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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01215526
First received: October 5, 2010
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • To estimate the progression-free survival (PFS) failure rate [ Time Frame: Maximum 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • To prescribe the change in patient's quality of life (QoL) during therapy. [ Time Frame: From study start and after 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the reduction of prostate volume (neoadjuvant therapy) [ Time Frame: Fom baseline after 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with advanced prostate cancer

Criteria

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®

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215526

Locations
Netherlands
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
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01215526     History of Changes
Other Study ID Numbers: FE200486 CS46
Study First Received: October 5, 2010
Last Updated: April 22, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014