Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen ablation therapy
Brief summary
This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.
Detailed description
Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants. The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.
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
* Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has completed study FE200486 CS14 through visit 22. Exclusion Criterion: * Has been withdrawn from the FE200486 CS14 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | 5 years | This outcome measure 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
Canada, United States
Participant flow
Recruitment details
Participants who completed the main FE200486 CS14 study were asked to continue into the FE200486 CS14A extension study.
Pre-assignment details
127 participants started and 87 participants completed the main CS14 study. Of these, 57 participants were recruited into the extension study CS14A and 34 participants signed the informed consent for dose shift.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix (60 mg to 160 mg) Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. | 30 |
| Degarelix (80 mg to 160 mg) Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. | 27 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 6 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 3 | 7 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Research site closing | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 2 |
Baseline characteristics
| Characteristic | Total | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) |
|---|---|---|---|
| Age, Continuous | 75.1 years STANDARD_DEVIATION 7.75 | 76.0 years STANDARD_DEVIATION 6.63 | 74.1 years STANDARD_DEVIATION 8.85 |
| Body mass index | 26.5 kilogram per square meter STANDARD_DEVIATION 4.1 | 26.5 kilogram per square meter STANDARD_DEVIATION 3.64 | 26.6 kilogram per square meter STANDARD_DEVIATION 4.63 |
| Body weight | 80.1 kilogram STANDARD_DEVIATION 12.2 | 79.0 kilogram STANDARD_DEVIATION 11.4 | 81.3 kilogram STANDARD_DEVIATION 13.3 |
| Curative Intent No | 35 participants | 19 participants | 16 participants |
| Curative Intent Yes | 22 participants | 11 participants | 11 participants |
| Gleason Score 2-4 | 3 participants | 2 participants | 1 participants |
| Gleason Score 5-6 | 13 participants | 5 participants | 8 participants |
| Gleason Score 7-10 | 41 participants | 23 participants | 18 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 24 Participants | 25 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 57 Participants | 30 Participants | 27 Participants |
| Stage of Prostate Cancer Localized | 21 participants | 14 participants | 7 participants |
| Stage of Prostate Cancer Locally advanced | 8 participants | 3 participants | 5 participants |
| Stage of Prostate Cancer Metastatic | 10 participants | 5 participants | 5 participants |
| Stage of Prostate Cancer Not classifiable | 18 participants | 8 participants | 10 participants |
| Time since Prostate Cancer Diagnosis | 1299 days STANDARD_DEVIATION 1580 | 1253 days STANDARD_DEVIATION 1565 | 1349 days STANDARD_DEVIATION 1625 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 30 | 26 / 27 |
| serious Total, serious adverse events | 11 / 30 | 7 / 27 |
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 CS14) and the extension study FE200486 CS14A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix (60 mg to 160 mg) | Liver Function Tests | Abnormal aspartate aminotransferase | 5 participants |
| Degarelix (60 mg to 160 mg) | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 0 participants |
| Degarelix (60 mg to 160 mg) | Liver Function Tests | Abnormal bilirubin | 7 participants |
| Degarelix (60 mg to 160 mg) | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix (60 mg to 160 mg) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 8 participants |
| Degarelix (80 mg to 160 mg) | Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix (80 mg to 160 mg) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 11 participants |
| Degarelix (80 mg to 160 mg) | Liver Function Tests | Abnormal aspartate aminotransferase | 4 participants |
| Degarelix (80 mg to 160 mg) | Liver Function Tests | Abnormal bilirubin | 5 participants |
| Degarelix (80 mg to 160 mg) | Liver Function Tests | ALAT >3x upper limit of normal (ULN) | 0 participants |
Primary
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
This outcome measure 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 CS14) and the extension study FE200486 CS14A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 9 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 3 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 3 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 5 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 2 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 6 participants |
| Degarelix (60 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 6 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 5 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 4 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 4 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 4 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 3 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 6 participants |
| Degarelix (80 mg to 160 mg) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 7 participants |