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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ferring Arzneimittel GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2009

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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