TriangleNCT01995513 · OUTCOME
Progression Free Survival (PFS)
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 or death due to any cause, whichever occurred first (maximum up to 20.3 months)
What was measured
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor 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 | 5.7 | Not reported | 4.6 | 8.1 | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 5.6 | Not reported | 4.5 | 7.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.612
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.119
- 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
- 0.2176
- p Value Comment
- P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.828
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.612
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.119
- 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
- 0.2176
- p Value Comment
- P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.828
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 8.1
- value
- 5.7
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 7.3
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 125
- units
- Participants
- description
- PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor 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 or death due to any cause, whichever occurred first (maximum up to 20.3 months)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice