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Effectiveness and Safety of Firmagon® (FAST)

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ClinicalTrials.gov Identifier: NCT00930319
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment
Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma Other: Firmagon given by prescription according to SPC

Study Type : Observational
Actual Enrollment : 676 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
Study Start Date : June 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Group/Cohort Intervention/treatment
1
Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
Other: Firmagon given by prescription according to SPC
Non-interventional,observational Firmagon given by prescription according to SPC




Primary Outcome Measures :
  1. duration of the PSA progression-free survival [ Time Frame: open (until therapy end or stop) ]

Secondary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Advanced Hormone-dependent Prostate Carcinoma
Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

- contraindications according to SPC


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930319


  Show 231 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00930319     History of Changes
Other Study ID Numbers: FE200486 CS41
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases