TriangleNCT02677896 · OUTCOME
rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria
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 the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)
What was measured
rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
Analysis population: ITT
Groups in this outcome
Enzalutamide + Androgen Deprivation Therapy (ADT)
Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Placebo + Androgen Deprivation Therapy (ADT)
Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
| Group | Source count |
|---|---|
| Enzalutamide + Androgen Deprivation Therapy (ADT) | 574 |
| Placebo + Androgen Deprivation Therapy (ADT) | 576 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide + Androgen Deprivation Therapy (ADT) | NA | Not reported | NA | NA | Not reached. Data was not reached due to low number of events. |
| Placebo + Androgen Deprivation Therapy (ADT) | 19.0 | Not reported | 16.59 | 22.24 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.30
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.50
- group Description
- rPFS Treatment Comparision
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Cox proportional hazards model
- param Value
- 0.39
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.30
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.50
- group Description
- rPFS Treatment Comparision
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Cox proportional hazards model
- param Value
- 0.39
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Not reached. Data was not reached due to low number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 16.59
- upper Limit
- 22.24
- value
- 19.0
- denoms
- counts
- group Id
- OG000
- value
- 574
- group Id
- OG001
- value
- 576
- units
- Participants
- description
- rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- id
- OG000
- title
- Enzalutamide + Androgen Deprivation Therapy (ADT)
- description
- Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
- id
- OG001
- title
- Placebo + Androgen Deprivation Therapy (ADT)
- param Type
- MEDIAN
- population Description
- ITT
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)
- title
- rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice