Status:

COMPLETED

A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

Lead Sponsor:

Ferring Pharmaceuticals

Conditions:

Prostate Cancer

Eligibility:

MALE

Brief Summary

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone ...

Eligibility Criteria

Inclusion

  • 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

  • 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 subjects 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.

Key Trial Info

Start Date :

January 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 27 2018

Estimated Enrollment :

1493 Patients enrolled

Trial Details

Trial ID

NCT01234350

Start Date

January 1 2011

End Date

March 27 2018

Last Update

June 25 2019

Active Locations (160)

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Page 1 of 40 (160 locations)

1

Onze-Lieve-Vrouwziekenhuis

Aalst, Belgium

2

Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

Antwerp, Belgium

3

AZ Sint-Jan AV

Bruges, Belgium

4

Hôpitaux IRIS Sud

Brussels, Belgium