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To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON®).
Study Design
This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIRMAGON® Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix Cohort | Other | Non-interventional |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment. | From the signing of the informed consent up to the end-of-trial (12 months) |
| Percentage of Participants With Serious AEs | An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction. | From the signing of the informed consent up to the end-of-trial (12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with diagnosis of prostate cancer needing ADT.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Primary Healthcare Foundation | Beijing | China |
In total, 1454 participants were screened and all the participants enrolled in the study
The study was performed at 145 investigational sites in China between August 2019 and December 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | FIRMAGON Cohort | FIRMAGON Cohort: Non-interventional |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FIRMAGON Cohort | FIRMAGON Cohort: Non-interventional |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Any Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment. | Posted | Count of Participants | Participants | From the signing of the informed consent up to the end-of-trial (12 months) |
|
|
From the signing of the informed consent up to the end-of-trial (12 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FIRMAGON Cohort | FIRMAGON Cohort: Non-interventional | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | +1 833-548-1402 | DK0-Disclosure@ferring.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2020 | Sep 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Percentage of Participants With Serious AEs | An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction. | Posted | Count of Participants | Participants | From the signing of the informed consent up to the end-of-trial (12 months) |
|
|
|
| 1,454 |
| 63 |
| 1,454 |
| 95 |
| 1,454 |
| Injection site reactions | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Coronavirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Death (unknown cause) | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Injection site reactions | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Urine abnormality | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Urinary tract inflammation | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Poor quality sleep | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Coronavirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |