Trial Outcomes & Findings for A Long Term Safety Study of Degarelix in Patients With Prostate Cancer (NCT NCT00967018)
NCT ID: NCT00967018
Last Updated: 2013-01-03
Results Overview
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Up to 22.5 months
Results posted on
2013-01-03
Participant Flow
The patients were recruited from 16 sites in Belgium, France, Italy, Spain, Sweden and Turkey. The study was conducted between 31 August 2009 (FPFV) and 29 November 2011 (LPLV).
Participant milestones
| Measure |
Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Overall Study
STARTED
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77
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Overall Study
COMPLETED
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56
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|
Overall Study
NOT COMPLETED
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21
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Reasons for withdrawal
| Measure |
Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Overall Study
Adverse Event
|
2
|
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Overall Study
Physician Decision
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Miscellaneous Reasons
|
9
|
Baseline Characteristics
A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix
n=77 Participants
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Age Continuous
|
71.9 years
STANDARD_DEVIATION 7.59 • n=99 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=99 Participants
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|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
|
Region of Enrollment
France
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2 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=99 Participants
|
|
Region of Enrollment
Turkey
|
14 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
35 participants
n=99 Participants
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|
Region of Enrollment
Sweden
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13 participants
n=99 Participants
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|
Body Mass Index (BMI)
|
27.2 kilogram per square meter
STANDARD_DEVIATION 4.2 • n=99 Participants
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|
Gleason Score
Gleason Score 2-4
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1 Participants
n=99 Participants
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|
Gleason Score
Gleason Score 5-6
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18 Participants
n=99 Participants
|
|
Gleason Score
Gleason Score 7-10
|
58 Participants
n=99 Participants
|
|
Stage of Prostate Cancer
Localized
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36 Participants
n=99 Participants
|
|
Stage of Prostate Cancer
Locally Advanced
|
19 Participants
n=99 Participants
|
|
Stage of Prostate Cancer
Metastatic
|
15 Participants
n=99 Participants
|
|
Stage of Prostate Cancer
Not Classifiable
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 22.5 monthsThe figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Outcome measures
| Measure |
Degarelix
n=77 Participants
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Red blood cell count (10^12/L) <=3.5
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3 Participants
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|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Platelet count (10^9/L) <=75
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1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Haematocrit (Ratio) <=0.37
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24 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Haemoglobin (g/L) <=115
|
6 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-White blood cell count (10^9/L) <=2.8
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-White blood cell count (10^9/L) >=16.0
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
S-Aspartate aminotransferase (IU/L) >3xULN
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
S-Potassium (mmol/L) >=5.8
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
S-Urea nitrogen (mmol/L) >=10.7
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 22.5 monthsThis outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Outcome measures
| Measure |
Degarelix
n=77 Participants
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Systolic blood pressure <=90 and decrease >=20
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1 Participants
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Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
1 Participants
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|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Diastolic blood pressure >=105 and increase >=15
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Systolic blood pressure >=180 and increase >=20
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0 Participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Heart rate <=50 and decrease >=15
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0 Participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Heart rate >=120 and increase >=15
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1 Participants
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|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Body weight decrease of >=7 percent
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0 Participants
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|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Body weight increase of >=7 percent
|
2 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to 72 weeksPopulation: The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
Outcome measures
| Measure |
Degarelix
n=77 Participants
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Serum Levels of Prostate Specific Antigen (PSA)Over Time
Baseline (0 weeks)
|
1.4 ng/mL
Interval 0.05 to 431.3
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Serum Levels of Prostate Specific Antigen (PSA)Over Time
Week 24
|
0.75 ng/mL
Interval 0.05 to 58.5
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Serum Levels of Prostate Specific Antigen (PSA)Over Time
Week 36
|
0.6 ng/mL
Interval 0.05 to 508.8
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Serum Levels of Prostate Specific Antigen (PSA)Over Time
Week 48
|
0.55 ng/mL
Interval 0.05 to 606.5
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Serum Levels of Prostate Specific Antigen (PSA)Over Time
Week 72
|
1.9 ng/mL
Interval 0.05 to 168.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to week 72Population: The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
Outcome measures
| Measure |
Degarelix
n=77 Participants
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Serum Levels of Testosterone Over Time
Baseline (Week 0)
|
0.05 ng/mL
Interval 0.05 to 8.07
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|
Serum Levels of Testosterone Over Time
Week 24
|
0.05 ng/mL
Interval 0.05 to 0.54
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|
Serum Levels of Testosterone Over Time
Week 36
|
0.05 ng/mL
Interval 0.05 to 0.26
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|
Serum Levels of Testosterone Over Time
Week 48
|
0.08 ng/mL
Interval 0.05 to 0.62
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|
Serum Levels of Testosterone Over Time
Week 72
|
0.12 ng/mL
Interval 0.05 to 0.22
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Adverse Events
Degarelix
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix
n=77 participants at risk
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Eye disorders
Vitreous haemorrhage
|
1.3%
1/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
General disorders
Chest pain
|
1.3%
1/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Nervous system disorders
Convulsion
|
1.3%
1/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
Other adverse events
| Measure |
Degarelix
n=77 participants at risk
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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|---|---|
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Gastrointestinal disorders
Haematochezia
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
General disorders
Injection site inflammation
|
9.1%
7/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
General disorders
Chills
|
5.2%
4/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
General disorders
Injection site pain
|
5.2%
4/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
General disorders
Chest pain
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Infections and infestations
Influenza
|
7.8%
6/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Infections and infestations
Viral upper respiratory tract
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
4/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Nervous system disorders
Dizziness
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Nervous system disorders
Syncope
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
|
|
Vascular disorders
Hot flush
|
2.6%
2/77 • Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
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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. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER