NCT02003924 · OUTCOME
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
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
The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
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 | 887 |
|---|
| Placebo | 439 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | 119.5 | 17.75 | Not reported | Not reported | Not reported |
|---|
| Placebo | 120.8 | 16.73 | Not reported | Not reported | Not reported |
|---|
Change at Week 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 815 |
|---|
| Placebo | 403 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -4.0 | 14.03 | Not reported | Not reported | Not reported |
|---|
| Placebo | -3.0 | 13.87 | Not reported | Not reported | Not reported |
|---|
Change at Week 33
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 718 |
|---|
| Placebo | 329 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -4.6 | 14.82 | Not reported | Not reported | Not reported |
|---|
| Placebo | -3.5 | 13.74 | Not reported | Not reported | Not reported |
|---|
Change at Week 49
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 621 |
|---|
| Placebo | 239 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -3.9 | 14.70 | Not reported | Not reported | Not reported |
|---|
| Placebo | -5.0 | 15.71 | Not reported | Not reported | Not reported |
|---|
Change at Week 65
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 522 |
|---|
| Placebo | 183 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -4.0 | 15.84 | Not reported | Not reported | Not reported |
|---|
| Placebo | -5.7 | 15.04 | Not reported | Not reported | Not reported |
|---|
Change at Week 81
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 427 |
|---|
| Placebo | 139 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -4.1 | 15.01 | Not reported | Not reported | Not reported |
|---|
| Placebo | -7.5 | 16.42 | Not reported | Not reported | Not reported |
|---|
Change at Week 97
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 354 |
|---|
| Placebo | 90 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -4.9 | 15.31 | Not reported | Not reported | Not reported |
|---|
| Placebo | -5.9 | 15.80 | Not reported | Not reported | Not reported |
|---|
Change at Week 113
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 264 |
|---|
| Placebo | 68 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -5.5 | 16.07 | Not reported | Not reported | Not reported |
|---|
| Placebo | -5.8 | 13.16 | Not reported | Not reported | Not reported |
|---|
Change at Week 129
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 186 |
|---|
| Placebo | 37 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -6.3 | 17.33 | Not reported | Not reported | Not reported |
|---|
| Placebo | -8.1 | 13.99 | Not reported | Not reported | Not reported |
|---|
Change at Week 145
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 109 |
|---|
| Placebo | 17 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -5.5 | 18.75 | Not reported | Not reported | Not reported |
|---|
| Placebo | -9.8 | 15.47 | Not reported | Not reported | Not reported |
|---|
Change at Week 161
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 38 |
|---|
| Placebo | 6 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -8.9 | 19.88 | Not reported | Not reported | Not reported |
|---|
| Placebo | -7.0 | 10.95 | Not reported | Not reported | Not reported |
|---|
Change at Week 177
Analysis denominator · Participants
| Group | Source count |
|---|
| Enzalutamide 160 mg | 5 |
|---|
| Placebo | 1 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enzalutamide 160 mg | -4.8 | 13.19 | Not reported | Not reported | Not reported |
|---|
| Placebo | -5.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.75
- value
- 119.5
- group Id
- OG001
- spread
- 16.73
- value
- 120.8
- denoms
- counts
- group Id
- OG000
- value
- 887
- group Id
- OG001
- value
- 439
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 14.03
- value
- -4.0
- group Id
- OG001
- spread
- 13.87
- value
- -3.0
- denoms
- counts
- group Id
- OG000
- value
- 815
- group Id
- OG001
- value
- 403
- units
- Participants
- title
- Change at Week 17
- categories
- measurements
- group Id
- OG000
- spread
- 14.82
- value
- -4.6
- group Id
- OG001
- spread
- 13.74
- value
- -3.5
- denoms
- counts
- group Id
- OG000
- value
- 718
- group Id
- OG001
- value
- 329
- units
- Participants
- title
- Change at Week 33
- categories
- measurements
- group Id
- OG000
- spread
- 14.70
- value
- -3.9
- group Id
- OG001
- spread
- 15.71
- value
- -5.0
- denoms
- counts
- group Id
- OG000
- value
- 621
- group Id
- OG001
- value
- 239
- units
- Participants
- title
- Change at Week 49
- categories
- measurements
- group Id
- OG000
- spread
- 15.84
- value
- -4.0
- group Id
- OG001
- spread
- 15.04
- value
- -5.7
- denoms
- counts
- group Id
- OG000
- value
- 522
- group Id
- OG001
- value
- 183
- units
- Participants
- title
- Change at Week 65
- categories
- measurements
- group Id
- OG000
- spread
- 15.01
- value
- -4.1
- group Id
- OG001
- spread
- 16.42
- value
- -7.5
- denoms
- counts
- group Id
- OG000
- value
- 427
- group Id
- OG001
- value
- 139
- units
- Participants
- title
- Change at Week 81
- categories
- measurements
- group Id
- OG000
- spread
- 15.31
- value
- -4.9
- group Id
- OG001
- spread
- 15.80
- value
- -5.9
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 90
- units
- Participants
- title
- Change at Week 97
- categories
- measurements
- group Id
- OG000
- spread
- 16.07
- value
- -5.5
- group Id
- OG001
- spread
- 13.16
- value
- -5.8
- denoms
- counts
- group Id
- OG000
- value
- 264
- group Id
- OG001
- value
- 68
- units
- Participants
- title
- Change at Week 113
- categories
- measurements
- group Id
- OG000
- spread
- 17.33
- value
- -6.3
- group Id
- OG001
- spread
- 13.99
- value
- -8.1
- denoms
- counts
- group Id
- OG000
- value
- 186
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Change at Week 129
- categories
- measurements
- group Id
- OG000
- spread
- 18.75
- value
- -5.5
- group Id
- OG001
- spread
- 15.47
- value
- -9.8
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Change at Week 145
- categories
- measurements
- group Id
- OG000
- spread
- 19.88
- value
- -8.9
- group Id
- OG001
- spread
- 10.95
- value
- -7.0
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Change at Week 161
- categories
- measurements
- group Id
- OG000
- spread
- 13.19
- value
- -4.8
- group Id
- OG001
- value
- -5.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Change at Week 177
- denoms
- counts
- group Id
- OG000
- value
- 933
- group Id
- OG001
- value
- 468
- units
- Participants
- description
- The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
- 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
- Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
- 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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