Prostate Cancer
Conditions
Keywords
Safety parameters, ECG, blood and urine samples, general health state
Brief summary
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
Interventions
DRUGDegarelix
Sponsors
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
* Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
Exclusion criteria
* Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | Up to 22.5 months | 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 | Up to 22.5 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Levels of Prostate Specific Antigen (PSA)Over Time | from baseline to 72 weeks | PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9) |
| Serum Levels of Testosterone Over Time | from baseline to week 72 | Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9) |
Countries
Belgium, France, Italy, Portugal, Spain, Sweden, Turkey (Türkiye)
Participant flow
Recruitment details
The patients were recruited from 16 sites in Belgium, France, Italy, Spain, Sweden and Turkey. The study was conducted between 31 August 2009 (FPFV) and 29 November 2011 (LPLV).
Participants by arm
| Arm | Count |
|---|---|
| Degarelix The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. | 77 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Miscellaneous Reasons | 9 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Degarelix |
|---|---|
| Age Continuous | 71.9 years STANDARD_DEVIATION 7.59 |
| Body Mass Index (BMI) | 27.2 kilogram per square meter STANDARD_DEVIATION 4.2 |
| Gleason Score Gleason Score 2-4 | 1 Participants |
| Gleason Score Gleason Score 5-6 | 18 Participants |
| Gleason Score Gleason Score 7-10 | 58 Participants |
| Region of Enrollment Belgium | 2 participants |
| Region of Enrollment France | 2 participants |
| Region of Enrollment Italy | 35 participants |
| Region of Enrollment Spain | 11 participants |
| Region of Enrollment Sweden | 13 participants |
| Region of Enrollment Turkey | 14 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 77 Participants |
| Stage of Prostate Cancer Localized | 36 Participants |
| Stage of Prostate Cancer Locally Advanced | 19 Participants |
| Stage of Prostate Cancer Metastatic | 15 Participants |
| Stage of Prostate Cancer Not Classifiable | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 77 |
| serious Total, serious adverse events | 5 / 77 |
Outcome results
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 percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time frame: Up to 22.5 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 24 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 6 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) <=2.8 | 2 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 |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 3 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Platelet count (10^9/L) <=75 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Aspartate aminotransferase (IU/L) >3xULN | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 5 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 table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time frame: Up to 22.5 months
| 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 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 Participants |
| Degarelix | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 2 Participants |
Other Pre-specified
Serum Levels of Prostate Specific Antigen (PSA)Over Time
PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
Time frame: from baseline to 72 weeks
Population: The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA)Over Time | Baseline (0 weeks) | 1.4 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA)Over Time | Week 24 | 0.75 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA)Over Time | Week 36 | 0.6 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA)Over Time | Week 48 | 0.55 ng/mL |
| Degarelix | Serum Levels of Prostate Specific Antigen (PSA)Over Time | Week 72 | 1.9 ng/mL |
Other Pre-specified
Serum Levels of Testosterone Over Time
Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
Time frame: from baseline to week 72
Population: The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix | Serum Levels of Testosterone Over Time | Week 72 | 0.12 ng/mL |
| Degarelix | Serum Levels of Testosterone Over Time | Baseline (Week 0) | 0.05 ng/mL |
| Degarelix | Serum Levels of Testosterone Over Time | Week 24 | 0.05 ng/mL |
| Degarelix | Serum Levels of Testosterone Over Time | Week 36 | 0.05 ng/mL |
| Degarelix | Serum Levels of Testosterone Over Time | Week 48 | 0.08 ng/mL |