TriangleNCT01664923 · 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 the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
What was measured
PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.
Analysis population: Intent-to-treat population: all participants randomly assigned to study treatment.
Groups in this outcome
Enzalutamide
Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
Bicalutamide
Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
| Group | Source count |
|---|---|
| Enzalutamide | 198 |
| Bicalutamide | 198 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 19.4 | Not reported | 16.5 | NA | The upper limit of the 95% confidence interval was not available because an insufficient number of participants had an event at the time of analysis. |
| Bicalutamide | 5.7 | Not reported | 5.6 | 8.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.181
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.320
- estimate Comment
- Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.240
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.181
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.320
- estimate Comment
- Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.240
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The upper limit of the 95% confidence interval was not available because an insufficient number of participants had an event at the time of analysis.
- group Id
- OG000
- lower Limit
- 16.5
- upper Limit
- NA
- value
- 19.4
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 8.1
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 198
- units
- Participants
- description
- PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
- id
- OG001
- title
- Bicalutamide
- param Type
- MEDIAN
- population Description
- Intent-to-treat population: all participants randomly assigned to study treatment.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
- 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