Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
The study was a three-arm, active-control, multi-centre, parallel group study.
Interventions
DRUGDegarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
DRUGLeuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
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
Main Inclusion Criteria: * Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * Baseline testosterone \>1.5 ng/mL. * Life expectancy of at least 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 | 12 months | Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 | 3 days | This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication. |
| Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | Day 252, Day 255, and Day 259 | Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252. |
| Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Days 14 and 28 | Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression. |
| Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment | 2 weeks | A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14). |
| Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Baseline to Day 364 | Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported. |
| The Mean Value of QTc Interval as Measured by Electrocardiogram | 12 months | The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias. |
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | 12 months | Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline. |
| Participants Grouped by Time to Prostate-specific Antigen Failure | 12 months | The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. |
Countries
Canada, Czechia, Germany, Hungary, Mexico, Netherlands, Puerto Rico, Romania, Russia, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 240/160 mg Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days. | 202 |
| Degarelix 240/80 mg Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days. | 207 |
| Leuprolide 7.5 mg Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0. | 201 |
| Total | 610 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative errors | 2 | 4 | 5 |
| Overall Study | Adverse Event | 19 | 15 | 12 |
| Overall Study | Disease progression | 2 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 4 | 1 |
| Overall Study | Personal reasons | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 4 | 2 |
| Overall Study | Randomized but never received trial drug | 4 | 3 | 3 |
| Overall Study | Taking prohibited therapy | 2 | 3 | 2 |
| Overall Study | Trial drug errors | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 4 | 7 |
Baseline characteristics
| Characteristic | Degarelix 240/160 mg | Degarelix 240/80 mg | Leuprolide 7.5 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 165 Participants | 164 Participants | 163 Participants | 492 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 43 Participants | 38 Participants | 118 Participants |
| Age Continuous | 72 years FULL_RANGE 8.47 | 72 years FULL_RANGE 8.12 | 74 years FULL_RANGE 8.77 | 73 years FULL_RANGE 8.45 |
| Body Mass Index | 26.6 kilogram per square meter STANDARD_DEVIATION 3.7 | 26.7 kilogram per square meter STANDARD_DEVIATION 4.21 | 26.9 kilogram per square meter STANDARD_DEVIATION 3.86 | 26.8 kilogram per square meter STANDARD_DEVIATION 3.93 |
| Curative Intent No | 178 participants | 177 participants | 177 participants | 532 participants |
| Curative Intent Yes | 24 participants | 30 participants | 24 participants | 78 participants |
| Gleason Score 2-4 | 21 participants | 20 participants | 24 participants | 65 participants |
| Gleason Score 5-6 | 67 participants | 68 participants | 63 participants | 198 participants |
| Gleason Score 7 | 56 participants | 63 participants | 62 participants | 181 participants |
| Gleason Score 8-10 | 56 participants | 56 participants | 51 participants | 163 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 22 Participants | 18 Participants | 19 Participants | 59 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 17 Participants | 10 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 168 Participants | 171 Participants | 172 Participants | 511 Participants |
| Region of Enrollment Europe | 118 participants | 120 participants | 115 participants | 353 participants |
| Region of Enrollment North America | 84 participants | 87 participants | 86 participants | 257 participants |
| Serum Prostate-specific Antigen Levels | 19.9 nanogram per milliliter | 19.8 nanogram per milliliter | 19.0 nanogram per milliliter | 19.0 nanogram per milliliter |
| Serum Testosterone Levels | 3.78 nanogram per milliliter | 4.11 nanogram per milliliter | 3.84 nanogram per milliliter | 3.93 nanogram per milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 202 Participants | 207 Participants | 201 Participants | 610 Participants |
| Stage of Prostate Cancer Localized | 59 participants | 69 participants | 63 participants | 191 participants |
| Stage of Prostate Cancer Locally advanced | 62 participants | 64 participants | 52 participants | 178 participants |
| Stage of Prostate Cancer Metastatic | 41 participants | 37 participants | 47 participants | 125 participants |
| Stage of Prostate Cancer Not classifiable | 40 participants | 37 participants | 39 participants | 116 participants |
| Time Since Prostate Cancer Diagnosis | 485 days STANDARD_DEVIATION 1109 | 491 days STANDARD_DEVIATION 994 | 497 days STANDARD_DEVIATION 1088 | 491 days STANDARD_DEVIATION 1063 |
| Weight | 78.7 kilogram STANDARD_DEVIATION 13 | 79.8 kilogram STANDARD_DEVIATION 14.9 | 79.4 kilogram STANDARD_DEVIATION 12.2 | 79.3 kilogram STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 165 / — | 162 / — | 153 / — |
| serious Total, serious adverse events | 24 / — | 21 / — | 28 / — |
Outcome results
Primary
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
Time frame: 12 months
Population: Intent-to-treat (ITT) population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix 240/160 mg | Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 | 98.3 percentage of patients |
| Degarelix 240/80 mg | Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 | 97.2 percentage of patients |
| Leuprolide 7.5 mg | Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 | 96.4 percentage of patients |
Comparison: A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.97.5% CI: [-1.8, 5.7]
Comparison: A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.97.5% CI: [-3.2, 5]
Secondary
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252.
Time frame: Day 252, Day 255, and Day 259
Population: ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/160 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0.25-0.5 ng/mL | 0 participants |
| Degarelix 240/160 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0-0.25 ng/mL | 91 participants |
| Degarelix 240/160 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | <=-0.25 ng/mL | 1 participants |
| Degarelix 240/160 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >-0.25-0 ng/mL | 84 participants |
| Degarelix 240/160 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0.5 ng/mL | 0 participants |
| Degarelix 240/80 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0-0.25 ng/mL | 90 participants |
| Degarelix 240/80 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | <=-0.25 ng/mL | 3 participants |
| Degarelix 240/80 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >-0.25-0 ng/mL | 85 participants |
| Degarelix 240/80 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0.25-0.5 ng/mL | 0 participants |
| Degarelix 240/80 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0.5 ng/mL | 0 participants |
| Leuprolide 7.5 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0.5 ng/mL | 3 participants |
| Leuprolide 7.5 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0.25-0.5 ng/mL | 5 participants |
| Leuprolide 7.5 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | <=-0.25 ng/mL | 0 participants |
| Leuprolide 7.5 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >0-0.25 ng/mL | 122 participants |
| Leuprolide 7.5 mg | Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | >-0.25-0 ng/mL | 49 participants |
Secondary
Participants Grouped by Time to Prostate-specific Antigen Failure
The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.
Time frame: 12 months
Population: ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-336 (patients at risk=149, 156, 150) | 26 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-252 (patients at risk=165, 169, 168) | 16 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-168 (patients at risk=179, 185, 180) | 7 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-84 (patients at risk=190, 193, 190) | 1 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-224 (patients at risk=168, 175, 173) | 14 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-196 (patients at risk=173, 181, 175) | 11 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-28 (patients at risk=193, 201, 194) | 1 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-56 (patients at risk=192, 197, 192) | 1 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-308 (patients at risk=153, 161, 156) | 23 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-112 (patients at risk=190, 189, 188) | 1 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-364 (patients at risk=149, 155, 148) | 26 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-280 (patients at risk=157, 165, 163) | 20 participants |
| Degarelix 240/160 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-140 (patients at risk=187, 187, 182) | 2 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-196 (patients at risk=173, 181, 175) | 4 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-28 (patients at risk=193, 201, 194) | 0 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-56 (patients at risk=192, 197, 192) | 0 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-84 (patients at risk=190, 193, 190) | 0 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-112 (patients at risk=190, 189, 188) | 1 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-140 (patients at risk=187, 187, 182) | 2 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-168 (patients at risk=179, 185, 180) | 4 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-224 (patients at risk=168, 175, 173) | 7 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-252 (patients at risk=165, 169, 168) | 9 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-280 (patients at risk=157, 165, 163) | 11 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-308 (patients at risk=153, 161, 156) | 12 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-336 (patients at risk=149, 156, 150) | 15 participants |
| Degarelix 240/80 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-364 (patients at risk=149, 155, 148) | 16 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-252 (patients at risk=165, 169, 168) | 14 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-112 (patients at risk=190, 189, 188) | 3 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-336 (patients at risk=149, 156, 150) | 24 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-280 (patients at risk=157, 165, 163) | 18 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-84 (patients at risk=190, 193, 190) | 1 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-28 (patients at risk=193, 201, 194) | 1 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-308 (patients at risk=153, 161, 156) | 21 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-196 (patients at risk=173, 181, 175) | 11 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-168 (patients at risk=179, 185, 180) | 9 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-56 (patients at risk=192, 197, 192) | 1 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-224 (patients at risk=168, 175, 173) | 12 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-140 (patients at risk=187, 187, 182) | 7 participants |
| Leuprolide 7.5 mg | Participants Grouped by Time to Prostate-specific Antigen Failure | Day 0-364 (patients at risk=149, 155, 148) | 26 participants |
95% CI: [79.8, 90.1]
95% CI: [85.9, 94.5]
95% CI: [79.9, 90.2]
Secondary
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.
Time frame: Baseline to Day 364
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Urine Protein (>=2 units from baseline) | 65 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Serum Urea Nitrogen (>=10.7 mmol/L) | 48 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Haematocrit (<=0.37 ratio) | 73 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Haemoglobin (<=115 g/L) | 32 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Urine Bacteria (0 at baseline and >0 on treatment) | 96 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Serum Urea Nitrogen (>=10.7 mmol/L) | 41 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Haematocrit (<=0.37 ratio) | 80 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Haemoglobin (<=115 g/L) | 45 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Urine Protein (>=2 units from baseline) | 64 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Urine Bacteria (0 at baseline and >0 on treatment) | 105 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Urine Bacteria (0 at baseline and >0 on treatment) | 107 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Urine Protein (>=2 units from baseline) | 63 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Haematocrit (<=0.37 ratio) | 73 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Serum Urea Nitrogen (>=10.7 mmol/L) | 50 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Haemoglobin (<=115 g/L) | 38 participants |
Secondary
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
Time frame: 12 months
Population: ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 12 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 12 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 5 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 24 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 20 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 8 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 5 participants |
| Degarelix 240/160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 16 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 8 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 6 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 15 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 10 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 13 participants |
| Degarelix 240/80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 7 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 8 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 6 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 23 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 9 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 23 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 9 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Leuprolide 7.5 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 10 participants |
Secondary
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.
Time frame: Days 14 and 28
Population: ITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 240/160 mg | Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Day 14 | -64.6 percent change |
| Degarelix 240/160 mg | Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Day 28 | -82.3 percent change |
| Degarelix 240/80 mg | Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Day 14 | -63.4 percent change |
| Degarelix 240/80 mg | Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Day 28 | -84.9 percent change |
| Leuprolide 7.5 mg | Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Day 14 | -17.9 percent change |
| Leuprolide 7.5 mg | Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Day 28 | -66.7 percent change |
Comparison: Percentage change from baseline to Day 14p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Percentage change from baseline to Day 14p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Percentage change from baseline to Day 28p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Percentage change from baseline to Day 28p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
Time frame: 3 days
Population: ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix 240/160 mg | Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 | 95.5 percentage of patients |
| Degarelix 240/80 mg | Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 | 96.1 percentage of patients |
| Leuprolide 7.5 mg | Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 | 0 percentage of patients |
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
Secondary
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).
Time frame: 2 weeks
Population: ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix 240/160 mg | Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment | 0.5 percentage of patients |
| Degarelix 240/80 mg | Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment | 0.0 percentage of patients |
| Leuprolide 7.5 mg | Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment | 80.1 percentage of patients |
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
Secondary
The Mean Value of QTc Interval as Measured by Electrocardiogram
The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.
Time frame: 12 months
Population: ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240/160 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | Day 3 (n=195, 204, 197) | 404 milliseconds | Standard Deviation 22.1 |
| Degarelix 240/160 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | Baseline Day 0 (n=202, 207, 201) | 403 milliseconds | Standard Deviation 20.2 |
| Degarelix 240/160 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | End of study 12 months (n=202, 207, 201) | 415 milliseconds | Standard Deviation 21.7 |
| Degarelix 240/80 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | Day 3 (n=195, 204, 197) | 411 milliseconds | Standard Deviation 23.5 |
| Degarelix 240/80 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | Baseline Day 0 (n=202, 207, 201) | 407 milliseconds | Standard Deviation 21.6 |
| Degarelix 240/80 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | End of study 12 months (n=202, 207, 201) | 420 milliseconds | Standard Deviation 22.3 |
| Leuprolide 7.5 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | Baseline Day 0 (n=202, 207, 201) | 404 milliseconds | Standard Deviation 19.4 |
| Leuprolide 7.5 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | End of study 12 months (n=202, 207, 201) | 419 milliseconds | Standard Deviation 23.3 |
| Leuprolide 7.5 mg | The Mean Value of QTc Interval as Measured by Electrocardiogram | Day 3 (n=195, 204, 197) | 405 milliseconds | Standard Deviation 23 |