CClinicalTrials.gg
CompletedNCT01215526FAST-NLUpdated Aug 19, 2015

A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer

An observational study in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Completed at 47 sites in Netherlands. Open to male participants. Per ClinicalTrials.gov, last updated 2015-08-19.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
274
Sex
Male
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Study summary

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.

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Conditions studied

  • Prostate Cancer

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 274 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced prostate cancer

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with a contraindication for prescription of Firmagon®
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
274 participants (actual)
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What researchers measure

Primary outcomes

  1. To estimate the progression-free survival (PFS) failure rate

    Time frame: Maximum 3 years

Secondary outcomes

  1. 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)

  2. To prescribe the change in patient's quality of life (QoL) during therapy.

    Time frame: From study start and after 6 months

  3. 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

  4. To assess the reduction of prostate volume (neoadjuvant therapy)

    Time frame: Fom baseline after 3 months

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01215526
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 6, 2010
Start date
Oct 2010
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 19, 2015

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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