Prostate Cancer
Conditions
Brief summary
This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.
Interventions
DRUGDegarelix
Sponsors
Ferring Pharmaceuticals Korea, Ltd.
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient * Has completed the 7-month main trial, FE200486 CS42
Exclusion criteria
* Has been withdrawn/discontinued from the FE200486 CS42 trial * A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | From baseline (day 0) to end of treatment (up to day 364) | The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | From baseline (day 0) to end of treatment (up to day 364) | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value. |
| Number of Participants With Markedly Abnormal Values in ECG Variables | From baseline (day 0) to end of treatment (up to day 364) | This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Levels of Prostate Specific Antigen (PSA) Over Time | Day 0, day 196, day 280, and day 364 | PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109). |
Countries
South Korea
Participant flow
Recruitment details
The participants were recruited from 9 sites in Korea. All participants had completed the 7-month main study (CS42, NCT01071915) prior to enrollment into this extension study (CS42A). The CS42A study was conducted between 20 September 2010 (FPFV) and 25 April 2012 (LPLV).
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals | 156 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse event (CS42A) | 2 |
| Overall Study | Miscellaneous reasons (CS42A) | 2 |
| Overall Study | Not completed CS42 | 9 |
| Overall Study | Not enrolled from CS42 to CS42A | 21 |
| Overall Study | Physician decision (CS42A) | 6 |
| Overall Study | Withdrawal by subject (CS42A) | 5 |
Baseline characteristics
| Characteristic | Degarelix |
|---|---|
| Age Continuous | 72.6 years STANDARD_DEVIATION 8.06 |
| Region of Enrollment Korea, Republic of | 156 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 88 / 156 |
| serious Total, serious adverse events | 25 / 156 |
Outcome results
Primary
Number of Participants With Markedly Abnormal Values in ECG Variables
This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time frame: From baseline (day 0) to end of treatment (up to day 364)
Population: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | PR interval (msec) <=120 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | PR interval (msec) >=220 | 3 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QRS interval (msec) >=120 | 3 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QT interval (msec) >=450 | 27 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QT interval (msec) >=480 | 6 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QT interval (msec) >=500 | 2 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QT interval increase of >=30 from baseline | 69 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QT interval increase of >=60 from baseline | 20 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QTcF (msec) >=450 | 25 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QTcF (msec) >=480 | 3 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QTcF (msec) >=500 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QTcF increase of >=30 from baseline | 39 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | QTcF increase of >=60 from baseline | 8 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | Ventricular rate (beats/min) <=50 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in ECG Variables | Ventricular rate (beats/min) >=120 | 2 Participants |
Primary
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
Time frame: From baseline (day 0) to end of treatment (up to day 364)
Population: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Cholesterol (mmol/L) >=8.0 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 10 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Sodium (mmol/L) <=130 | 2 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Total bilirubin (micromol/L) >1.5xULN | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 10 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Basophils (%) >=5 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Eosinophils (%) >=10 | 7 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (ratio) <=0.37 | 83 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 9 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Lymphocytes (%) <=10 | 4 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Neutrophils (%) >=90 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 25 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) <=2.8 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) >=16.0 | 1 Participants |
Primary
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time frame: From baseline (day 0) to end of treatment (up to day 364)
Population: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 13 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 20 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Pulse rate <=50 and decrease >=15 | 10 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Pulse rate >=120 and increase >=15 | 0 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7% from baseline | 4 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7% from baseline | 12 Participants |
Secondary
Serum Levels of Prostate Specific Antigen (PSA) Over Time
PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).
Time frame: Day 0, day 196, day 280, and day 364
Population: CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA) Over Time | Baseline (Day 0) | 19.2 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA) Over Time | Day 196 | 0.67 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA) Over Time | Day 280 | 0.52 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA) Over Time | Day 364 | 0.46 ng/mL |