Trial Outcomes & Findings for The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer (NCT NCT00295750)
NCT ID: NCT00295750
Last Updated: 2012-12-19
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
620 participants
Primary outcome timeframe
12 months
Results posted on
2012-12-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Leuprolide 7.5 mg
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Overall Study
STARTED
|
206
|
210
|
204
|
|
Overall Study
Intent-to-treat (ITT) Population
|
202
|
207
|
201
|
|
Overall Study
COMPLETED
|
163
|
169
|
172
|
|
Overall Study
NOT COMPLETED
|
43
|
41
|
32
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Leuprolide 7.5 mg
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
19
|
15
|
12
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
1
|
|
Overall Study
Taking prohibited therapy
|
2
|
3
|
2
|
|
Overall Study
Administrative errors
|
2
|
4
|
5
|
|
Overall Study
Trial drug errors
|
1
|
1
|
0
|
|
Overall Study
Disease progression
|
2
|
1
|
0
|
|
Overall Study
Personal reasons
|
0
|
1
|
0
|
|
Overall Study
Randomized but never received trial drug
|
4
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
7
|
|
Overall Study
Protocol Violation
|
2
|
4
|
2
|
Baseline Characteristics
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
Total
n=610 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Gleason Score
7
|
56 participants
n=5 Participants
|
63 participants
n=7 Participants
|
62 participants
n=5 Participants
|
181 participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
165 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
492 Participants
n=4 Participants
|
|
Gleason Score
8-10
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
51 participants
n=5 Participants
|
163 participants
n=4 Participants
|
|
Age Continuous
|
72 years
FULL_RANGE 8.47 • n=5 Participants
|
72 years
FULL_RANGE 8.12 • n=7 Participants
|
74 years
FULL_RANGE 8.77 • n=5 Participants
|
73 years
FULL_RANGE 8.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
610 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
168 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
511 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
North America
|
84 participants
n=5 Participants
|
87 participants
n=7 Participants
|
86 participants
n=5 Participants
|
257 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
118 participants
n=5 Participants
|
120 participants
n=7 Participants
|
115 participants
n=5 Participants
|
353 participants
n=4 Participants
|
|
Curative Intent
Yes
|
24 participants
n=5 Participants
|
30 participants
n=7 Participants
|
24 participants
n=5 Participants
|
78 participants
n=4 Participants
|
|
Curative Intent
No
|
178 participants
n=5 Participants
|
177 participants
n=7 Participants
|
177 participants
n=5 Participants
|
532 participants
n=4 Participants
|
|
Gleason Score
2-4
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
24 participants
n=5 Participants
|
65 participants
n=4 Participants
|
|
Gleason Score
5-6
|
67 participants
n=5 Participants
|
68 participants
n=7 Participants
|
63 participants
n=5 Participants
|
198 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Localized
|
59 participants
n=5 Participants
|
69 participants
n=7 Participants
|
63 participants
n=5 Participants
|
191 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Locally advanced
|
62 participants
n=5 Participants
|
64 participants
n=7 Participants
|
52 participants
n=5 Participants
|
178 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Metastatic
|
41 participants
n=5 Participants
|
37 participants
n=7 Participants
|
47 participants
n=5 Participants
|
125 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Not classifiable
|
40 participants
n=5 Participants
|
37 participants
n=7 Participants
|
39 participants
n=5 Participants
|
116 participants
n=4 Participants
|
|
Body Mass Index
|
26.6 kilogram per square meter
STANDARD_DEVIATION 3.70 • n=5 Participants
|
26.7 kilogram per square meter
STANDARD_DEVIATION 4.21 • n=7 Participants
|
26.9 kilogram per square meter
STANDARD_DEVIATION 3.86 • n=5 Participants
|
26.8 kilogram per square meter
STANDARD_DEVIATION 3.93 • n=4 Participants
|
|
Serum Prostate-specific Antigen Levels
|
19.9 nanogram per milliliter
n=5 Participants
|
19.8 nanogram per milliliter
n=7 Participants
|
19.0 nanogram per milliliter
n=5 Participants
|
19.0 nanogram per milliliter
n=4 Participants
|
|
Serum Testosterone Levels
|
3.78 nanogram per milliliter
n=5 Participants
|
4.11 nanogram per milliliter
n=7 Participants
|
3.84 nanogram per milliliter
n=5 Participants
|
3.93 nanogram per milliliter
n=4 Participants
|
|
Time Since Prostate Cancer Diagnosis
|
485 days
STANDARD_DEVIATION 1109 • n=5 Participants
|
491 days
STANDARD_DEVIATION 994 • n=7 Participants
|
497 days
STANDARD_DEVIATION 1088 • n=5 Participants
|
491 days
STANDARD_DEVIATION 1063 • n=4 Participants
|
|
Weight
|
78.7 kilogram
STANDARD_DEVIATION 13.0 • n=5 Participants
|
79.8 kilogram
STANDARD_DEVIATION 14.9 • n=7 Participants
|
79.4 kilogram
STANDARD_DEVIATION 12.2 • n=5 Participants
|
79.3 kilogram
STANDARD_DEVIATION 13.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat (ITT) population.
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%.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
|
98.3 percentage of patients
Interval 94.8 to 99.4
|
97.2 percentage of patients
Interval 93.5 to 98.8
|
96.4 percentage of patients
Interval 92.5 to 98.2
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
|
0.5 percentage of patients
Interval 0.0 to 2.7
|
0.0 percentage of patients
Interval 0.0 to 1.8
|
80.1 percentage of patients
Interval 73.9 to 85.4
|
SECONDARY outcome
Timeframe: 3 daysPopulation: ITT population.
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
|
95.5 percentage of patients
Interval 91.7 to 97.9
|
96.1 percentage of patients
Interval 92.5 to 98.3
|
0 percentage of patients
Interval 0.0 to 1.8
|
SECONDARY outcome
Timeframe: Day 252, Day 255, and Day 259Population: ITT population who had blood samples drawn on 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.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=176 Participants
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.
|
Degarelix 240/80 mg
n=178 Participants
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.
|
Leuprolide 7.5 mg
n=179 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
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
|
3 participants
|
0 participants
|
|
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
|
85 participants
|
49 participants
|
|
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
|
90 participants
|
122 participants
|
|
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
|
0 participants
|
5 participants
|
|
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
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Days 14 and 28Population: ITT population.
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.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Day 14
|
-64.6 percent change
Interval -77.8 to -40.8
|
-63.4 percent change
Interval -77.1 to -48.4
|
-17.9 percent change
Interval -35.5 to -5.2
|
|
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Day 28
|
-82.3 percent change
Interval -91.4 to -68.3
|
-84.9 percent change
Interval -91.6 to -73.2
|
-66.7 percent change
Interval -81.3 to -47.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with 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.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-28 (patients at risk=193, 201, 194)
|
1 participants
|
0 participants
|
1 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-56 (patients at risk=192, 197, 192)
|
1 participants
|
0 participants
|
1 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-84 (patients at risk=190, 193, 190)
|
1 participants
|
0 participants
|
1 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-112 (patients at risk=190, 189, 188)
|
1 participants
|
1 participants
|
3 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-140 (patients at risk=187, 187, 182)
|
2 participants
|
2 participants
|
7 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-168 (patients at risk=179, 185, 180)
|
7 participants
|
4 participants
|
9 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-196 (patients at risk=173, 181, 175)
|
11 participants
|
4 participants
|
11 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-224 (patients at risk=168, 175, 173)
|
14 participants
|
7 participants
|
12 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-252 (patients at risk=165, 169, 168)
|
16 participants
|
9 participants
|
14 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-280 (patients at risk=157, 165, 163)
|
20 participants
|
11 participants
|
18 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-308 (patients at risk=153, 161, 156)
|
23 participants
|
12 participants
|
21 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-336 (patients at risk=149, 156, 150)
|
26 participants
|
15 participants
|
24 participants
|
|
Participants Grouped by Time to Prostate-specific Antigen Failure
Day 0-364 (patients at risk=149, 155, 148)
|
26 participants
|
16 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline to Day 364Population: ITT population
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.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Haematocrit (<=0.37 ratio)
|
73 participants
|
80 participants
|
73 participants
|
|
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Haemoglobin (<=115 g/L)
|
32 participants
|
45 participants
|
38 participants
|
|
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Serum Urea Nitrogen (>=10.7 mmol/L)
|
48 participants
|
41 participants
|
50 participants
|
|
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Urine Protein (>=2 units from baseline)
|
65 participants
|
64 participants
|
63 participants
|
|
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Urine Bacteria (0 at baseline and >0 on treatment)
|
96 participants
|
105 participants
|
107 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
The Mean Value of QTc Interval as Measured by Electrocardiogram
Baseline Day 0 (n=202, 207, 201)
|
403 milliseconds
Standard Deviation 20.2
|
407 milliseconds
Standard Deviation 21.6
|
404 milliseconds
Standard Deviation 19.4
|
|
The Mean Value of QTc Interval as Measured by Electrocardiogram
Day 3 (n=195, 204, 197)
|
404 milliseconds
Standard Deviation 22.1
|
411 milliseconds
Standard Deviation 23.5
|
405 milliseconds
Standard Deviation 23.0
|
|
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
|
420 milliseconds
Standard Deviation 22.3
|
419 milliseconds
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Degarelix 240/160 mg
n=202 Participants
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.
|
Degarelix 240/80 mg
n=207 Participants
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.
|
Leuprolide 7.5 mg
n=201 Participants
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure <=90 and decrease >=20
|
12 participants
|
8 participants
|
6 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure >=180 and increase >=20
|
20 participants
|
16 participants
|
23 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
12 participants
|
10 participants
|
9 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure >=105 and increase >=15
|
5 participants
|
13 participants
|
8 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate <=50 and decrease >=15
|
8 participants
|
7 participants
|
9 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate >=120 and increase >=15
|
1 participants
|
0 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight decrease of >=7 percent
|
5 participants
|
6 participants
|
10 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight increase of >=7 percent
|
24 participants
|
15 participants
|
23 participants
|
Adverse Events
Degarelix 240/160 mg
Serious events: 24 serious events
Other events: 165 other events
Deaths: 0 deaths
Degarelix 240/80 mg
Serious events: 21 serious events
Other events: 162 other events
Deaths: 0 deaths
Leuprolide 7.5 mg
Serious events: 28 serious events
Other events: 153 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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.
|
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.
|
Leuprolide 7.5 mg
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
2/202 • Number of events 2
|
0.00%
0/207
|
1.5%
3/201 • Number of events 3
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/202
|
0.97%
2/207 • Number of events 2
|
0.00%
0/201
|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Angina unstable
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
1.00%
2/201 • Number of events 2
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.50%
1/202 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
General disorders
Pyrexia
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.50%
1/202 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Infections and infestations
Ear infection
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Infections and infestations
Lobar pneumonia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Infections and infestations
Pneumonia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Infections and infestations
Post procedural cellulitis
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Injury, poisoning and procedural complications
Overdose
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Investigations
Prostate examination abnormal
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Investigations
Electrocardiogram (ECG) signs of myocardial ischaemia
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/202 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant lymphoma unclassifiable
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Linitis plastica
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Nervous system disorders
Hyperkinesia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.99%
2/202 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Renal and urinary disorders
Calculus bladder
|
0.50%
1/202 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/202
|
0.97%
2/207 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.99%
2/202 • Number of events 2
|
0.00%
0/207
|
1.00%
2/201 • Number of events 2
|
|
Renal and urinary disorders
Bladder obstruction
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/202 • Number of events 2
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.50%
1/202 • Number of events 2
|
0.00%
0/207
|
0.00%
0/201
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.00%
0/201
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/202
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Vascular disorders
Hypotension
|
0.00%
0/202
|
0.48%
1/207 • Number of events 1
|
0.00%
0/201
|
|
Vascular disorders
Orthostatic hypotension
|
0.50%
1/202 • Number of events 1
|
0.00%
0/207
|
0.50%
1/201 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/202
|
0.00%
0/207
|
1.00%
2/201 • Number of events 3
|
Other adverse events
| Measure |
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.
|
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.
|
Leuprolide 7.5 mg
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.4%
11/202 • Number of events 15
|
4.3%
9/207 • Number of events 10
|
4.0%
8/201 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
3.0%
6/202 • Number of events 6
|
5.3%
11/207 • Number of events 12
|
5.0%
10/201 • Number of events 11
|
|
General disorders
Injection site pain
|
30.2%
61/202 • Number of events 108
|
28.0%
58/207 • Number of events 114
|
0.50%
1/201 • Number of events 1
|
|
General disorders
Injection site erythema
|
23.8%
48/202 • Number of events 63
|
17.4%
36/207 • Number of events 56
|
0.00%
0/201
|
|
General disorders
Injection site swelling
|
6.9%
14/202 • Number of events 23
|
6.3%
13/207 • Number of events 17
|
0.00%
0/201
|
|
General disorders
Fatigue
|
6.4%
13/202 • Number of events 14
|
3.4%
7/207 • Number of events 11
|
6.5%
13/201 • Number of events 14
|
|
General disorders
Injection site induration
|
5.4%
11/202 • Number of events 14
|
3.9%
8/207 • Number of events 11
|
0.00%
0/201
|
|
General disorders
Injection site nodule
|
6.4%
13/202 • Number of events 24
|
2.9%
6/207 • Number of events 8
|
0.00%
0/201
|
|
General disorders
Chills
|
3.5%
7/202 • Number of events 9
|
5.3%
11/207 • Number of events 19
|
0.00%
0/201
|
|
Infections and infestations
Urinary tract infection
|
1.5%
3/202 • Number of events 3
|
4.8%
10/207 • Number of events 14
|
9.0%
18/201 • Number of events 25
|
|
Investigations
Weight increased
|
10.9%
22/202 • Number of events 22
|
8.7%
18/207 • Number of events 18
|
11.9%
24/201 • Number of events 24
|
|
Investigations
Alanine aminotransferase increased
|
8.4%
17/202 • Number of events 17
|
9.7%
20/207 • Number of events 22
|
5.5%
11/201 • Number of events 11
|
|
Investigations
Aspartate aminostransferase increased
|
5.0%
10/202 • Number of events 11
|
5.3%
11/207 • Number of events 12
|
3.0%
6/201 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.9%
12/202 • Number of events 12
|
3.4%
7/207 • Number of events 7
|
2.5%
5/201 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
12/202 • Number of events 13
|
5.8%
12/207 • Number of events 12
|
8.5%
17/201 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
6/202 • Number of events 6
|
5.3%
11/207 • Number of events 12
|
9.0%
18/201 • Number of events 20
|
|
Vascular disorders
Hot flush
|
26.2%
53/202 • Number of events 59
|
25.6%
53/207 • Number of events 71
|
21.4%
43/201 • Number of events 50
|
|
Vascular disorders
Hypertension
|
6.9%
14/202 • Number of events 16
|
5.3%
11/207 • Number of events 12
|
4.0%
8/201 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
- Publication restrictions are in place
Restriction type: OTHER