Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004051

Trial Description

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Title

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

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Trial Acronym

FAST

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00004051
  •   2012/07/24
  •   2009/06/29
  •   no
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Secondary IDs

  •   NCT00930319  (ClinicalTrials.gov)
  •   FE200486 CS41  (Ferring Pharmaceuticals)
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Health Condition or Problem studied

  •   Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Other: Firmagon given by prescription according to SPC
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- duration of the PSA progression-free survival; time frame: open (until therapy end or stop)

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Secondary Outcome

- 1. testosterone levels; time frame: open (until therapy end or stop)
- 2. number of ADRs and SUSARs; time frame: open (until therapy end or stop)
- 3. quality of life; time frame: open (until therapy end or stop)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2009/06/30
  •   671
  •   Multicenter trial
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- therapeutic need according to SPC

- written informed consent

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Exclusion Criteria

- contraindications according to SPC

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Addresses

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    • Ferring Pharmaceuticals
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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  • start of 1:1-Block address public-contact
    • Ferring Pharmaceuticals
    • Clinical Development Support 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.