Prostate Cancer
Conditions
Brief summary
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.
Interventions
OTHERDegarelix Cohort
Non-interventional
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with prostate cancer and in need of ADT * Decision made to prescribe FIRMAGON® prior to enrollment * Willingness and ability to provide written informed consent * The participants are taking the marketed drug FIRMAGON®
Exclusion criteria
* Not signed informed consent * Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Adverse Events (AEs) | From the signing of the informed consent up to the end-of-trial (12 months) | 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. |
| Percentage of Participants With Serious AEs | From the signing of the informed consent up to the end-of-trial (12 months) | 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. |
Countries
China
Participant flow
Recruitment details
The study was performed at 145 investigational sites in China between August 2019 and December 2022.
Pre-assignment details
In total, 1454 participants were screened and all the participants enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| FIRMAGON Cohort FIRMAGON Cohort: Non-interventional | 1,454 |
| Total | 1,454 |
Baseline characteristics
| Characteristic | FIRMAGON Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1154 Participants |
| Age, Categorical Between 18 and 65 years | 300 Participants |
| Age, Continuous | 72.7 years STANDARD_DEVIATION 8.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1454 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 1454 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1454 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 55 / 1,454 |
| other Total, other adverse events | 95 / 1,454 |
| serious Total, serious adverse events | 63 / 1,454 |
Outcome results
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.
Time frame: From the signing of the informed consent up to the end-of-trial (12 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FIRMAGON Cohort | Percentage of Participants With Any Adverse Events (AEs) | 95 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.
Time frame: From the signing of the informed consent up to the end-of-trial (12 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FIRMAGON Cohort | Percentage of Participants With Serious AEs | 63 Participants |