A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With Firmagon (Degarelix) on a GnRH Agonist
N/A
N/A
N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With Firmagon (Degarelix) on a GnRH Agonist
Inclusion Criteria:
- Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)
- Decision made to prescribe ADT prior to enrolment
- Willing and able to provide written informed consent
Exclusion Criteria:
- Participation in an interventional clinical study in which any treatment or follow-up
is mandated
- Treatment with a GnRH receptor antagonist other than Firmagon
- Had previous or is currently under hormonal management of prostate cancer, except for
patients who have undergone therapy with curative intention where
neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be
terminated at least 6 months prior to baseline.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Incidence of adverse events of special interest (AESI)
Outcome Description:
Risk of cardiovascular events, decreased bone density, onset or exacerbation of glucose intolerance and changes in liver enzyme level
Outcome Time Frame:
Every 3 months from the first 2 years of the trial
Safety Issue:
Yes
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study ID:
FE200486 CS39
NCT ID:
NCT01234350
Start Date:
January 2011
Completion Date:
December 2017
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|
