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Androgen Ablative Therapy of Advanced Hormone-dependent Prostate CarcinomaFASTNCT00930319

Effectiveness and Safety of Firmagon®

An observational study of Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma, run by Ferring Pharmaceuticals at 230 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Firmagon given by prescription according to SPC
How many people
676 participants
Where
230 sitesGermany
Study dates
Jun 2009to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Advanced Hormone-dependent Prostate Carcinoma

Who may be able to join

  • therapeutic need according to SPC
  • written informed consent

Who cannot join

  • contraindications according to SPC

Trial locations and contacts

230 sites in 1 country.

230 sites in 1 country

Germany230 sites

  • Investigational Site, Heinrich-Rieger-Str. 15

    Aalen

  • Investigational Site, Weidenfelder Straße 1

    Aalen

  • Investigational Site

    Abensberg

  • Investigational Site

    Ahaus

  • Investigational Site

    Ahrensburg

  • Investigational Site

    Alsdorf

  • Investigational Site

    Alsfeld

  • Investigational Site

    Altenburg

  • Investigational Site

    Andernach

  • Investigational Site, Endresstraße 12

    Ansbach

  • Investigational Site, Platenstraße 15

    Ansbach

  • Investigational Site, Frölichstraße 13

    Augsburg

  • Investigational Site, Prinzregentenstraße 4

    Augsburg

  • Investigational Site

    Bad Bergzaben

  • Investigational Site

    Bad Godesberg

  • Investigational Site

    Bad Marienberg

  • Investigational Site

    Bad Oldesloe

  • Investigational Site

    Bad Salzuflen

  • Investigational Site

    Bad Schönborn

  • Investigational Site

    Bad Wildungen

  • Investigational Site

    Bautzen

  • Investigational Site, Albert-Einstein-Straße 2

    Berlin

  • Investigational Site, Allee der Kosmonauten 47

    Berlin

  • Investigational Site, Hohenzollerndamm 47a

    Berlin

  • Investigational Site, Lipschitzallee 20

    Berlin

  • Investigational Site, Mehrower Allee 22

    Berlin

  • Investigational Site, Pasteurstraße 8

    Berlin

  • Investigational Site, Rudolff-Seifert-Straße 11

    Berlin

  • Investigational Site, Wisbyer Straße 16

    Berlin

  • Investigational Site, Zeppelinring 7

    Biberach

  • Investigational Site

    Biedenkopf

  • Investigational Site, Elbeallee 83

    Bielefeld

  • Investigational Site, Friedrich-Verleger Straße 5

    Bielefeld

  • Investigational Site, Johannisstraße 43

    Bielefeld

  • Investigational Site, Treppenstraße 3

    Bielefeld

  • Investigational Site

    Bitterfeld-Wolfen

  • Investigational Site

    Bocholt

  • Investigational Site, St. Augustiner-Straße 21

    Bonn

  • Investigational Site, Trierer Straße 70 - 72

    Bonn

  • Investigational Site

    Borken

  • Investigational Site

    Bramsche

  • Investigational Site

    Braunschweig

  • Investigational Site

    Bremen

  • Investigational Site, Dr.-Franz-Mertens-Straße 8

    Bremerhaven

  • Investigational Site, Georgstraße 44

    Bremerhaven

  • Investigational Site

    Bruchköbel

  • Investigational Site

    Buchholz

  • Investigational Site

    Bünde

  • Investigational Site

    Burg

  • Investigational Site

    Celle

  • Investigational Site, Carl-von-Ossietzky-Str. 151

    Chemnitz

  • Investigational Site, Clausstraße 44

    Chemnitz

  • Investigational Site, Flemmingstraße 1b

    Chemnitz

  • Investigational Site, Unritzstraße 21 c

    Chemnitz

  • Investigational Site

    Coburg

  • Investigational Site, Custodistraße 3-17

    Cologne

  • Investigational Site, Wilhelm-Ewald-Weg 1

    Cologne

  • Investigational Site, Zeppelinstraße 1

    Cologne

  • Investigational Site

    Cottbus

  • Investigational Site, Karlstraße 30

    Crailsheim

  • Investigational Site, Postplatz 2

    Crailsheim

  • Investigational Site

    Delitzsch

  • Investigational Site

    Dessau

  • Investigational Site

    Dillenburg

  • Investigational Site

    Dinslaken

  • Investigational Site

    Dortmund

  • Investigational Site

    Dossenheim

  • Investigational Site

    Dresden

  • Investigational Site, Kreuzstraße 3-5

    Duisburg

  • Investigational Site, Königstraße 49

    Duisburg

  • Investigational Site

    Dülmen

  • Investigational Site

    Düsseldorf

  • Investigational Site

    Eisenhüttenstadt

  • Investigational Site, Geschwister-Scholl-Str. 6

    Erfurt

  • Investigational Site, Juri-Gagarin-Ring 94

    Erfurt

  • Investigational Site

    Essen

  • Investigational Site

    Finsterwalde

  • Investigational Site, Eschersheimer Landstr. 544

    Frankfurt

  • Investigational Site, Im Steinbügel 13

    Frankfurt

  • Investigational Site

    Freiburg im Breisgau

  • Investigational Site

    Freital

  • Investigational Site

    Friedberg

  • Investigational Site

    Friedrichshafen

  • Investigational Site, Arminstraße 24

    Gelsenkirchen

  • Investigational Site, Feldmarkstraße 109

    Gelsenkirchen

  • Investigational Site, Zum Ehrenmal 21

    Gelsenkirchen

  • Investigational Site

    Gera

  • Investigational Site

    Giessen

  • Investigational Site, Helenenstraße 10-12

    Gotha

  • Investigational Site, Schützenberg 10

    Gotha

  • Investigational Site

    Grimma

  • Investigational Site, Niemeyerstraße 23

    Halle

  • Investigational Site, Reilstraße 129 a

    Halle

  • Investigational Site, Steinweg 27

    Halle

  • Investigational Site, Alte Holstenstraße 16

    Hamburg

  • Investigational Site, Fuhlsbüttler Straße 182

    Hamburg

  • Investigational Site, Grindelberg 3

    Hamburg

  • Investigational Site, Herthastraße 12

    Hamburg

  • Investigational Site, Tangstedter Landstraße 77

    Hamburg

  • Investigational Site

    Hattersheim

  • Investigational Site

    Heidelberg

  • Investigational Site

    Heilbronn

  • Investigational Site

    Heinsberg

  • Investigational Site

    Hennigsdorf

  • Investigational Site

    Herford

  • Investigational Site, Enoch-Widmann-Straße 5

    Hof

  • Investigational Site, Eppenreuther Straße 28

    Hof

  • Investigational Site

    Isenburg

  • Investigational Site

    Jena

  • Investigational Site

    Jülich

  • Investigational Site

    Kaiserslautern

  • Investigational Site

    Kamenz

  • Investigational Site

    Kamp-Lintfort

  • Investigational Site

    Karlsruhe

  • Investigational Site

    Kempten

  • Investigational Site, Markt 11

    Kiel

  • Investigational Site, Prüner Gang 15

    Kiel

  • Investigational Site, Schulstraße 7

    Kiel

  • Investigational Site

    Kleinblittersdorf

  • Investigational Site, Friederikenstraße 30

    Köthen

  • Investigational Site, Siebenbrünnenpromenade 6-7

    Köthen

  • Investigational Site

    Krefeld

  • Investigational Site

    Kulmbach

  • Investigational Site

    Lampertheim

  • Investigational Site

    Langenau

  • Investigational Site

    Lebach

  • Investigational Site

    Leutkirch

  • Investigational Site

    Lichtenfels

  • Investigational Site

    Limbach-Oberfrohna

  • Investigational Site

    Lübeck

  • Investigational Site

    Lubnjow

  • Investigational Site

    Ludwigshafen

  • Investigational Site

    Lüneburg

  • Investigational Site

    Lünen

  • Investigational Site

    Magdeburg

  • Investigational Site

    Mainz

  • Investigational Site, N7, 9

    Mannheim

  • Investigational Site, Seckenheimer Hauptstraße 107

    Mannheim

  • Investigational Site

    Marburg

  • Investigational Site

    Marl

  • Investigational Site

    Mechernich

  • Investigational Site

    Merseburg

  • Investigational Site

    Merzig

  • Investigational Site

    Michelstadt

  • Investigational Site

    Miltenberg

  • Investigational Site

    Moers

  • Investigational Site

    Mölln

  • Investigational Site

    Mörlenbach

  • Investigational Site

    Mühlacker

  • Investigational Site

    Mühlhausen

  • Investigational Site

    Mühlheim

  • Investigational Site, Fürstenbergstraße 5

    Münster

  • Investigational Site, Hohenzollernring 70

    Münster

  • Investigational Site

    Naumburg

  • Investigational Site

    Neu-Ulm

  • Investigational Site

    Neunkirchen

  • Investigational Site

    Neuss

  • Investigational Site

    Nienburg

  • Investigational Site

    Norderstedt

  • Investigational Site, Bahnhofstraße 17

    Nordhausen

  • Investigational Site, Bahnhofstraße 8

    Nordhausen

  • Investigational Site, Am Museumsturm 4

    Nordhorn

  • Investigational Site, Osnabrücker Straße 1

    Nordhorn

  • Investigational Site, Am Stadtpark 2

    Nuremberg

  • Investigational Site, Hefnersplatz 1

    Nuremberg

  • Investigational Site, Kopernikusplatz 7

    Nuremberg

  • Investigational Site

    Obernburg

  • Investigational Site

    Ochsenfurt

  • Investigational Site

    Offenbach

  • Investigational Site

    Osnabrück

  • Investigational Site

    Paderborn

  • Investigational Site

    Pasewalk

  • Investigational Site

    Pirna-Copitz

  • Investigational Site

    Prüm

  • Investigational Site

    Pulheim

  • Investigational Site, Hindenburgstraße 10 A

    Rastatt

  • Investigational Site, Kaiserstraße 7

    Rastatt

  • Investigational Site, Gartenstraße 22

    Ravensburg

  • Investigational Site, Grüner-Turm-Straße 7-9

    Ravensburg

  • Investigational Site

    Regensburg

  • Investigational Site

    Remscheid

  • Investigational Site

    Ribnitz-Damgarten

  • Investigational Site, Große Wasserstraße 2 - 3

    Rostock

  • Investigational Site, Nobelstraße 51

    Rostock

  • Investigational Site, Trelleborger Straße 10B

    Rostock

  • Investigational Site

    Röthenbach an der Pegnitz

  • Investigational Site

    Rottweil

  • Investigational Site, Mainzer Straße 105

    Saarbrücken

  • Investigational Site, Viktoriastraße 2

    Saarbrücken

  • Investigational Site

    Saarlouis

  • Investigational Site

    Salzmünde

  • Investigational Site

    Schönebeck

  • Investigational Site

    Schwäbisch Gmünd

  • Investigational Site

    Schwandorf in Bayern

  • Investigational Site

    Schwerin

  • Investigational Site

    Schwerte

  • Investigational Site

    Senden

  • Investigational Site

    Sindelfingen

  • Investigational Site

    Sömmerda

  • Investigational Site, Kirchplatz 6a

    Spremberg

  • Investigational Site, Lustgartenstraße 3

    Spremberg

  • Investigational Site

    Stockelsdorf

  • Investigational Site

    Stolberg

  • Investigational Site

    Stuttgart

  • Investigational Site

    Sulzbach-Rosenberg

  • Investigational Site

    Tettnang

  • Investigational Site

    Tostedt

  • Investigational Site

    Trier

  • Investigational Site

    Troisdorf

  • Investigational Site

    Überlingen

  • Investigational Site, Hirschstraße 22

    Ulm

  • Investigational Site, Olgastraße 103

    Ulm

  • Investigational Site, Olgastraße 139

    Ulm

  • Investigational Site

    Velbert

  • Investigational Site

    Völklingen

  • Investigational Site

    VS-Villingen

  • Investigational Site

    Wangen

  • Investigational Site, Moosbürger Str. 13

    Weiden

  • Investigational Site, Postgasse 1

    Weiden

  • Investigational Site

    Weißenfels

  • Investigational Site

    Werl

  • Investigational Site

    Werningerode

  • Investigational Site

    Wesel

  • Investigational Site

    Wiesbaden

  • Investigational Site

    Wilhelmshaven

  • Investigational Site, Heinrich-Nordhoff-Straße 49

    Wolfsburg

  • Investigational Site, Porschestraße 100

    Wolfsburg

  • Investigational Site

    Würselen

  • Investigational Site

    Xanten

  • Investigational Site

    Zerbst

Other trials in Germany

About this study

Official title: 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.

Being tested
Firmagon given by prescription according to SPC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Firmagon given by prescription according to SPCOther

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

Study groups in NCT00930319
Study groupRoleWhat they receive
1Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
Receives: Other: Firmagon given by prescription according to SPC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. duration of the PSA progression-free survival

    Measured: open (until therapy end or stop)

Secondary outcomes (3)

  1. 1. testosterone levels

    Measured: open (until therapy end or stop)

  2. 2. number of ADRs and SUSARs

    Measured: open (until therapy end or stop)

  3. 3. quality of life

    Measured: open (until therapy end or stop)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930319
Sponsor's protocol ID
FE200486 CS41
Acronym
FAST
Status last verified
Mar 2014
First submitted
29 Jun 2009
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma, run by Ferring Pharmaceuticals at 230 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 230 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

duration of the PSA progression-free survival (time frame: open (until therapy end or stop)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00930319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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