Clinical trial · Observational
A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- FIRMAGON
- label
- GnRH Agonist
Primary outcomes (6)
- measure
- Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
- timeFrame
- From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
- description
- The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).
- measure
- Incidence Rate of AESI: Decreased Bone Density
- timeFrame
- From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
- description
- IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available