Prostate Cancer
Conditions
Keywords
Degarelix, prostate cancer
Brief summary
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Interventions
DRUGDegarelix 80 mg / Degarelix 80 mg
DRUGDegarelix 160 mg / Degarelix 160 mg
DRUGLeuprolide 7.5 mg / Degarelix 80 mg
DRUGLeuprolide 7.5 mg / Degarelix 160 mg
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion/
Exclusion criteria
* Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * Signed informed consent * The patients must have completed the FE 200486 CS21 Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Up to 4 years of treatment | 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 (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | Up to 4 years of treatment | This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | From time of switch to Day 56 | — |
| Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | From time of switch to Day 56 | — |
| Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Until all participants have received at least 5 years of treatment and at a frequency of every 3 months | PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI). |
| Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | From time of switch to Day 56 | — |
| Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | From time of switch to Day 56 | — |
| Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Until all participants have received at least 5 years of treatment and at a frequency of every 6 months | The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study. |
Countries
Canada, Czechia, Germany, Hungary, Mexico, Netherlands, Puerto Rico, Romania, Russia, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results.
Pre-assignment details
Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 80 mg / Degarelix 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 doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. | 125 |
| Degarelix 160 mg / Degarelix 160 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 monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. | 126 |
| Leuprolide 7.5 mg / Degarelix 80 mg During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. | 69 |
| Leuprolide 7.5 mg / Degarelix 160 mg During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. | 65 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| CS21A (NCT00451958) | Adverse Event | 21 | 34 | 14 | 17 | 0 |
| CS21A (NCT00451958) | Lost to Follow-up | 6 | 5 | 1 | 1 | 0 |
| CS21A (NCT00451958) | Miscellaneous reasons | 28 | 27 | 17 | 14 | 0 |
| CS21A (NCT00451958) | Physician Decision | 2 | 4 | 4 | 4 | 0 |
| CS21A (NCT00451958) | Protocol Violation | 1 | 3 | 2 | 0 | 0 |
| CS21A (NCT00451958) | Withdrawal by Subject | 7 | 4 | 4 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Degarelix 160 mg / Degarelix 160 mg | Leuprolide 7.5 mg / Degarelix 80 mg | Leuprolide 7.5 mg / Degarelix 160 mg | Degarelix 80 mg / Degarelix 80 mg |
|---|---|---|---|---|---|
| Age Continuous | 71.1 years STANDARD_DEVIATION 8.29 | 71.1 years STANDARD_DEVIATION 8.25 | 72.4 years STANDARD_DEVIATION 9.46 | 71.4 years STANDARD_DEVIATION 8.24 | 70.1 years STANDARD_DEVIATION 7.62 |
| Body Mass Index | 26.8 kilogram per square meter STANDARD_DEVIATION 3.84 | 26.9 kilogram per square meter STANDARD_DEVIATION 3.79 | 26.9 kilogram per square meter STANDARD_DEVIATION 3.94 | 27.1 kilogram per square meter STANDARD_DEVIATION 3.67 | 26.4 kilogram per square meter STANDARD_DEVIATION 3.92 |
| Body Weight | 79.0 kilogram STANDARD_DEVIATION 12.5 | 79.2 kilogram STANDARD_DEVIATION 13.4 | 78.7 kilogram STANDARD_DEVIATION 11.3 | 80.0 kilogram STANDARD_DEVIATION 12.1 | 78.4 kilogram STANDARD_DEVIATION 12.6 |
| Gleason Score Gleason Score 2-4 | 51 participants | 17 participants | 8 participants | 11 participants | 15 participants |
| Gleason Score Gleason Score 5-6 | 124 participants | 44 participants | 25 participants | 18 participants | 37 participants |
| Gleason Score Gleason Score 7-10 | 208 participants | 63 participants | 36 participants | 36 participants | 73 participants |
| Region of Enrollment Canada | 18 participants | 5 participants | 5 participants | 4 participants | 4 participants |
| Region of Enrollment Czech Republic | 37 participants | 12 participants | 6 participants | 8 participants | 11 participants |
| Region of Enrollment Germany | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment Hungary | 26 participants | 9 participants | 5 participants | 5 participants | 7 participants |
| Region of Enrollment Mexico | 49 participants | 17 participants | 10 participants | 7 participants | 15 participants |
| Region of Enrollment Netherlands | 3 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Region of Enrollment Romania | 106 participants | 39 participants | 16 participants | 15 participants | 36 participants |
| Region of Enrollment Russian Federation | 64 participants | 19 participants | 6 participants | 13 participants | 26 participants |
| Region of Enrollment Ukraine | 31 participants | 10 participants | 7 participants | 3 participants | 11 participants |
| Region of Enrollment United Kingdom | 2 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 48 participants | 14 participants | 13 participants | 9 participants | 12 participants |
| Serum Prostate-Specific Antigen (PSA) Levels | 21.0 nanograms per milliliter | 22.5 nanograms per milliliter | 25.5 nanograms per milliliter | 14.0 nanograms per milliliter | 22.2 nanograms per milliliter |
| Serum Testosterone Levels | 4.23 nanograms per milliliter | 4.02 nanograms per milliliter | 4.32 nanograms per milliliter | 3.51 nanograms per milliliter | 4.63 nanograms per milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 385 Participants | 126 Participants | 69 Participants | 65 Participants | 125 Participants |
| Stage of Prostate Cancer Localised | 114 participants | 36 participants | 20 participants | 19 participants | 39 participants |
| Stage of Prostate Cancer Locally advanced | 132 participants | 44 participants | 18 participants | 24 participants | 46 participants |
| Stage of Prostate Cancer Metastatic | 75 participants | 22 participants | 21 participants | 9 participants | 23 participants |
| Stage of Prostate Cancer Not classifiable | 64 participants | 24 participants | 10 participants | 13 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 181 / 207 | 177 / 202 | 63 / 69 | 58 / 66 |
| serious Total, serious adverse events | 43 / 207 | 60 / 202 | 23 / 69 | 22 / 66 |
Outcome results
Primary
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
Time frame: Up to 4 years of treatment
Population: The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 11 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 1 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alkaline phosphatase (IU/L) >3xULN+25% increase | 4 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Creatinine (µmol/L) >=177 | 12 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 6 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 40 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 12 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 10 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Eosinophils (%) >=10 | 6 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Lymphocytes (%) <=10 | 8 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alkaline phosphatase (IU/L) >3xULN+25% increase | 5 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Eosinophils (%) >=10 | 7 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Creatinine (µmol/L) >=177 | 7 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 9 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 47 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 20 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Lymphocytes (%) <=10 | 9 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 15 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 9 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 6 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 9 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Lymphocytes (%) <=10 | 10 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 6 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Creatinine (µmol/L) >=177 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 22 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Eosinophils (%) >=10 | 1 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 1 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alkaline phosphatase (IU/L) >3xULN+25% increase | 4 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 3 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 17 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Lymphocytes (%) <=10 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 6 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 0 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alkaline phosphatase (IU/L) >3xULN+25% increase | 2 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Creatinine (µmol/L) >=177 | 2 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Eosinophils (%) >=10 | 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 table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Time frame: Up to 4 years of treatment
Population: The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 3 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 4 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 25 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 4 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 7 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 15 participants |
| Degarelix 80 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 3 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 24 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 3 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 6 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 6 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 4 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 14 participants |
| Degarelix 160 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 13 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 4 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 4 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 21 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 5 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 3 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 7 participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 7 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 5 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 6 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 3 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 4 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 2 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 3 participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 8 participants |
Secondary
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
Time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
Population: CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 28 | 100 percentage of participants |
| Degarelix 80 mg / Degarelix 80 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 1960 | 61.0 percentage of participants |
| Degarelix 80 mg / Degarelix 80 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 364 | 91.1 percentage of participants |
| Degarelix 160 mg / Degarelix 160 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 28 | 99.5 percentage of participants |
| Degarelix 160 mg / Degarelix 160 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 1960 | 58.7 percentage of participants |
| Degarelix 160 mg / Degarelix 160 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 364 | 85.8 percentage of participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 364 | 82.6 percentage of participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 28 | 98.6 percentage of participants |
| Leuprolide 7.5 mg / Degarelix 80 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 1960 | 50.7 percentage of participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 28 | 100 percentage of participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 1960 | 73.8 percentage of participants |
| Leuprolide 7.5 mg / Degarelix 160 mg | Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | Day 364 | 87.9 percentage of participants |
Secondary
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study.
Time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
Population: CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 84 | 99.5 percentage |
| Degarelix 80 mg / Degarelix 80 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 1876 | 82.0 percentage |
| Degarelix 80 mg / Degarelix 80 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 364 | 97.2 percentage |
| Degarelix 160 mg / Degarelix 160 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 84 | 100 percentage |
| Degarelix 160 mg / Degarelix 160 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 1876 | 87.7 percentage |
| Degarelix 160 mg / Degarelix 160 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 364 | 98.3 percentage |
| Leuprolide 7.5 mg / Degarelix 80 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 364 | 97. percentage |
| Leuprolide 7.5 mg / Degarelix 80 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 84 | 98.6 percentage |
| Leuprolide 7.5 mg / Degarelix 80 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 1876 | 84.1 percentage |
| Leuprolide 7.5 mg / Degarelix 160 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 84 | 97.6 percentage |
| Leuprolide 7.5 mg / Degarelix 160 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 1876 | 88.4 percentage |
| Leuprolide 7.5 mg / Degarelix 160 mg | Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | Day 364 | 96.0 percentage |
Secondary
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time frame: From time of switch to Day 56
Population: All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Baseline | 4.8 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 3 | 2.7 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 7 | 2.6 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 14 | 2.2 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 28 | 1.8 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 56 | 1.3 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 28 | 1.7 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Baseline | 4.4 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 14 | 2.3 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 3 | 2.8 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 56 | 1.55 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 7 | 2.6 International units/Liter (IU/L) |
Secondary
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time frame: From time of switch to Day 56
Population: All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 3 | 0.035 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 14 | 0.035 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 28 | 0.035 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Baseline | 0.035 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 56 | 0.035 International units/Liter (IU/L) |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 7 | 0.035 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 56 | 0.035 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Baseline | 0.035 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 3 | 0.035 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 7 | 0.035 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 28 | 0.035 International units/Liter (IU/L) |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 14 | 0.035 International units/Liter (IU/L) |
Secondary
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Time frame: From time of switch to Day 56
Population: All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Baseline | 0.4 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 3 | 0.4 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 7 | 0.35 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 14 | 0.4 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 28 | 0.4 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 56 | 0.35 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 28 | 0.5 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Baseline | 0.4 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 14 | 0.3 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 3 | 0.3 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 56 | 0.4 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 | Day 7 | 0.4 ng/mL |
Secondary
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
Time frame: From time of switch to Day 56
Population: All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Baseline | 0.076 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 3 | 0.084 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 7 | 0.076 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 14 | 0.085 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 28 | 0.074 ng/mL |
| Degarelix 80 mg / Degarelix 80 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 56 | 0.080 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 28 | 0.074 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Baseline | 0.074 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 14 | 0.073 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 3 | 0.068 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 56 | 0.077 ng/mL |
| Degarelix 160 mg / Degarelix 160 mg | Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 | Day 7 | 0.066 ng/mL |