Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen ablation therapy
Brief summary
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).
Detailed description
Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL). The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.
Interventions
DRUGDegarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days 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
* Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant) * Had completed the FE200486 CS12 study Exclusion criterion: * Had been withdrawn from the FE200486 CS12 study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | 5 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. |
| Liver Function Tests | 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, Germany, Hungary, Netherlands, Romania, Russia, South Africa
Participant flow
Recruitment details
Participants who completed the main FE200486 CS12 study were asked to continue into the FE200486 CS12A extension study.
Pre-assignment details
189 participants were randomized into the main study CS12 and 147 patients completed CS12. Of these, 137 participants were recruited into the extension study CS12A and 109 participants signed the informed consent for dose shift.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 80 mg Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. | 45 |
| Degarelix 120 mg Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. | 48 |
| Degarelix 160 mg Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. | 44 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 15 | 16 | 15 |
| Overall Study | Difficult to attend visits | 0 | 1 | 0 |
| Overall Study | Intermittent therapy required | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 5 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | No study drug available | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 4 | 13 |
Baseline characteristics
| Characteristic | Degarelix 120 mg | Total | Degarelix 80 mg | Degarelix 160 mg |
|---|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 6.3 | 71.4 years STANDARD_DEVIATION 7.3 | 71.0 years STANDARD_DEVIATION 7.9 | 72.4 years STANDARD_DEVIATION 7.7 |
| Body Mass Index | 26.4 kilogram per square meter STANDARD_DEVIATION 3.4 | 26.2 kilogram per square meter STANDARD_DEVIATION 3.8 | 26.4 kilogram per square meter STANDARD_DEVIATION 4.5 | 25.7 kilogram per square meter STANDARD_DEVIATION 3.4 |
| Body Weight | 79.1 kilogram STANDARD_DEVIATION 13.2 | 78.4 kilogram STANDARD_DEVIATION 13.9 | 79.4 kilogram STANDARD_DEVIATION 15.9 | 76.8 kilogram STANDARD_DEVIATION 12.4 |
| Curative Intent No | 45 participants | 128 participants | 42 participants | 41 participants |
| Curative Intent Yes | 3 participants | 9 participants | 3 participants | 3 participants |
| Gleason Score 2-4 | 11 participants | 26 participants | 10 participants | 5 participants |
| Gleason Score 5-6 | 22 participants | 56 participants | 18 participants | 16 participants |
| Gleason Score 7-10 | 15 participants | 54 participants | 17 participants | 22 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants | 0 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 | 44 Participants | 133 Participants | 45 Participants | 44 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 48 Participants | 137 Participants | 45 Participants | 44 Participants |
| Stage of Prostate Cancer Localized | 14 participants | 32 participants | 10 participants | 8 participants |
| Stage of Prostate Cancer Locally advanced | 15 participants | 49 participants | 16 participants | 18 participants |
| Stage of Prostate Cancer Metastatic | 7 participants | 18 participants | 5 participants | 6 participants |
| Stage of Prostate Cancer Not classifiable | 12 participants | 38 participants | 14 participants | 12 participants |
| Time since Prostate Cancer Diagnosis | 227 days STANDARD_DEVIATION 590 | 343 days STANDARD_DEVIATION 798 | 355 days STANDARD_DEVIATION 645 | 457 days STANDARD_DEVIATION 1086 |
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 | 35 / 45 | 41 / 48 | 38 / 44 |
| serious Total, serious adverse events | 19 / 45 | 20 / 48 | 10 / 44 |
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: 5 years
Population: The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80 mg | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 3 participants |
| Degarelix 80 mg | Liver Function Tests | Abnormal bilirubin | 8 participants |
| Degarelix 80 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 19 participants |
| Degarelix 80 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 18 participants |
| Degarelix 80 mg | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 120 mg | Liver Function Tests | Abnormal bilirubin | 11 participants |
| Degarelix 120 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 18 participants |
| Degarelix 120 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 23 participants |
| Degarelix 120 mg | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 3 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, bilirubin >1.5x ULN | 0 participants |
| Degarelix 160 mg | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 3 participants |
| Degarelix 160 mg | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 23 participants |
| Degarelix 160 mg | Liver Function Tests | Abnormal bilirubin | 3 participants |
| Degarelix 160 mg | Liver Function Tests | Abnormal aspartate aminotransferase | 21 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: 5 years
Population: The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 3 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 9 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 1 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 4 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 3 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 4 participants |
| Degarelix 80 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 18 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 2 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 10 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 9 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 5 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 5 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 5 participants |
| Degarelix 120 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 19 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 2 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 9 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 10 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 8 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 8 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 5 participants |
| Degarelix 160 mg | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 14 participants |