Effectiveness and Safety of Firmagon® (FAST)

November 8, 2023 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

676

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aalen, Germany
        • Investigational Site, Heinrich-Rieger-Str. 15
      • Aalen, Germany
        • Investigational Site, Weidenfelder Straße 1
      • 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
      • Ansbach, Germany
        • Investigational Site, Endresstraße 12
      • Ansbach, Germany
        • Investigational Site, Platenstraße 15
      • Augsburg, Germany
        • Investigational Site, Frölichstraße 13
      • Augsburg, Germany
        • Investigational Site, Prinzregentenstraße 4
      • 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
      • Berlin, 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
      • Biberach, Germany
        • Investigational Site, Zeppelinring 7
      • Biedenkopf, Germany
        • Investigational Site
      • Bielefeld, 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
      • Bitterfeld, Germany
        • Investigational Site
      • Bocholt, Germany
        • Investigational Site
      • Bonn, Germany
        • Investigational Site, St. Augustiner-Straße 21
      • Bonn, Germany
        • Investigational Site, Trierer Straße 70 - 72
      • Borken, Germany
        • Investigational Site
      • Bramsche, Germany
        • Investigational Site
      • Braunschweig, Germany
        • Investigational Site
      • Bremen, Germany
        • Investigational Site
      • Bremerhaven, Germany
        • Investigational Site, Dr.-Franz-Mertens-Straße 8
      • Bremerhaven, Germany
        • Investigational Site, Georgstraße 44
      • Bruchköbel, Germany
        • Investigational Site
      • Buchholz, Germany
        • Investigational Site
      • Burg, Germany
        • Investigational Site
      • Bünde, Germany
        • Investigational Site
      • Celle, Germany
        • Investigational Site
      • Chemnitz, 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
      • Coburg, Germany
        • Investigational Site
      • Cottbus, Germany
        • Investigational Site
      • Crailsheim, Germany
        • Investigational Site, Karlstraße 30
      • Crailsheim, Germany
        • Investigational Site, Postplatz 2
      • 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
      • Duisburg, Germany
        • Investigational Site, Kreuzstraße 3-5
      • Duisburg, Germany
        • Investigational Site, Königstraße 49
      • Dülmen, Germany
        • Investigational Site
      • Düsseldorf, Germany
        • Investigational Site
      • Eisenhüttenstadt, Germany
        • Investigational Site
      • Erfurt, Germany
        • Investigational Site, Geschwister-Scholl-Str. 6
      • Erfurt, Germany
        • Investigational Site, Juri-Gagarin-Ring 94
      • Essen, Germany
        • Investigational Site
      • Finsterwalde, Germany
        • Investigational Site
      • Frankfurt, Germany
        • Investigational Site, Eschersheimer Landstr. 544
      • Frankfurt, Germany
        • Investigational Site, Im Steinbügel 13
      • Freiburg, Germany
        • Investigational Site
      • Freital, Germany
        • Investigational Site
      • Friedberg, Germany
        • Investigational Site
      • Friedrichshafen, Germany
        • Investigational Site
      • Gelsenkirchen, Germany
        • Investigational Site, Arminstraße 24
      • Gelsenkirchen, Germany
        • Investigational Site, Feldmarkstraße 109
      • Gelsenkirchen, Germany
        • Investigational Site, Zum Ehrenmal 21
      • Gera, Germany
        • Investigational Site
      • Gießen, Germany
        • Investigational Site
      • Gotha, Germany
        • Investigational Site, Helenenstraße 10-12
      • Gotha, Germany
        • Investigational Site, Schützenberg 10
      • Grimma, Germany
        • Investigational Site
      • Halle, Germany
        • Investigational Site, Niemeyerstraße 23
      • Halle, Germany
        • Investigational Site, Reilstraße 129 a
      • Halle (Saale), Germany
        • Investigational Site, Steinweg 27
      • Hamburg, 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
      • Hattersheim, Germany
        • Investigational Site
      • Heidelberg, Germany
        • Investigational Site
      • Heilbronn, Germany
        • Investigational Site
      • Heinsberg, Germany
        • Investigational Site
      • Hennigsdorf, Germany
        • Investigational Site
      • Herford, Germany
        • Investigational Site
      • Hof, Germany
        • Investigational Site, Enoch-Widmann-Straße 5
      • Hof, Germany
        • Investigational Site, Eppenreuther Straße 28
      • 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
      • Kiel, Germany
        • Investigational Site, Markt 11
      • Kiel, Germany
        • Investigational Site, Prüner Gang 15
      • Kiel, Germany
        • Investigational Site, Schulstraße 7
      • Kleinblittersdorf, Germany
        • Investigational Site
      • Krefeld, Germany
        • Investigational Site
      • Kulmbach, Germany
        • Investigational Site
      • Köln, Germany
        • Investigational Site, Custodistraße 3-17
      • Köln, Germany
        • Investigational Site, Wilhelm-Ewald-Weg 1
      • Köln, Germany
        • Investigational Site, Zeppelinstraße 1
      • Köthen, Germany
        • Investigational Site, Friederikenstraße 30
      • Köthen, Germany
        • Investigational Site, Siebenbrünnenpromenade 6-7
      • 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
      • Ludwigshafen, Germany
        • Investigational Site
      • Lübbenau, Germany
        • Investigational Site
      • Lübeck, Germany
        • Investigational Site
      • Lüneburg, Germany
        • Investigational Site
      • Lünen, Germany
        • Investigational Site
      • Magdeburg, Germany
        • Investigational Site
      • Mainz, Germany
        • Investigational Site
      • Mannheim, Germany
        • Investigational Site, N7, 9
      • Mannheim, Germany
        • Investigational Site, Seckenheimer Hauptstraße 107
      • 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
      • Münster, Germany
        • Investigational Site, Fürstenbergstraße 5
      • Münster, Germany
        • Investigational Site, Hohenzollernring 70
      • 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
      • Nordhausen, Germany
        • Investigational Site, Bahnhofstraße 17
      • Nordhausen, Germany
        • Investigational Site, Bahnhofstraße 8
      • Nordhorn, Germany
        • Investigational Site, Am Museumsturm 4
      • Nordhorn, Germany
        • Investigational Site, Osnabrücker Straße 1
      • Nürnberg, Germany
        • Investigational Site, Am Stadtpark 2
      • Nürnberg, Germany
        • Investigational Site, Hefnersplatz 1
      • Nürnberg, Germany
        • Investigational Site, Kopernikusplatz 7
      • 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
      • Rastatt, Germany
        • Investigational Site, Hindenburgstraße 10 A
      • Rastatt, Germany
        • Investigational Site, Kaiserstraße 7
      • Ravensburg, Germany
        • Investigational Site, Gartenstraße 22
      • Ravensburg, Germany
        • Investigational Site, Grüner-Turm-Straße 7-9
      • Regensburg, Germany
        • Investigational Site
      • Remscheid, Germany
        • Investigational Site
      • Ribnitz-Damgarten, Germany
        • Investigational Site
      • Rostock, Germany
        • Investigational Site, Große Wasserstraße 2 - 3
      • Rostock, Germany
        • Investigational Site, Nobelstraße 51
      • Rostock, Germany
        • Investigational Site, Trelleborger Straße 10B
      • Rothenbach an der Pegnitz, Germany
        • Investigational Site
      • Rottweil, Germany
        • Investigational Site
      • Saarbrücken, Germany
        • Investigational Site, Mainzer Straße 105
      • Saarbrücken, Germany
        • Investigational Site, Viktoriastraße 2
      • Saarlouis, Germany
        • Investigational Site
      • Salzmünde, Germany
        • Investigational Site
      • Schwandorf, Germany
        • Investigational Site
      • Schwerin, Germany
        • Investigational Site
      • Schwerte, Germany
        • Investigational Site
      • Schwäbisch Gmünd, Germany
        • Investigational Site
      • Schönebeck, Germany
        • Investigational Site
      • Senden, Germany
        • Investigational Site
      • Sindelfingen, Germany
        • Investigational Site
      • Spremberg, Germany
        • Investigational Site, Kirchplatz 6a
      • Spremberg, Germany
        • Investigational Site, Lustgartenstraße 3
      • Stockelsdorf, Germany
        • Investigational Site
      • Stolberg, Germany
        • Investigational Site
      • Stuttgart, Germany
        • Investigational Site
      • Sulzbach-Rosenberg, Germany
        • Investigational Site
      • Sömmerda, Germany
        • Investigational Site
      • Tettnang, Germany
        • Investigational Site
      • Tostedt, Germany
        • Investigational Site
      • Trier, Germany
        • Investigational Site
      • Troisdorf, Germany
        • Investigational Site
      • Ulm, Germany
        • Investigational Site, Hirschstraße 22
      • Ulm, Germany
        • Investigational Site, Olgastraße 103
      • Ulm, Germany
        • Investigational Site, Olgastraße 139
      • VS-Villingen, Germany
        • Investigational Site
      • Velbert, Germany
        • Investigational Site
      • Völklingen, Germany
        • Investigational Site
      • Wangen, Germany
        • Investigational Site
      • Weiden, Germany
        • Investigational Site, Moosbürger Str. 13
      • Weiden, Germany
        • Investigational Site, Postgasse 1
      • Weissenfels, Germany
        • Investigational Site
      • Werl, Germany
        • Investigational Site
      • Werningerode, Germany
        • Investigational Site
      • Wesel, Germany
        • Investigational Site
      • Wiesbaden, Germany
        • Investigational Site
      • Wilhelmshaven, Germany
        • Investigational Site
      • Wolfsburg, Germany
        • Investigational Site, Heinrich-Nordhoff-Straße 49
      • Wolfsburg, Germany
        • Investigational Site, Porschestraße 100
      • Würselen, Germany
        • Investigational Site
      • Xanten, Germany
        • Investigational Site
      • Zerbst, Germany
        • Investigational Site
      • Überlingen, Germany
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Advanced Hormone-dependent Prostate Carcinoma

Description

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

- contraindications according to SPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of the PSA progression-free survival
Time Frame: open (until therapy end or stop)
open (until therapy end or stop)

Secondary Outcome Measures

Outcome Measure
Time Frame
1. testosterone levels
Time Frame: open (until therapy end or stop)
open (until therapy end or stop)
2. number of ADRs and SUSARs
Time Frame: open (until therapy end or stop)
open (until therapy end or stop)
3. quality of life
Time Frame: open (until therapy end or stop)
open (until therapy end or stop)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring Arzneimittel GmbH

Investigators

  • Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimated)

June 30, 2009

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

3
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