Effectiveness and Safety of Firmagon®

Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma Clinical Trial

— FAST  

Official title:

Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930319
• Other study ID #: FE200486 CS41
• Status: Completed
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• therapeutic need according to SPC

• written informed consent

Exclusion Criteria:

• contraindications according to SPC

Related Conditions & MeSH terms

• Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
• Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Firmagon given by prescription according to SPC
Non-interventional,observational Firmagon given by prescription according to SPC

Locations

Country	Name	City	State
Germany	Investigational Site, Heinrich-Rieger-Str. 15	Aalen
Germany	Investigational Site, Weidenfelder Straße 1	Aalen
Germany	Investigational Site	Abensberg
Germany	Investigational Site	Ahaus
Germany	Investigational Site	Ahrensburg
Germany	Investigational Site	Alsdorf
Germany	Investigational Site	Alsfeld
Germany	Investigational Site	Altenburg
Germany	Investigational Site	Andernach
Germany	Investigational Site, Endresstraße 12	Ansbach
Germany	Investigational Site, Platenstraße 15	Ansbach
Germany	Investigational Site, Frölichstraße 13	Augsburg
Germany	Investigational Site, Prinzregentenstraße 4	Augsburg
Germany	Investigational Site	Bad Godesberg
Germany	Investigational Site	Bad Marienberg
Germany	Investigational Site	Bad Oldesloe
Germany	Investigational Site	Bad Salzuflen
Germany	Investigational Site	Bad Schönborn
Germany	Investigational Site	Bad Wildungen
Germany	Investigational Site	Bautzen
Germany	Investigational Site	Bergzabern
Germany	Investigational Site, Albert-Einstein-Straße 2	Berlin
Germany	Investigational Site, Allee der Kosmonauten 47	Berlin
Germany	Investigational Site, Hohenzollerndamm 47a	Berlin
Germany	Investigational Site, Lipschitzallee 20	Berlin
Germany	Investigational Site, Mehrower Allee 22	Berlin
Germany	Investigational Site, Pasteurstraße 8	Berlin
Germany	Investigational Site, Rudolff-Seifert-Straße 11	Berlin
Germany	Investigational Site, Wisbyer Straße 16	Berlin
Germany	Investigational Site, Zeppelinring 7	Biberach
Germany	Investigational Site	Biedenkopf
Germany	Investigational Site, Elbeallee 83	Bielefeld
Germany	Investigational Site, Friedrich-Verleger Straße 5	Bielefeld
Germany	Investigational Site, Johannisstraße 43	Bielefeld
Germany	Investigational Site, Treppenstraße 3	Bielefeld
Germany	Investigational Site	Bitterfeld
Germany	Investigational Site	Bocholt
Germany	Investigational Site, St. Augustiner-Straße 21	Bonn
Germany	Investigational Site, Trierer Straße 70 - 72	Bonn
Germany	Investigational Site	Borken
Germany	Investigational Site	Bramsche
Germany	Investigational Site	Braunschweig
Germany	Investigational Site	Bremen
Germany	Investigational Site, Dr.-Franz-Mertens-Straße 8	Bremerhaven
Germany	Investigational Site, Georgstraße 44	Bremerhaven
Germany	Investigational Site	Bruchköbel
Germany	Investigational Site	Buchholz
Germany	Investigational Site	Bünde
Germany	Investigational Site	Burg
Germany	Investigational Site	Celle
Germany	Investigational Site, Carl-von-Ossietzky-Str. 151	Chemnitz
Germany	Investigational Site, Clausstraße 44	Chemnitz
Germany	Investigational Site, Flemmingstraße 1b	Chemnitz
Germany	Investigational Site, Unritzstraße 21 c	Chemnitz
Germany	Investigational Site	Coburg
Germany	Investigational Site	Cottbus
Germany	Investigational Site, Karlstraße 30	Crailsheim
Germany	Investigational Site, Postplatz 2	Crailsheim
Germany	Investigational Site	Delitzsch
Germany	Investigational Site	Dessau
Germany	Investigational Site	Dessau-Roßlau
Germany	Investigational Site	Dillenburg
Germany	Investigational Site	Dinslaken
Germany	Investigational Site	Dortmund
Germany	Investigational Site	Dossenheim
Germany	Investigational Site	Dresden
Germany	Investigational Site, Königstraße 49	Duisburg
Germany	Investigational Site, Kreuzstraße 3-5	Duisburg
Germany	Investigational Site	Dülmen
Germany	Investigational Site	Düsseldorf
Germany	Investigational Site	Eisenhüttenstadt
Germany	Investigational Site, Geschwister-Scholl-Str. 6	Erfurt
Germany	Investigational Site, Juri-Gagarin-Ring 94	Erfurt
Germany	Investigational Site	Essen
Germany	Investigational Site	Finsterwalde
Germany	Investigational Site, Eschersheimer Landstr. 544	Frankfurt
Germany	Investigational Site, Im Steinbügel 13	Frankfurt
Germany	Investigational Site	Freiburg
Germany	Investigational Site	Freital
Germany	Investigational Site	Friedberg
Germany	Investigational Site	Friedrichshafen
Germany	Investigational Site, Arminstraße 24	Gelsenkirchen
Germany	Investigational Site, Feldmarkstraße 109	Gelsenkirchen
Germany	Investigational Site, Zum Ehrenmal 21	Gelsenkirchen
Germany	Investigational Site	Gera
Germany	Investigational Site	Gießen
Germany	Investigational Site, Helenenstraße 10-12	Gotha
Germany	Investigational Site, Schützenberg 10	Gotha
Germany	Investigational Site	Grimma
Germany	Investigational Site, Niemeyerstraße 23	Halle
Germany	Investigational Site, Reilstraße 129 a	Halle
Germany	Investigational Site, Steinweg 27	Halle (Saale)
Germany	Investigational Site, Alte Holstenstraße 16	Hamburg
Germany	Investigational Site, Fuhlsbüttler Straße 182	Hamburg
Germany	Investigational Site, Grindelberg 3	Hamburg
Germany	Investigational Site, Herthastraße 12	Hamburg
Germany	Investigational Site, Tangstedter Landstraße 77	Hamburg
Germany	Investigational Site	Hattersheim
Germany	Investigational Site	Heidelberg
Germany	Investigational Site	Heilbronn
Germany	Investigational Site	Heinsberg
Germany	Investigational Site	Hennigsdorf
Germany	Investigational Site	Herford
Germany	Investigational Site, Enoch-Widmann-Straße 5	Hof
Germany	Investigational Site, Eppenreuther Straße 28	Hof
Germany	Investigational Site	Isenburg
Germany	Investigational Site	Jena
Germany	Investigational Site	Jülich
Germany	Investigational Site	Kaiserslautern
Germany	Investigational Site	Kamenz
Germany	Investigational Site	Kamp-Lintfort
Germany	Investigational Site	Karlsruhe
Germany	Investigational Site	Kempten
Germany	Investigational Site, Markt 11	Kiel
Germany	Investigational Site, Prüner Gang 15	Kiel
Germany	Investigational Site, Schulstraße 7	Kiel
Germany	Investigational Site	Kleinblittersdorf
Germany	Investigational Site, Custodistraße 3-17	Köln
Germany	Investigational Site, Wilhelm-Ewald-Weg 1	Köln
Germany	Investigational Site, Zeppelinstraße 1	Köln
Germany	Investigational Site, Friederikenstraße 30	Köthen
Germany	Investigational Site, Siebenbrünnenpromenade 6-7	Köthen
Germany	Investigational Site	Krefeld
Germany	Investigational Site	Kulmbach
Germany	Investigational Site	Lampertheim
Germany	Investigational Site	Langenau
Germany	Investigational Site	Lebach
Germany	Investigational Site	Leutkirch
Germany	Investigational Site	Lichtenfels
Germany	Investigational Site	Limbach-Oberfrohna
Germany	Investigational Site	Lübbenau
Germany	Investigational Site	Lübeck
Germany	Investigational Site	Ludwigshafen
Germany	Investigational Site	Lüneburg
Germany	Investigational Site	Lünen
Germany	Investigational Site	Magdeburg
Germany	Investigational Site	Mainz
Germany	Investigational Site, N7, 9	Mannheim
Germany	Investigational Site, Seckenheimer Hauptstraße 107	Mannheim
Germany	Investigational Site	Marburg
Germany	Investigational Site	Marl
Germany	Investigational Site	Mechernich
Germany	Investigational Site	Merseburg
Germany	Investigational Site	Merzig
Germany	Investigational Site	Michelstadt
Germany	Investigational Site	Miltenberg
Germany	Investigational Site	Moers
Germany	Investigational Site	Mölln
Germany	Investigational Site	Mörlenbach
Germany	Investigational Site	Mühlacker
Germany	Investigational Site	Mühlhausen
Germany	Investigational Site	Mühlheim
Germany	Investigational Site, Fürstenbergstraße 5	Münster
Germany	Investigational Site, Hohenzollernring 70	Münster
Germany	Investigational Site	Naumburg
Germany	Investigational Site	Neu-Ulm
Germany	Investigational Site	Neunkirchen
Germany	Investigational Site	Neuss
Germany	Investigational Site	Nienburg
Germany	Investigational Site	Norderstedt
Germany	Investigational Site, Bahnhofstraße 17	Nordhausen
Germany	Investigational Site, Bahnhofstraße 8	Nordhausen
Germany	Investigational Site, Am Museumsturm 4	Nordhorn
Germany	Investigational Site, Osnabrücker Straße 1	Nordhorn
Germany	Investigational Site, Am Stadtpark 2	Nürnberg
Germany	Investigational Site, Hefnersplatz 1	Nürnberg
Germany	Investigational Site, Kopernikusplatz 7	Nürnberg
Germany	Investigational Site	Obernburg
Germany	Investigational Site	Ochsenfurt
Germany	Investigational Site	Offenbach am Main
Germany	Investigational Site	Osnabrück
Germany	Investigational Site	Paderborn
Germany	Investigational Site	Pasewalk
Germany	Investigational Site	Pirna-Copitz
Germany	Investigational Site	Prüm
Germany	Investigational Site	Pulheim
Germany	Investigational Site, Hindenburgstraße 10 A	Rastatt
Germany	Investigational Site, Kaiserstraße 7	Rastatt
Germany	Investigational Site, Gartenstraße 22	Ravensburg
Germany	Investigational Site, Grüner-Turm-Straße 7-9	Ravensburg
Germany	Investigational Site	Regensburg
Germany	Investigational Site	Remscheid
Germany	Investigational Site	Ribnitz-Damgarten
Germany	Investigational Site, Große Wasserstraße 2 - 3	Rostock
Germany	Investigational Site, Nobelstraße 51	Rostock
Germany	Investigational Site, Trelleborger Straße 10B	Rostock
Germany	Investigational Site	Rothenbach an der Pegnitz
Germany	Investigational Site	Rottweil
Germany	Investigational Site, Mainzer Straße 105	Saarbrücken
Germany	Investigational Site, Viktoriastraße 2	Saarbrücken
Germany	Investigational Site	Saarlouis
Germany	Investigational Site	Salzmünde
Germany	Investigational Site	Schönebeck
Germany	Investigational Site	Schwäbisch Gmünd
Germany	Investigational Site	Schwandorf
Germany	Investigational Site	Schwerin
Germany	Investigational Site	Schwerte
Germany	Investigational Site	Senden
Germany	Investigational Site	Sindelfingen
Germany	Investigational Site	Sömmerda
Germany	Investigational Site, Kirchplatz 6a	Spremberg
Germany	Investigational Site, Lustgartenstraße 3	Spremberg
Germany	Investigational Site	Stockelsdorf
Germany	Investigational Site	Stolberg
Germany	Investigational Site	Stuttgart
Germany	Investigational Site	Sulzbach-Rosenberg
Germany	Investigational Site	Tettnang
Germany	Investigational Site	Tostedt
Germany	Investigational Site	Trier
Germany	Investigational Site	Troisdorf
Germany	Investigational Site	Überlingen
Germany	Investigational Site, Hirschstraße 22	Ulm
Germany	Investigational Site, Olgastraße 103	Ulm
Germany	Investigational Site, Olgastraße 139	Ulm
Germany	Investigational Site	Velbert
Germany	Investigational Site	Völklingen
Germany	Investigational Site	VS-Villingen
Germany	Investigational Site	Wangen
Germany	Investigational Site, Moosbürger Str. 13	Weiden
Germany	Investigational Site, Postgasse 1	Weiden
Germany	Investigational Site	Weissenfels
Germany	Investigational Site	Werl
Germany	Investigational Site	Werningerode
Germany	Investigational Site	Wesel
Germany	Investigational Site	Wiesbaden
Germany	Investigational Site	Wilhelmshaven
Germany	Investigational Site, Heinrich-Nordhoff-Straße 49	Wolfsburg
Germany	Investigational Site, Porschestraße 100	Wolfsburg
Germany	Investigational Site	Würselen
Germany	Investigational Site	Xanten
Germany	Investigational Site	Zerbst

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of the PSA progression-free survival		open (until therapy end or stop)
Secondary	1. testosterone levels		open (until therapy end or stop)
Secondary	2. number of ADRs and SUSARs		open (until therapy end or stop)
Secondary	3. quality of life		open (until therapy end or stop)