Clinical trial · Observational
Effectiveness and Safety of Firmagon®
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
- 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)
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.
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 |
|---|---|---|---|
| Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Firmagon given by prescription according to SPC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC
- interventionNames
- Other: Firmagon given by prescription according to SPC
Primary outcomes (1)
- measure
- duration of the PSA progression-free survival
- timeFrame
- open (until therapy end or stop)
Secondary outcomes (3)
- measure
- 1. testosterone levels
- timeFrame
- open (until therapy end or stop)
- measure
- 2. number of ADRs and SUSARs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * therapeutic need according to SPC * written informed consent Exclusion Criteria: \- contraindications according to SPC
References
Publications (0)
Data not yet available