TriangleNCT02003924 · OUTCOME
Percentage of Participants With Prostate Specific Antigen (PSA) Response
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
- From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
What was measured
PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
Analysis population: The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Overall number of participants analyzed' = participants with baseline and at least one post-baseline PSA assessment.
Groups in this outcome
Enzalutamide 160 mg
Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
Placebo
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
| Group | Source count |
|---|---|
| Enzalutamide 160 mg | 933 |
| Placebo | 468 |
Reported measurements
Decrease from Baseline >= 50%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160 mg | 76.3 | Not reported | 73.5 | 79.0 | Not reported |
| Placebo | 2.4 | Not reported | 1.2 | 4.2 | Not reported |
Decrease from Baseline >= 90%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160 mg | 55.9 | Not reported | 52.7 | 59.2 | Not reported |
| Placebo | 0.4 | Not reported | 0.1 | 1.5 | Not reported |
Decrease to Undetectable Level
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160 mg | 9.6 | Not reported | 7.8 | 11.7 | Not reported |
| Placebo | 0 | Not reported | 0 | 0.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 70.91
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 77.02
- group Description
- Decrease from Baseline \>= 50%
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
- param Type
- Difference in Response Rate
- param Value
- 73.96
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 52.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 58.76
- group Description
- Decrease from Baseline \>= 90%
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS
- param Type
- Difference in Response Rate
- param Value
- 55.52
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 7.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.54
- group Description
- Decrease to Undetectable Level
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
- param Type
- Difference in Response Rate
- param Value
- 9.65
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 70.91
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 77.02
- group Description
- Decrease from Baseline \>= 50%
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
- param Type
- Difference in Response Rate
- param Value
- 73.96
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 52.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 58.76
- group Description
- Decrease from Baseline \>= 90%
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS
- param Type
- Difference in Response Rate
- param Value
- 55.52
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 7.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.54
- group Description
- Decrease to Undetectable Level
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
- param Type
- Difference in Response Rate
- param Value
- 9.65
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.5
- upper Limit
- 79.0
- value
- 76.3
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 4.2
- value
- 2.4
- title
- Decrease from Baseline >= 50%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.7
- upper Limit
- 59.2
- value
- 55.9
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 1.5
- value
- 0.4
- title
- Decrease from Baseline >= 90%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.8
- upper Limit
- 11.7
- value
- 9.6
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0.8
- value
- 0
- title
- Decrease to Undetectable Level
- denoms
- counts
- group Id
- OG000
- value
- 933
- group Id
- OG001
- value
- 468
- units
- Participants
- description
- PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
- id
- OG000
- title
- Enzalutamide 160 mg
- description
- Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Overall number of participants analyzed' = participants with baseline and at least one post-baseline PSA assessment.
- reporting Status
- POSTED
- time Frame
- From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
- title
- Percentage of Participants With Prostate Specific Antigen (PSA) Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice