Prostate Cancer
Conditions
Brief summary
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.
Interventions
None listed
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
\- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy
Exclusion criteria
\- Patients with a contraindication for prescription of Firmagon®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the progression-free survival (PFS) failure rate | Maximum 3 years |
Secondary
| Measure | Time frame |
|---|---|
| To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects | Every 3 months (during 3 years) |
| To prescribe the change in patient's quality of life (QoL) during therapy. | From study start and after 6 months |
| To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy | From study start, after 3 months and at end of treatment |
| To assess the reduction of prostate volume (neoadjuvant therapy) | Fom baseline after 3 months |
Countries
Netherlands
Outcome results
None listed