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OpenTrials
Completed

NCT Number: NCT00930319

Effectiveness and Safety of Firmagon®

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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Key information

Conditions

Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Investigational Site, Heinrich-Rieger-Str. 15, Aalen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • therapeutic need according to SPC
  • written informed consent

Exclusion criteria

  • contraindications according to SPC

Treatment and study plan

Firmagon given by prescription according to SPC

Other

Non-interventional,observational Firmagon given by prescription according to SPC

Primary outcomes

  1. duration of the PSA progression-free survival

    Time frame: open (until therapy end or stop)

Secondary outcomes

  1. 1. testosterone levels

    Time frame: open (until therapy end or stop)

  2. 2. number of ADRs and SUSARs

    Time frame: open (until therapy end or stop)

  3. 3. quality of life

    Time frame: open (until therapy end or stop)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring Arzneimittel GmbH

Registry information

Official study title

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

Acronym: FAST

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2009
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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