TriangleNCT01995513 · OUTCOME
Time to Prostate Specific Antigen (PSA) Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- 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
Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.
Analysis population: ITT population included all participants randomly assigned to study treatment.
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 | 126 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 125 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 2.8 | Not reported | 2.8 | 2.9 | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.8 | Not reported | 2.8 | 2.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.617
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.239
- estimate Comment
- Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.4500
- p Value Comment
- P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.874
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.617
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.239
- estimate Comment
- Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.4500
- p Value Comment
- P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.874
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 2.9
- value
- 2.8
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- 2.8
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 125
- units
- Participants
- description
- Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.
- 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
- MEDIAN
- population Description
- ITT population included all participants randomly assigned to study treatment.
- 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
- Time to Prostate Specific Antigen (PSA) Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice