Prostate Cancer
Conditions
Brief summary
The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.
Interventions
DRUGDegarelix
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent before any study-related activity is performed * Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment * Age greater than or equal to 18 years and less than 80 years * Advanced hormone-dependent prostate cancer without any other clinically significant disorder * Easten Cooperative Oncology Group score ≤ 2 * PSA ≥ 2 ng/mL at screening * Life expectancy of at least 12 months as per the investigator's judgement
Exclusion criteria
* Previous or concurrent hormonal management of prostate cancer * Contraindication for prescription of Firmagon® * Concurrent treatment with a 5-α-reductase inhibitor * Considered as a candidate for curative therapy * History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema * QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications * Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin * Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment) * Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer * Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant changes in vital signs | From baseline to Day 364 |
| Frequency of adverse events | Up to Day 364 |
| Severity of adverse events | Up to Day 364 |
| Clinically significant changes in laboratory values (hematology and clinical biochemistry) | From baseline to Day 364 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative probability of no Prostate Specific Antigen (PSA) failure | Up to Day 364 | PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart |
| Cumulative probability of Progression Free Survival (PFS) | Up to Day 364 | PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first |
| Change in International Prostate Symptom Score (IPSS) | From baseline to Day 364 | — |
| Change in physician's satisfaction score | From baseline to Day 364 | — |
Countries
India
Outcome results
None listed