Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen ablation therapy
Brief summary
The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.
Detailed description
The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.
Interventions
DRUGDegarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NON_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 given written consent prior to 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 successfully completed the main study. Exclusion Criterion: \- Has been withdrawn from the main study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Baseline and up to 4.5 years | This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value. |
| Liver Function Tests | 4.5 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. |
Countries
Belgium, Finland, France, Germany, Montenegro, Netherlands, Romania, Russia, Serbia, United Kingdom
Participant flow
Recruitment details
Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.
Pre-assignment details
447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 240/240@40(1-3-6-9) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). | 90 |
| Degarelix 240/240@60(1-3-6-9) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). | 95 |
| Degarelix 240/240@60(1-4-7-10) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). | 93 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 17 | 20 |
| Overall Study | Disease Progression | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 3 | 0 |
| Overall Study | Lost to Follow-up | 5 | 2 | 4 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Trial Site Closed | 4 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 14 | 15 | 13 |
Baseline characteristics
| Characteristic | Degarelix 240/240@60(1-3-6-9) | Total | Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) |
|---|---|---|---|---|
| Age Continuous | 73.3 years STANDARD_DEVIATION 7 | 72.6 years STANDARD_DEVIATION 6.88 | 72.7 years STANDARD_DEVIATION 6.55 | 71.8 years STANDARD_DEVIATION 7.05 |
| Body Mass Index | 25.8 kilogram per square meter STANDARD_DEVIATION 3.93 | 25.7 kilogram per square meter STANDARD_DEVIATION 4.07 | 25.4 kilogram per square meter STANDARD_DEVIATION 4.14 | 25.8 kilogram per square meter STANDARD_DEVIATION 4.16 |
| Body Weight | 76.9 kilogram STANDARD_DEVIATION 12.2 | 76.7 kilogram STANDARD_DEVIATION 12.6 | 76.7 kilogram STANDARD_DEVIATION 13 | 76.5 kilogram STANDARD_DEVIATION 12.8 |
| Curative Intent No | 83 participants | 249 participants | 80 participants | 86 participants |
| Curative Intent Yes | 12 participants | 29 participants | 10 participants | 7 participants |
| Gleason Score 2-4 | 6 participants | 32 participants | 13 participants | 13 participants |
| Gleason Score 5-6 | 30 participants | 97 participants | 33 participants | 34 participants |
| Gleason Score 7-10 | 58 participants | 148 participants | 44 participants | 46 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 89 Participants | 264 Participants | 87 Participants | 88 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 95 Participants | 278 Participants | 90 Participants | 93 Participants |
| Stage of Prostate Cancer Localized | 37 participants | 107 participants | 34 participants | 36 participants |
| Stage of Prostate Cancer Locally Advanced | 26 participants | 80 participants | 26 participants | 28 participants |
| Stage of Prostate Cancer Metastatic | 19 participants | 55 participants | 16 participants | 20 participants |
| Stage of Prostate Cancer Not Classifiable | 13 participants | 36 participants | 14 participants | 9 participants |
| Time since Prostate Cancer Diagnosis | 347 days STANDARD_DEVIATION 824 | 356 days STANDARD_DEVIATION 852 | 469 days STANDARD_DEVIATION 1079 | 255 days STANDARD_DEVIATION 583 |
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 | 72 / 90 | 75 / 95 | 69 / 93 |
| serious Total, serious adverse events | 30 / 90 | 24 / 95 | 21 / 93 |
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: 4.5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/240@40(1-3-6-9) | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 3 participants |
| Degarelix 240/240@40(1-3-6-9) | Liver Function Tests | Abnormal bilirubin | 4 participants |
| Degarelix 240/240@40(1-3-6-9) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 22 participants |
| Degarelix 240/240@40(1-3-6-9) | Liver Function Tests | Abnormal aspartate aminotransferase | 18 participants |
| Degarelix 240/240@40(1-3-6-9) | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 240/240@60(1-3-6-9) | Liver Function Tests | Abnormal bilirubin | 5 participants |
| Degarelix 240/240@60(1-3-6-9) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 22 participants |
| Degarelix 240/240@60(1-3-6-9) | Liver Function Tests | Abnormal aspartate aminotransferase | 25 participants |
| Degarelix 240/240@60(1-3-6-9) | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 2 participants |
| Degarelix 240/240@60(1-3-6-9) | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 240/240@60(1-4-7-10) | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 240/240@60(1-4-7-10) | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 3 participants |
| Degarelix 240/240@60(1-4-7-10) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 17 participants |
| Degarelix 240/240@60(1-4-7-10) | Liver Function Tests | Abnormal bilirubin | 3 participants |
| Degarelix 240/240@60(1-4-7-10) | Liver Function Tests | Abnormal aspartate aminotransferase | 19 participants |
Primary
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.
Time frame: Baseline and up to 4.5 years
Population: The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 1 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 5 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 8 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 32 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 7 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 9 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 7 participants |
| Degarelix 240/240@40(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 6 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 4 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 6 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 8 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 35 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 1 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 11 participants |
| Degarelix 240/240@60(1-3-6-9) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 10 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 41 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 4 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 8 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 2 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 10 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 5 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 240/240@60(1-4-7-10) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 4 participants |