Prostate Cancer
Conditions
Brief summary
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
Interventions
DRUGDegarelix 240/80 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
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. * Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy) * Is a male patient aged 18 years or older * Has a screening serum testosterone level \>1.5 ng/mL * Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2 * Has a screening PSA value of ≥2 ng/mL * Has a life expectancy of at least 12 months
Exclusion criteria
* Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit * Is currently treated with a 5-α-reductase inhibitor * Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy * Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema * Has hypersensitivity towards any component of the investigational medicinal product * A marked baseline prolongation of QT/QTcF interval * A history of additional risk factors for Torsade de Pointes ventricular arrhythmias * Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin * Has a known or suspect hepatic, symptomatic biliary disease * Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days * Has other clinically significant laboratory abnormalities * Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse * Has a mental incapacity or language barriers precluding adequate understanding or co- operation * Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial * Has previously participated in any degarelix trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 | Day 28 to Day 196 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 | At day 3 | — |
| Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 | To Day 28 | — |
| Cumulative Probability of no PSA Failure From Day 28 to Day 196 | To Day 196 | PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | To Day 196 | 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 percentage of participants in either group with abnormal value are presented, more variables were included in the study. |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | To Day 196 | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value. |
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 | Day 56 to Day 196 | — |
Countries
South Korea
Participant flow
Recruitment details
The patients were recruited from 11 sites in Korea. The study was conducted between 08 March 2010 (FPFV) and 07 November 2011 (LPLV).
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 240/80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168. | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Miscellaneous Reasons | 2 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Degarelix 240/80 mg |
|---|---|
| Age Continuous | 72.6 years STANDARD_DEVIATION 8.08 |
| Body Mass Index (BMI) | 23.8 kilogram per square meter STANDARD_DEVIATION 2.98 |
| Gleason Score Gleason Score 2-4 | 0 Participants |
| Gleason Score Gleason Score 5-6 | 24 Participants |
| Gleason Score Gleason Score 7-10 | 130 Participants |
| Region of Enrollment Korea, Republic of | 155 participants |
| Serum Protsate-Specific Antigen (PSA) Levels | 19.2 ng/mL |
| Serum Testosterone Level | 4.03 nanograms per milliliter (ng/mL) |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 155 Participants |
| Stage of Prostate Cancer Localized | 43 Participants |
| Stage of Prostate Cancer Locally Advanced | 60 Participants |
| Stage of Prostate Cancer Metastatic | 39 Participants |
| Stage of Prostate Cancer Not Classifiable | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 113 / 156 |
| serious Total, serious adverse events | 18 / 156 |
Outcome results
Primary
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
Time frame: Day 28 to Day 196
Population: 152 participants for this outcome measure is the analysis population from day 28 to day 196
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix 240/80 mg | Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 | 96.7 percent probability |
Secondary
Cumulative Probability of no PSA Failure From Day 28 to Day 196
PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Time frame: To Day 196
Population: 152 participants for this outcome measure is the analysis population from day 28 to day 196
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix 240/80 mg | Cumulative Probability of no PSA Failure From Day 28 to Day 196 | 97.3 percent probability |
Secondary
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Time frame: Day 56 to Day 196
Population: 152 participants for this outcome measure is the analysis population from day 56 to day 196
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix 240/80 mg | Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 | 96.7 percent probability |
Secondary
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 percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time frame: To Day 196
Population: Safety analysis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 73 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 5 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) <=2.8 | 1 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) >=16.0 | 1 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 19 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 1 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 10 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Sodium (mmol/L) <=130 | 2 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 8 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Lymphocytes (%) <=10 | 4 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Eosinophils (%) >=10 | 7 participants |
Secondary
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 table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time frame: To Day 196
Population: Safety analyis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 6 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 12 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 4 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 4 participants |
| Degarelix 240/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 12 participants |
Secondary
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Time frame: To Day 28
Population: 152 participants for this outcome measure is the analysis population from day 0 to day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 240/80 mg | Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 | -79.7 percent |
Secondary
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Time frame: At day 3
Population: Observed cases
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 240/80 mg | Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 | 97.4 percent |