TriangleNCT01995513 · OUTCOME
Prostate Specific Antigen (PSA) Response Rate
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 disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
What was measured
PSA response rate was defined as percentage of participants with \>=30% and \>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.
Analysis population: Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure.
Groups in this outcome
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
| Group | Source count |
|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 124 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 122 |
Reported measurements
>= 50%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 0.8 | Not reported | 0.0 | 4.4 | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.5 | Not reported | 0.5 | 7.0 | Not reported |
>= 30%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 2.4 | Not reported | 0.5 | 6.9 | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.5 | Not reported | 0.5 | 7.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.51
- estimate Comment
- Difference in response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with \>=50% decrease from baseline in PSA response.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3101
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Response Rate
- param Value
- -1.65
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -3.90
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.82
- estimate Comment
- Difference in response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with \>=30% decrease from baseline in PSA response.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.9917
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Response Rate
- param Value
- -0.04
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -4.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.51
- estimate Comment
- Difference in response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with \>=50% decrease from baseline in PSA response.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3101
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Response Rate
- param Value
- -1.65
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -3.90
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.82
- estimate Comment
- Difference in response rate was based upon standard normal approximation.
- group Description
- This analysis is reported for participants with \>=30% decrease from baseline in PSA response.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.9917
- p Value Comment
- P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Difference in Response Rate
- param Value
- -0.04
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 4.4
- value
- 0.8
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 7.0
- value
- 2.5
- title
- >= 50%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 6.9
- value
- 2.4
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 7.0
- value
- 2.5
- title
- >= 30%
- denoms
- counts
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 122
- units
- Participants
- description
- PSA response rate was defined as percentage of participants with \>=30% and \>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
- id
- OG000
- title
- Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
- description
- Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
- id
- OG001
- title
- Placebo+Abiraterone 1000mg+ Prednisone 10mg
- param Type
- NUMBER
- population Description
- Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
- title
- Prostate Specific Antigen (PSA) Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice