Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Firmagon (Degarelix)
: At Day 0, patients will receive the starting dose of Degarelix 240 mg
(administered as two SC injections of 120 mg [40 mg/mL]) followed by monthly (28-day interva
starting from
Day 28 ± 2 / Month 1 to Day 336 ± 7 / Month 12.
Control Intervention1: Not Applicable.: Not Applicable.
Sponsors
Ferring Pharmaceutical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Each patient must meet the following inclusion criteria before entry into the trial: 1) Has given written informed consent before any study-related activity is performed 2) Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated 3) Age greater than or equal to 18 years and less than 80 years 4) Advanced hormone-dependent prostate cancer without any other clinically significant disorder 5) PSA >= 2 ng/mL at screening
Exclusion criteria
Exclusion criteria: Any patient meeting one or more of the following exclusion criteria will not enter into the trial: 1. Previous or concurrent hormonal management of prostate cancer 2. Contraindication for prescription of Firmagon® 3. Concurrent treatment with a 5-α-reductase inhibitor 4. Considered as a candidate for curative therapy 5. History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema 6. QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications 7. Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin 8. Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment) 9. Patients clinically significant laboratory abnormalities / disorders other than prostate cancer 10. Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Firmagon® safety profile will be evaluated during the treatment period by the following parameters: â?¢ Frequency of adverse events [Time Frame: Up to Day 364] â?¢ Severity of adverse events [Time Frame: Up to Day 364] â?¢ Clinically significant changes in laboratory values (hematology and clinical biochemistry) [Time Frame: From baseline to Day 364] â?¢ Clinically significant changes in vital signs [Time Frame: From baseline to Day 364]Timepoint: Up to Day 364/From baseline to Day 364 | — |
Secondary
| Measure | Time frame |
|---|---|
| The Firmagon® efficacy profile will be evaluated during the treatment period by the following parameters: â?¢ Cumulative probability of no Prostate Specific Antigen (PSA) failure [Time Frame: Up to Day 364] â?¢ Cumulative probability of Progression Free Survival (PFS) [Time Frame: Up to Day 364] â?¢ Change in International Prostate Symptom Score (IPSS) [Time Frame: From baseline to Day 364] â?¢ Change in physicians satisfaction score [Time Frame: From baseline to Day 364] Timepoint: Up to Day 364/From baseline to Day 364 | — |
Countries
India
Contacts
Public ContactBindu Nair
Ferring Pharmaceutical Pvt. Ltd
Outcome results
None listed