N/A
Completed N=1,493
A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
Source: ClinicalTrials.gov NCT01234350 ↗Enrolled (actual)
1,493
Serious AEs
25.5%
Results posted
May 2019
Primary outcomePrimary: Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events — 3.8; 4.5 Events per 100 PYE — p=0.4007
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events |
3.8; 4.5 | 0.4007 |
| PRIMARY Incidence Rate of AESI: Decreased Bone Density |
1.1; 1.4; 0.3; 0.1 | 0.6710 |
| PRIMARY Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) |
15.3; 13.2; 1.8; 0.7 | 0.2529 |
| PRIMARY Change in Hepatic Enzymes |
-1.0; -1.0; -1.0; -2.0; -0.9; -0.6 | — |
| PRIMARY Change in Serum Glucose |
0.0; 0.0; 0.0; 0.0; 0.1; 0.1 | — |
| SECONDARY Number and Classification of New Adverse Drug Reactions (ADRs) |
0; 0 | — |
| SECONDARY Long Term Evaluation of Clinical Evolution of Prostate Cancer |
-20.1; -10.7; -19.1; -11.4; -17.0; -11.5 | — |
| SECONDARY Changes in Testosterone Levels |
-3.6; -3.0; -3.8; -3.3; -3.6; -3.190 | — |
| SECONDARY All-cause of Mortality |
6.5; 5.1 | 0.0821 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01234350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.