Effectiveness and Safety of Firmagon®
FAST
1 other identifier
observational
676
1 country
230
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Longer than P75 for all trials
230 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 9, 2023
March 1, 2014
4.5 years
June 29, 2009
November 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
duration of the PSA progression-free survival
open (until therapy end or stop)
Secondary Outcomes (3)
1. testosterone levels
open (until therapy end or stop)
2. number of ADRs and SUSARs
open (until therapy end or stop)
3. quality of life
open (until therapy end or stop)
Study Arms (1)
1
Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
Interventions
Non-interventional,observational Firmagon given by prescription according to SPC
Eligibility Criteria
Patients with Advanced Hormone-dependent Prostate Carcinoma
You may qualify if:
- therapeutic need according to SPC
- written informed consent
You may not qualify if:
- \- contraindications according to SPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Ferring Arzneimittel GmbHcollaborator
Study Sites (230)
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 Bergzaben, 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, 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-Wolfen, 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
Burg, Germany
Investigational Site
Bünde, 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, Custodistraße 3-17
Cologne, Germany
Investigational Site, Wilhelm-Ewald-Weg 1
Cologne, Germany
Investigational Site, Zeppelinstraße 1
Cologne, Germany
Investigational Site
Cottbus, Germany
Investigational Site, Karlstraße 30
Crailsheim, Germany
Investigational Site, Postplatz 2
Crailsheim, Germany
Investigational Site
Delitzsch, Germany
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Dessau, Germany
Investigational Site
Dillenburg, Germany
Investigational Site
Dinslaken, Germany
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Dortmund, Germany
Investigational Site
Dossenheim, Germany
Investigational Site
Dresden, Germany
Investigational Site, Kreuzstraße 3-5
Duisburg, Germany
Investigational Site, Königstraße 49
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 im Breisgau, 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, 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, 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
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Lichtenfels, Germany
Investigational Site
Limbach-Oberfrohna, Germany
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Lubnjow, Germany
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Ludwigshafen, Germany
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Lübeck, Germany
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Lüneburg, Germany
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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
Nuremberg, Germany
Investigational Site, Hefnersplatz 1
Nuremberg, Germany
Investigational Site, Kopernikusplatz 7
Nuremberg, Germany
Investigational Site
Obernburg, Germany
Investigational Site
Ochsenfurt, Germany
Investigational Site
Offenbach, 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
Rottweil, Germany
Investigational Site
Röthenbach an der Pegnitz, 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
Schwandorf in Bayern, Germany
Investigational Site
Schwäbisch Gmünd, 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, Hirschstraße 22
Ulm, Germany
Investigational Site, Olgastraße 103
Ulm, Germany
Investigational Site, Olgastraße 139
Ulm, Germany
Investigational Site
Überlingen, 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, Germany
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 9, 2023
Record last verified: 2014-03