A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer (FAST-NL)

August 18, 2015 updated by: Ferring Pharmaceuticals

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

Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

274

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

  • Netherlands
      • Almere, Netherlands
        • Flevoziekenhuis
      • Amsterdam, Netherlands
        • BovenIJ Ziekenhuis
      • Assen, Netherlands
        • Wilhelminaziekenhuis
      • Beverwijk, Netherlands
        • Rode Kruis Ziekenhuis
      • Blaricum, Netherlands
        • Tergooiziekenhuizen
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Capelle aan den IJssel, Netherlands
        • Ljsselland Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Groep
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis, locatie Carolus
      • Den Haag, Netherlands
        • Hagaziekenhuis loc. Leyweg
      • Den Haag, Netherlands
        • Hagaziekenhuis loc. Sportlaan
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Doetinchem, Netherlands
        • Slingeland ziekenhuis
      • Dordrecht, Netherlands
        • Alb.Schweitzer Ziekenhuis, loc. Dordwijk
      • Ede, Netherlands
        • Gelderse Vallei, loc. Barneveld
      • Geldrop, Netherlands
        • St. Anna Ziekenhuis
      • Goes, Netherlands
        • Admiraal de Ruyter Ziekenhuis
      • Gorinchem, Netherlands
        • Rivas Beatrixziekenhuis
      • Gouda, Netherlands
        • Het Groene Hart Ziekenhuis
      • Groenlo, Netherlands
        • Buitenpolikliniek
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Harderwijk, Netherlands
        • Ziekenhuis St Jansdal
      • Helmond, Netherlands
        • Elkerliek Ziekenhuis
      • Hilversum, Netherlands
        • Tergooiziekenhuizen
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Leiden, Netherlands
        • LUMC
      • Leiderdorp, Netherlands
        • Rijnland Ziekenhuis
      • Maastricht, Netherlands
        • MUMC
      • Oss, Netherlands
        • Ziekenhuis Bernhoven, loc. Oss
      • Purmerend, Netherlands
        • Waterland Ziekenhuis
      • Roosendaal, Netherlands
        • Franciscus Ziekenhuis
      • Rotterdam, Netherlands
        • Havenziekenhuis
      • Rotterdam, Netherlands
        • Vlietland ziekenhuis
      • Sittard-Geleen, Netherlands
        • Orbis Medisch Centrum
      • Sliedrecht, Netherlands
        • Alb. Schweitzer Ziekenhuis loc. Sliedrecht
      • Sneek, Netherlands
        • Antonius Ziekenhuis
      • Spijkenisse, Netherlands
        • Ruwaard v Putten/vWeel Bethesda Zkhs
      • Terneuzen, Netherlands
        • Zorgzaam Ziekenhuis
      • Tiel, Netherlands
        • Ziekenhuis Rivierenland
      • Utrecht, Netherlands
        • Diakonessenhuis Utrecht
      • Utrecht, Netherlands
        • Antonius Ziekenhuis, loc. Oudenrijn
      • Veghel, Netherlands
        • Ziekenhuis Bernhoven, loc. Veghel
      • Veldhoven, Netherlands
        • Maxima Medisch Centrum
      • Vlissingen, Netherlands
        • Admiraal de Ruyter Ziekenhuis
      • Weert, Netherlands
        • St. Jans Gasthuis
      • Zwijndrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced prostate cancer

Description

Inclusion Criteria:

- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy

Exclusion Criteria:

- Patients with a contraindication for prescription of Firmagon®

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate the progression-free survival (PFS) failure rate
Time Frame: Maximum 3 years
Maximum 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects
Time Frame: Every 3 months (during 3 years)
Every 3 months (during 3 years)
To prescribe the change in patient's quality of life (QoL) during therapy.
Time Frame: From study start and after 6 months
From study start and after 6 months
To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy
Time Frame: From study start, after 3 months and at end of treatment
From study start, after 3 months and at end of treatment
To assess the reduction of prostate volume (neoadjuvant therapy)
Time Frame: Fom baseline after 3 months
Fom baseline after 3 months

Collaborators and Investigators

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

Sponsor

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

October 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS46

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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