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

Ferring

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01234350

FE200486 CS39

Details and patient eligibility

About

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 density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

Enrollment: 1,493 patients

Sex: Male

Volunteers: No Healthy Volunteers

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 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.

Trial design

1,493 participants in 2 patient groups

FIRMAGON

GnRH Agonist