Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen ablation therapy
Brief summary
Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.
Detailed description
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
Interventions
DRUGDegarelix
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
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
Each patient must meet the following inclusion criteria before entry into the study: * Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.
Exclusion criteria
Any patient meeting any of the following
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 participants in each group with normal baseline and markedly abnormal value post-baseline. |
Countries
United States
Participant flow
Recruitment details
Participants who responded to degarelix in FE200486 CS06 (NCT00117949) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the US or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS06.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 40 mg Degarelix 40 mg (10 mg/mL) | 10 |
| Degarelix 80 mg Degarelix 80 mg (20 mg/mL) | 24 |
| Degarelix 120 mg Degarelix 120 mg (30 mg/mL) | 24 |
| Degarelix 160 mg Degarelix 160 mg (40 mg/mL) | 24 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 0 |
| Overall Study | Hepatic abnormality | 0 | 1 | 0 | 1 |
| Overall Study | Other | 0 | 1 | 3 | 1 |
| Overall Study | Patient choice | 0 | 0 | 2 | 1 |
| Overall Study | Prostate-specific antigen increase >=25% | 0 | 1 | 5 | 3 |
| Overall Study | Protocol Violation | 0 | 1 | 3 | 0 |
| Overall Study | PSA decrease <=50% | 0 | 2 | 2 | 4 |
| Overall Study | PSA increase >= 10ng/mL | 0 | 1 | 1 | 0 |
| Overall Study | Testosterone 0.5 - 1.0 ng/mL | 1 | 0 | 3 | 2 |
| Overall Study | Testosterone >1.0 ng/mL | 9 | 9 | 5 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Degarelix 160 mg | Degarelix 120 mg | Degarelix 80 mg | Degarelix 40 mg |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 74 Participants | 20 Participants | 22 Participants | 23 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Age Continuous | 75.6 years STANDARD_DEVIATION 6.9 | 74.7 years STANDARD_DEVIATION 8.37 | 75.9 years STANDARD_DEVIATION 5.79 | 77.5 years STANDARD_DEVIATION 6.38 | 72.0 years STANDARD_DEVIATION 5.72 |
| Body mass index | 26.8 kilogram per square meter STANDARD_DEVIATION 3.64 | 26.6 kilogram per square meter STANDARD_DEVIATION 3.39 | 27.2 kilogram per square meter STANDARD_DEVIATION 3.15 | 26.6 kilogram per square meter STANDARD_DEVIATION 3.54 | 26.7 kilogram per square meter STANDARD_DEVIATION 5.66 |
| Gleason score 2-4 | 3 participants | 0 participants | 1 participants | 1 participants | 1 participants |
| Gleason score 5-6 | 42 participants | 13 participants | 12 participants | 14 participants | 3 participants |
| Gleason score 7-10 | 36 participants | 11 participants | 11 participants | 8 participants | 6 participants |
| Gleason score Unknown | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black | 6 participants | 1 participants | 2 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian | 63 participants | 20 participants | 15 participants | 23 participants | 5 participants |
| Race/Ethnicity, Customized Other | 13 participants | 3 participants | 7 participants | 0 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 82 Participants | 24 Participants | 24 Participants | 24 Participants | 10 Participants |
| Stage of prostate cancer Localized | 38 participants | 10 participants | 12 participants | 11 participants | 5 participants |
| Stage of prostate cancer Locally advanced | 16 participants | 5 participants | 5 participants | 6 participants | 0 participants |
| Stage of prostate cancer Metastatic | 10 participants | 2 participants | 2 participants | 4 participants | 2 participants |
| Stage of prostate cancer Not classifiable | 18 participants | 7 participants | 5 participants | 3 participants | 3 participants |
| Time since prostate cancer diagnosis | 1181 days STANDARD_DEVIATION 1494 | 1095 days STANDARD_DEVIATION 1385 | 1609 days STANDARD_DEVIATION 1836 | 954 days STANDARD_DEVIATION 1329 | 851 days STANDARD_DEVIATION 1077 |
| Weight | 81.0 kilogram STANDARD_DEVIATION 12.6 | 81.4 kilogram STANDARD_DEVIATION 14.4 | 80.8 kilogram STANDARD_DEVIATION 12.8 | 81.7 kilogram STANDARD_DEVIATION 11.5 | 79.0 kilogram STANDARD_DEVIATION 11.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / — | 19 / — | 21 / — | 16 / — |
| serious Total, serious adverse events | 0 / — | 5 / — | 7 / — | 2 / — |
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 CS06) and the extension study FE200486 CS06A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 40 mg | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 40 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 1 participants |
| Degarelix 40 mg | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 40 mg | Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 40 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 0 participants |
| Degarelix 80 mg | Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 80 mg | Liver Function Tests | ALAT >3x ULN | 1 participants |
| Degarelix 80 mg | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 80 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 13 participants |
| Degarelix 80 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 4 participants |
| Degarelix 120 mg | Liver Function Tests | Abnormal bilirubin | 4 participants |
| Degarelix 120 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 5 participants |
| Degarelix 120 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 18 participants |
| Degarelix 120 mg | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 120 mg | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 160 mg | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 160 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 9 participants |
| Degarelix 160 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 6 participants |
| Degarelix 160 mg | Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 160 mg | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 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 participants 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 CS06) and the extension study (FE200486 CS06A).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 40 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 0 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 1 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 3 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 1 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 2 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 6 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 2 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 1 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 3 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 1 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |