Effectiveness and Safety of Firmagon® (FAST)

This study has been completed.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00930319
First received: June 29, 2009
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • duration of the PSA progression-free survival [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. testosterone levels [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: No ]
  • 2. number of ADRs and SUSARs [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: Yes ]
  • 3. quality of life [ Time Frame: open (until therapy end or stop) ] [ Designated as safety issue: No ]

Enrollment: 676
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

  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: NCT00930319

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00930319     History of Changes
Other Study ID Numbers: FE200486 CS41
Study First Received: June 29, 2009
Last Updated: March 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 11, 2014