Clinical trial NCT00930319: Effectiveness and Safety of Firmagon®
Official title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2009-06-30
Enrollment: 676
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Advanced Hormone-dependent Prostate Carcinoma

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.


Eligibility criteria: Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

- contraindications according to SPC

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