TriangleNCT02677896 · 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 the date of randomization to the first observation of PSA progression (maximum duration was 26.6 months)
What was measured
Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).
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) | NA | Not reported | 16.59 | NA | Not reached. Data was not reached due to low number of events. |
Source statistical analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.26
- estimate Comment
- Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
- group Description
- Time to PSA Progression Treatment Comparison
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
- param Type
- Cox hazard ratio
- param Value
- 0.19
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.26
- estimate Comment
- Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
- group Description
- Time to PSA Progression Treatment Comparison
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
- param Type
- Cox hazard ratio
- param Value
- 0.19
- 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
- comment
- Not reached. Data was not reached due to low number of events.
- group Id
- OG001
- lower Limit
- 16.59
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 574
- group Id
- OG001
- value
- 576
- units
- Participants
- description
- Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).
- 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 observation of PSA progression (maximum duration was 26.6 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