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

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01215526
Collaborator
(none)
274
Enrollment
47
Locations
57
Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    274 participants
    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
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. To estimate the progression-free survival (PFS) failure rate [Maximum 3 years]

    Secondary Outcome Measures

    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 [Every 3 months (during 3 years)]

    2. To prescribe the change in patient's quality of life (QoL) during therapy. [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 [From study start, after 3 months and at end of treatment]

    4. To assess the reduction of prostate volume (neoadjuvant therapy) [Fom baseline after 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Flevoziekenhuis Almere Netherlands
    2 Bovenij Ziekenhuis Amsterdam Netherlands
    3 Wilhelminaziekenhuis Assen Netherlands
    4 Rode Kruis Ziekenhuis Beverwijk Netherlands
    5 Tergooiziekenhuizen Blaricum Netherlands
    6 Amphia Ziekenhuis Breda Netherlands
    7 Ljsselland Ziekenhuis Capelle aan den IJssel Netherlands
    8 Reinier de Graaf Groep Delft Netherlands
    9 Jeroen Bosch Ziekenhuis, locatie Carolus Den Bosch Netherlands
    10 Hagaziekenhuis loc. Leyweg Den Haag Netherlands
    11 Hagaziekenhuis loc. Sportlaan Den Haag Netherlands
    12 Deventer Ziekenhuis Deventer Netherlands
    13 Slingeland Ziekenhuis Doetinchem Netherlands
    14 Alb.Schweitzer Ziekenhuis, loc. Dordwijk Dordrecht Netherlands
    15 Gelderse Vallei, loc. Barneveld Ede Netherlands
    16 St. Anna Ziekenhuis Geldrop Netherlands
    17 Admiraal de Ruyter Ziekenhuis Goes Netherlands
    18 Rivas Beatrixziekenhuis Gorinchem Netherlands
    19 Het Groene Hart Ziekenhuis Gouda Netherlands
    20 Buitenpolikliniek Groenlo Netherlands
    21 Martini Ziekenhuis Groningen Netherlands
    22 Ziekenhuis St Jansdal Harderwijk Netherlands
    23 Elkerliek Ziekenhuis Helmond Netherlands
    24 Tergooiziekenhuizen Hilversum Netherlands
    25 Medisch Centrum Leeuwarden Leeuwarden Netherlands
    26 LUMC Leiden Netherlands
    27 Rijnland Ziekenhuis Leiderdorp Netherlands
    28 MUMC Maastricht Netherlands
    29 Ziekenhuis Bernhoven, loc. Oss Oss Netherlands
    30 Waterland Ziekenhuis Purmerend Netherlands
    31 Franciscus Ziekenhuis Roosendaal Netherlands
    32 Havenziekenhuis Rotterdam Netherlands
    33 Vlietland Ziekenhuis Rotterdam Netherlands
    34 Orbis Medisch Centrum Sittard-Geleen Netherlands
    35 Alb. Schweitzer Ziekenhuis loc. Sliedrecht Sliedrecht Netherlands
    36 Antonius Ziekenhuis Sneek Netherlands
    37 Ruwaard v Putten/vWeel Bethesda Zkhs Spijkenisse Netherlands
    38 Zorgzaam Ziekenhuis Terneuzen Netherlands
    39 Ziekenhuis Rivierenland Tiel Netherlands
    40 Antonius Ziekenhuis, loc. Oudenrijn Utrecht Netherlands
    41 Diakonessenhuis Utrecht Utrecht Netherlands
    42 Ziekenhuis Bernhoven, loc. Veghel Veghel Netherlands
    43 Maxima Medisch Centrum Veldhoven Netherlands
    44 Admiraal de Ruyter Ziekenhuis Vlissingen Netherlands
    45 St. Jans Gasthuis Weert Netherlands
    46 Albert Schweitzer Ziekenhuis Zwijndrecht Netherlands
    47 Isala Klinieken Zwolle Netherlands

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Clinical Development Support, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01215526
    Other Study ID Numbers:
    • FE200486 CS46
    First Posted:
    Oct 6, 2010
    Last Update Posted:
    Aug 19, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 19, 2015