald-Weg 1
🇩🇪Köln, Germany
Investigational Site, Grüner-Turm-Straße 7-9
🇩🇪Ravensburg, Germany
Investigational Site, Bahnhofstraße 17
🇩🇪Nordhausen, Germany
Investigational Site, Viktoriastraße 2
🇩🇪Saarbrücken, Germany
Investigational Site, Bahnhofstraße 8
🇩🇪Nordhausen, Germany
Investigational Site, Hindenburgstraße 10 A
🇩🇪Rastatt, Germany
Investigational Site, Heinrich-Nordhoff-Straße 49
🇩🇪Wolfsburg, Germany
Investigational Site, Gartenstraße 22
🇩🇪Ravensburg, Germany
Investigational Site, Große Wasserstraße 2 - 3
🇩🇪Rostock, Germany
Investigational Site, Kirchplatz 6a
🇩🇪Spremberg, Germany
Investigational Site, Olgastraße 103
🇩🇪Ulm, Germany
Investigational Site, Trelleborger Straße 10B
🇩🇪Rostock, Germany
Investigational Site, Porschestraße 100
🇩🇪Wolfsburg, Germany
Investigational Site, Rudolff-Seifert-Straße 11
🇩🇪Berlin, Germany
Investigational Site, Weidenfelder Straße 1
🇩🇪Aalen, Germany
Investigational Site
🇩🇪Überlingen, Germany
Investigational Site, Endresstraße 12
🇩🇪Ansbach, Germany
Investigational Site, Platenstraße 15
🇩🇪Ansbach, Germany
Investigational Site, Allee der Kosmonauten 47
🇩🇪Berlin, Germany
Investigational Site, Frölichstraße 13
🇩🇪Augsburg, Germany
Investigational Site, Prinzregentenstraße 4
🇩🇪Augsburg, Germany
Investigational Site, Lipschitzallee 20
🇩🇪Berlin, Germany
Investigational Site, Pasteurstraße 8
🇩🇪Berlin, Germany
Investigational Site, Elbeallee 83
🇩🇪Bielefeld, Germany
Investigational Site, Wisbyer Straße 16
🇩🇪Berlin, Germany
Investigational Site, Zeppelinring 7
🇩🇪Biberach, Germany
Investigational Site, Trierer Straße 70 - 72
🇩🇪Bonn, Germany
Investigational Site, St. Augustiner-Straße 21
🇩🇪Bonn, Germany
Investigational Site, Dr.-Franz-Mertens-Straße 8
🇩🇪Bremerhaven, Germany
Investigational Site, Georgstraße 44
🇩🇪Bremerhaven, Germany
Investigational Site, Flemmingstraße 1b
🇩🇪Chemnitz, Germany
Investigational Site, Clausstraße 44
🇩🇪Chemnitz, Germany
Investigational Site, Unritzstraße 21 c
🇩🇪Chemnitz, Germany
Investigational Site, Karlstraße 30
🇩🇪Crailsheim, Germany
Investigational Site, Königstraße 49
🇩🇪Duisburg, Germany
Investigational Site, Juri-Gagarin-Ring 94
🇩🇪Erfurt, Germany
Investigational Site, Eschersheimer Landstr. 544
🇩🇪Frankfurt, Germany
Investigational Site, Schützenberg 10
🇩🇪Gotha, Germany
Investigational Site, Feldmarkstraße 109
🇩🇪Gelsenkirchen, Germany
Investigational Site, Zum Ehrenmal 21
🇩🇪Gelsenkirchen, Germany
Investigational Site, Fuhlsbüttler Straße 182
🇩🇪Hamburg, Germany
Investigational Site, Herthastraße 12
🇩🇪Hamburg, Germany
Investigational Site, Grindelberg 3
🇩🇪Hamburg, Germany
Investigational Site, Tangstedter Landstraße 77
🇩🇪Hamburg, Germany
Investigational Site, Enoch-Widmann-Straße 5
🇩🇪Hof, Germany