Post Authorisation Safety Study (PASS) on Patients With Advanced Prostate Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study is a large observational study set-up to observe how the long-term treatment of Firmagon (hormone regulator) compared to another treatment will effect specific conditions such as cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in patients with prostate cancer. Patients will be treated according to their routine clinical care and this will not be dictated by the study. As the study is observational in nature, the study will collect specific data relating to the 3 specific events above. Patients that agree to this study will be followed-up for 5 years. Patient data will be collected every 3 months for the first 2 years and every 6 months for the last 3 yrs.
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, Learn About Clinical Studies.
Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with prostate cancer from primary care
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
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.