TriangleNCT00451958 · OUTCOME
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
What was measured
PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
Analysis population: CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).
Groups in this outcome
Degarelix 80 mg / Degarelix 80 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
Degarelix 160 mg / Degarelix 160 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 80 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 160 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
| Group | Source count |
|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 207 |
| Degarelix 160 mg / Degarelix 160 mg | 202 |
| Leuprolide 7.5 mg / Degarelix 80 mg | 69 |
| Leuprolide 7.5 mg / Degarelix 160 mg | 132 |
Reported measurements
Day 28
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 100 | Not reported | 100 | 100 | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 99.5 | Not reported | 96.5 | 99.9 | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 98.6 | Not reported | 90.2 | 99.8 | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 100 | Not reported | 100 | 100 | Not reported |
Day 364
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 91.1 | Not reported | 85.9 | 94.5 | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 85.8 | Not reported | 79.8 | 90.1 | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 82.6 | Not reported | 71.4 | 89.7 | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 87.9 | Not reported | 80.4 | 92.7 | Not reported |
Day 1960
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 61.0 | Not reported | 50.9 | 69.7 | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 58.7 | Not reported | 48.7 | 67.4 | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 50.7 | Not reported | 36.3 | 63.4 | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 73.8 | Not reported | 60.9 | 83.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 100
- upper Limit
- 100
- value
- 100
- group Id
- OG001
- lower Limit
- 96.5
- upper Limit
- 99.9
- value
- 99.5
- group Id
- OG002
- lower Limit
- 90.2
- upper Limit
- 99.8
- value
- 98.6
- group Id
- OG003
- lower Limit
- 100
- upper Limit
- 100
- value
- 100
- title
- Day 28
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.9
- upper Limit
- 94.5
- value
- 91.1
- group Id
- OG001
- lower Limit
- 79.8
- upper Limit
- 90.1
- value
- 85.8
- group Id
- OG002
- lower Limit
- 71.4
- upper Limit
- 89.7
- value
- 82.6
- group Id
- OG003
- lower Limit
- 80.4
- upper Limit
- 92.7
- value
- 87.9
- title
- Day 364
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.9
- upper Limit
- 69.7
- value
- 61.0
- group Id
- OG001
- lower Limit
- 48.7
- upper Limit
- 67.4
- value
- 58.7
- group Id
- OG002
- lower Limit
- 36.3
- upper Limit
- 63.4
- value
- 50.7
- group Id
- OG003
- lower Limit
- 60.9
- upper Limit
- 83.0
- value
- 73.8
- title
- Day 1960
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 202
- group Id
- OG002
- value
- 69
- group Id
- OG003
- value
- 132
- units
- Participants
- description
- PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
- id
- OG000
- title
- Degarelix 80 mg / Degarelix 80 mg
- description
- The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG001
- title
- Degarelix 160 mg / Degarelix 160 mg
- description
- During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG002
- title
- Leuprolide 7.5 mg / Degarelix 80 mg
- description
- During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG003
- title
- Leuprolide 7.5 mg / Degarelix 160 mg
- param Type
- NUMBER
- population Description
- CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).
- reporting Status
- POSTED
- time Frame
- Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
- title
- Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice