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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Clinically significant changes in vital signs | From baseline to Day 364 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative probability of no Prostate Specific Antigen (PSA) failure | 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 | Up to Day 364 |
| Cumulative probability of Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. P Medical College and AG of Hospitals | Bikaner | Rajasthan | India | |||
| Krishna Institute of Medical Sciences |
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PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first |
| Up to Day 364 |
| Change in International Prostate Symptom Score (IPSS) | From baseline to Day 364 |
| Change in physician's satisfaction score | From baseline to Day 364 |
| Secunderabad |
| Telangana |
| India |
| Bodyline Hospitals | Ahmedabad | India |
| HCG Multi Specialty Hospital | Ahmedabad | India |
| Shalby Hospital | Ahmedabad | India |
| HealthCare Global Enterprises Limited | Bangalore | India |
| KLE's Dr. Prabhakar Kore Hospital & MRC | Belagavi | India |
| Apollo Speciality Hospital | Chennai | India |
| Rajiv Gandhi Cancer Institute and Research Centre | Delhi | India |
| Muljibhai Patel Urological Hospital | Gujrāt | India |
| CHL Hospital | Indore | India |
| SMS Medical College & Attached Hospital's | Jaipur | India |
| Tata Medical Center | Kolkata | India |
| King's George Medical University | Lucknow | India |
| Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute | Mumbai | India |
| Tata Memorial Hospital | Mumbai | India |
| Government Medical College and Super Specialty Hospital | Nagpur | India |
| Rml & Pgimer | New Delhi | India |
| Aman Hospital and Research Center | Vadodara | India |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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