NCT02003924 · OUTCOME
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer · Source last updated 2026-01-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
What was measured
EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
Analysis population: The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified timepoints.
Groups in this outcome
Enzalutamide 160 mg
Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
Placebo
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 933 |
|---|
| Placebo | 468 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 884 |
|---|
| Placebo | 439 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 76.2 | 16.92 | Not reported | Not reported | Not reported |
|---|
| Placebo | 77.5 | 15.97 | Not reported | Not reported | Not reported |
|---|
Week 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 840 |
|---|
| Placebo | 419 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.7 | 17.19 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.9 | 16.79 | Not reported | Not reported | Not reported |
|---|
Week 33
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 738 |
|---|
| Placebo | 342 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.6 | 16.69 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.0 | 17.51 | Not reported | Not reported | Not reported |
|---|
Week 49
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 635 |
|---|
| Placebo | 250 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.7 | 18.02 | Not reported | Not reported | Not reported |
|---|
| Placebo | 73.7 | 18.28 | Not reported | Not reported | Not reported |
|---|
Week 65
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 536 |
|---|
| Placebo | 193 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.5 | 17.79 | Not reported | Not reported | Not reported |
|---|
| Placebo | 73.0 | 17.11 | Not reported | Not reported | Not reported |
|---|
Week 81
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 435 |
|---|
| Placebo | 148 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 75.5 | 17.06 | Not reported | Not reported | Not reported |
|---|
| Placebo | 73.3 | 16.82 | Not reported | Not reported | Not reported |
|---|
Week 97
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 365 |
|---|
| Placebo | 95 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.4 | 17.39 | Not reported | Not reported | Not reported |
|---|
| Placebo | 75.2 | 17.88 | Not reported | Not reported | Not reported |
|---|
Week 113
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 275 |
|---|
| Placebo | 73 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 73.6 | 18.05 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.7 | 15.06 | Not reported | Not reported | Not reported |
|---|
Week 129
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 193 |
|---|
| Placebo | 41 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 72.8 | 18.25 | Not reported | Not reported | Not reported |
|---|
| Placebo | 77.1 | 12.83 | Not reported | Not reported | Not reported |
|---|
Week 145
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 116 |
|---|
| Placebo | 21 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 75.3 | 17.02 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.2 | 18.13 | Not reported | Not reported | Not reported |
|---|
Week 161
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 40 |
|---|
| Placebo | 8 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.6 | 21.28 | Not reported | Not reported | Not reported |
|---|
| Placebo | 73.8 | 17.60 | Not reported | Not reported | Not reported |
|---|
Week 177
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 6 |
|---|
| Placebo | 1 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 74.5 | 19.31 | Not reported | Not reported | Not reported |
|---|
| Placebo | 69.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.92
- value
- 76.2
- group Id
- OG001
- spread
- 15.97
- value
- 77.5
- denoms
- counts
- group Id
- OG000
- value
- 884
- group Id
- OG001
- value
- 439
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 17.19
- value
- 74.7
- group Id
- OG001
- spread
- 16.79
- value
- 74.9
- denoms
- counts
- group Id
- OG000
- value
- 840
- group Id
- OG001
- value
- 419
- units
- Participants
- title
- Week 17
- categories
- measurements
- group Id
- OG000
- spread
- 16.69
- value
- 74.6
- group Id
- OG001
- spread
- 17.51
- value
- 74.0
- denoms
- counts
- group Id
- OG000
- value
- 738
- group Id
- OG001
- value
- 342
- units
- Participants
- title
- Week 33
- categories
- measurements
- group Id
- OG000
- spread
- 18.02
- value
- 74.7
- group Id
- OG001
- spread
- 18.28
- value
- 73.7
- denoms
- counts
- group Id
- OG000
- value
- 635
- group Id
- OG001
- value
- 250
- units
- Participants
- title
- Week 49
- categories
- measurements
- group Id
- OG000
- spread
- 17.79
- value
- 74.5
- group Id
- OG001
- spread
- 17.11
- value
- 73.0
- denoms
- counts
- group Id
- OG000
- value
- 536
- group Id
- OG001
- value
- 193
- units
- Participants
- title
- Week 65
- categories
- measurements
- group Id
- OG000
- spread
- 17.06
- value
- 75.5
- group Id
- OG001
- spread
- 16.82
- value
- 73.3
- denoms
- counts
- group Id
- OG000
- value
- 435
- group Id
- OG001
- value
- 148
- units
- Participants
- title
- Week 81
- categories
- measurements
- group Id
- OG000
- spread
- 17.39
- value
- 74.4
- group Id
- OG001
- spread
- 17.88
- value
- 75.2
- denoms
- counts
- group Id
- OG000
- value
- 365
- group Id
- OG001
- value
- 95
- units
- Participants
- title
- Week 97
- categories
- measurements
- group Id
- OG000
- spread
- 18.05
- value
- 73.6
- group Id
- OG001
- spread
- 15.06
- value
- 74.7
- denoms
- counts
- group Id
- OG000
- value
- 275
- group Id
- OG001
- value
- 73
- units
- Participants
- title
- Week 113
- categories
- measurements
- group Id
- OG000
- spread
- 18.25
- value
- 72.8
- group Id
- OG001
- spread
- 12.83
- value
- 77.1
- denoms
- counts
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 41
- units
- Participants
- title
- Week 129
- categories
- measurements
- group Id
- OG000
- spread
- 17.02
- value
- 75.3
- group Id
- OG001
- spread
- 18.13
- value
- 74.2
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Week 145
- categories
- measurements
- group Id
- OG000
- spread
- 21.28
- value
- 74.6
- group Id
- OG001
- spread
- 17.60
- value
- 73.8
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Week 161
- categories
- measurements
- group Id
- OG000
- spread
- 19.31
- value
- 74.5
- group Id
- OG001
- value
- 69.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Week 177
- denoms
- counts
- group Id
- OG000
- value
- 933
- group Id
- OG001
- value
- 468
- units
- Participants
- description
- EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
- id
- OG000
- title
- Enzalutamide 160 mg
- description
- Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified timepoints.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
- title
- European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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