Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen ablation therapy
Brief summary
To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients
Detailed description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked YES). The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.
Interventions
DRUGDegarelix
Given as a subcutaneous injection once every 4 weeks.
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
* Has completed study treatment in study FE200486 CS02. * Has completed visit 16 in study FE200486 CS02. * Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Function Tests | 3 years | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN. |
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | 3 years | Vital signs and body weight included incidence of markedly abnormal changes 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. |
Secondary
| Measure | Time frame |
|---|---|
| Serum Levels of Testosterone After 1, 2, and 3 Years | 3 years |
Participant flow
Recruitment details
Participants who responded to degarelix in FE200486 CS02 (NCT00819247) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the UK or until the study was discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 80/80 + 40 In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. | 43 |
| Degarelix 40/40 + 40 In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. | 46 |
| Degarelix 80 + 20 In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. | 40 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reasons | 0 | 1 | 0 |
| Overall Study | Adverse Event | 2 | 8 | 4 |
| Overall Study | Death | 0 | 2 | 0 |
| Overall Study | Disease progression | 0 | 3 | 1 |
| Overall Study | Insufficient PSA and testosterone suppr | 0 | 0 | 3 |
| Overall Study | Insufficient testosterone suppr | 12 | 12 | 21 |
| Overall Study | Lost to Follow-up | 3 | 0 | 0 |
| Overall Study | Low prostate specific antigen suppr | 16 | 14 | 5 |
| Overall Study | Protocol Violation | 1 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Degarelix 80/80 + 40 | Degarelix 40/40 + 40 | Degarelix 80 + 20 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 41 Participants | 33 Participants | 111 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
| Age Continuous | 72.4 years STANDARD_DEVIATION 6.6 | 73.7 years STANDARD_DEVIATION 7.22 | 71.8 years STANDARD_DEVIATION 7.08 | 72.7 years STANDARD_DEVIATION 6.97 |
| Body mass index | 26.6 kilogram per square meter STANDARD_DEVIATION 4.15 | 26.6 kilogram per square meter STANDARD_DEVIATION 4.06 | 25.9 kilogram per square meter STANDARD_DEVIATION 3.93 | 26.4 kilogram per square meter STANDARD_DEVIATION 3.93 |
| Gleason score 2-4 | 3 participants | 4 participants | 2 participants | 9 participants |
| Gleason score 5-6 | 11 participants | 7 participants | 11 participants | 29 participants |
| Gleason score 7-10 | 28 participants | 34 participants | 26 participants | 88 participants |
| Gleason score Unknown | 1 participants | 1 participants | 1 participants | 3 participants |
| Number of Participants at Each Stage of Prostate Cancer Localized | 8 participants | 9 participants | 5 participants | 22 participants |
| Number of Participants at Each Stage of Prostate Cancer Locally advanced | 21 participants | 21 participants | 18 participants | 60 participants |
| Number of Participants at Each Stage of Prostate Cancer Metastatic | 11 participants | 14 participants | 17 participants | 42 participants |
| Number of Participants at Each Stage of Prostate Cancer Not classifiable | 3 participants | 2 participants | 0 participants | 5 participants |
| Number of Participants With Curative Intent No | 43 participants | 44 participants | 39 participants | 126 participants |
| Number of Participants With Curative Intent Yes | 0 participants | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Afro-Carribean | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 1 participants | 3 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Indian | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 42 participants | 43 participants | 37 participants | 122 participants |
| Serum testosterone levels | 3.74 nanogram per milliliter | 4.11 nanogram per milliliter | 4.70 nanogram per milliliter | 3.98 nanogram per milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 43 Participants | 46 Participants | 40 Participants | 129 Participants |
| Weight | 77.6 kilogram STANDARD_DEVIATION 11.4 | 78.5 kilogram STANDARD_DEVIATION 14.2 | 76.3 kilogram STANDARD_DEVIATION 9.78 | 77.5 kilogram STANDARD_DEVIATION 12 |
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 | 42 / — | 40 / — | 35 / — |
| serious Total, serious adverse events | 10 / — | 14 / — | 10 / — |
Outcome results
Primary
Liver Function Tests
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Time frame: 3 years
Population: The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80/80 + 40 | Liver Function Tests | ALAT >3x ULN | 2 participants |
| Degarelix 80/80 + 40 | Liver Function Tests | Abnormal bilirubin | 3 participants |
| Degarelix 80/80 + 40 | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 18 participants |
| Degarelix 80/80 + 40 | Liver Function Tests | Abnormal aspartate aminotransferase | 23 participants |
| Degarelix 80/80 + 40 | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 40/40 + 40 | Liver Function Tests | Abnormal bilirubin | 4 participants |
| Degarelix 40/40 + 40 | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 16 participants |
| Degarelix 40/40 + 40 | Liver Function Tests | Abnormal aspartate aminotransferase | 22 participants |
| Degarelix 40/40 + 40 | Liver Function Tests | ALAT >3x ULN | 2 participants |
| Degarelix 40/40 + 40 | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 80 + 20 | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 1 participants |
| Degarelix 80 + 20 | Liver Function Tests | ALAT >3x ULN | 1 participants |
| Degarelix 80 + 20 | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 16 participants |
| Degarelix 80 + 20 | Liver Function Tests | Abnormal bilirubin | 5 participants |
| Degarelix 80 + 20 | Liver Function Tests | Abnormal aspartate aminotransferase | 17 participants |
Primary
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes 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: 3 years
Population: These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 1 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 8 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 5 participants |
| Degarelix 80/80 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 17 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 4 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 7 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 2 participants |
| Degarelix 40/40 + 40 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 14 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 2 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 5 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 2 participants |
| Degarelix 80 + 20 | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 15 participants |
Secondary
Serum Levels of Testosterone After 1, 2, and 3 Years
Time frame: 3 years
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 80/80 + 40 | Serum Levels of Testosterone After 1, 2, and 3 Years | 2 years (n=16,9,8) | 0.143 nanogram per milliliter |
| Degarelix 80/80 + 40 | Serum Levels of Testosterone After 1, 2, and 3 Years | 1 year (n=25,17,14) | 0.120 nanogram per milliliter |
| Degarelix 80/80 + 40 | Serum Levels of Testosterone After 1, 2, and 3 Years | 3 years (n=8,5,6) | 0.104 nanogram per milliliter |
| Degarelix 40/40 + 40 | Serum Levels of Testosterone After 1, 2, and 3 Years | 2 years (n=16,9,8) | 0.133 nanogram per milliliter |
| Degarelix 40/40 + 40 | Serum Levels of Testosterone After 1, 2, and 3 Years | 1 year (n=25,17,14) | 0.086 nanogram per milliliter |
| Degarelix 40/40 + 40 | Serum Levels of Testosterone After 1, 2, and 3 Years | 3 years (n=8,5,6) | 0.132 nanogram per milliliter |
| Degarelix 80 + 20 | Serum Levels of Testosterone After 1, 2, and 3 Years | 1 year (n=25,17,14) | 0.170 nanogram per milliliter |
| Degarelix 80 + 20 | Serum Levels of Testosterone After 1, 2, and 3 Years | 3 years (n=8,5,6) | 0.198 nanogram per milliliter |
| Degarelix 80 + 20 | Serum Levels of Testosterone After 1, 2, and 3 Years | 2 years (n=16,9,8) | 0.305 nanogram per milliliter |