FIRMAGON Intensive Drug Monitoring Protocol

Study Overview
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Brief Summary
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To evaluate the safety profile of FIRMAGON (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese patients 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 patients with prostate cancer and need ADT receiving treatment with FIRMAGON. This program will provide the minimum 6 doses and maximum 12 doses of FIRMAGON to enrolled patients during one-year follow-up. Patients who meet inclusion criteria and will or are accepting at least 6 self-financed doses treatment in hospital. Patients should return to the hospital for medical assessment every three months. The prescription of 6 (3 dose × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-patient pharmacy will distribute FIRMAGON to eligible patients (patients should bring the prescriptions and the last FIRMAGON boxes to get other doses). All enrolled patients will be 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 comes first.

Official Title
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A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer and Need Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: FIRMAGON Cohort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis as prostate cancer and need ADT Decision made to prescribe FIRMAGON prior to enrollment Willingness and ability to provide written informed consent The patients are taking the marketed drug FIRMAGON Exclusion Criteria: Not signed informed consent Any patients who is unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FIRMAGON Cohort<br> | Other: FIRMAGON Cohort<br>* Non-interventional<br>* Other names: Degarelix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with any adverse events (AEs) | An AE was defined as any untoward medical occurrence in a patient 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 subjects 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) |