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NCT01995513 · OUTCOME

Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients · Source last updated 2023-09-18

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, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

What was measured

The FACT-P 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 for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.

Analysis population: ITT population included all participants randomly assigned to study treatment.

Groups in this outcome

Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg

Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.

Placebo+Abiraterone 1000mg+ Prednisone 10mg

Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.

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 160mg+Abiraterone 1000mg+ Prednisone 10mg	126
Placebo+Abiraterone 1000mg+ Prednisone 10mg	125

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	125
Placebo+Abiraterone 1000mg+ Prednisone 10mg	123

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	22.1	5.80	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	22.4	4.84	Not reported	Not reported	Not reported

Change at Week 9

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	104
Placebo+Abiraterone 1000mg+ Prednisone 10mg	108

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.5	4.33	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.8	4.13	Not reported	Not reported	Not reported

Change at Week 13

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	89
Placebo+Abiraterone 1000mg+ Prednisone 10mg	89

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.4	3.46	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.4	3.86	Not reported	Not reported	Not reported

Change at Week 17

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	84
Placebo+Abiraterone 1000mg+ Prednisone 10mg	80

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.1	3.68	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.6	4.64	Not reported	Not reported	Not reported

Change at Week 21

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	70
Placebo+Abiraterone 1000mg+ Prednisone 10mg	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.5	3.24	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-1.2	5.75	Not reported	Not reported	Not reported

Change at Week 25

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	62
Placebo+Abiraterone 1000mg+ Prednisone 10mg	62

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	0.1	2.79	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-1.0	5.25	Not reported	Not reported	Not reported

Change at Week 29

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	51
Placebo+Abiraterone 1000mg+ Prednisone 10mg	50

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.1	3.20	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.2	5.18	Not reported	Not reported	Not reported

Change at Week 33

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	44
Placebo+Abiraterone 1000mg+ Prednisone 10mg	44

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.2	3.21	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0.0	4.95	Not reported	Not reported	Not reported

Change at Week 37

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	36
Placebo+Abiraterone 1000mg+ Prednisone 10mg	33

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.8	3.04	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0.8	2.79	Not reported	Not reported	Not reported

Change at Week 41

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	31
Placebo+Abiraterone 1000mg+ Prednisone 10mg	29

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-1.4	3.75	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.1	3.51	Not reported	Not reported	Not reported

Change at Week 45

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	28
Placebo+Abiraterone 1000mg+ Prednisone 10mg	27

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.9	3.36	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.8	3.75	Not reported	Not reported	Not reported

Change at Week 49

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	27
Placebo+Abiraterone 1000mg+ Prednisone 10mg	18

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.6	2.88	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0.0	2.65	Not reported	Not reported	Not reported

Change at Week 53

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	21
Placebo+Abiraterone 1000mg+ Prednisone 10mg	15

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-1.0	3.15	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0.4	2.56	Not reported	Not reported	Not reported

Change at Week 57

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	17
Placebo+Abiraterone 1000mg+ Prednisone 10mg	13

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-2.0	3.06	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0.2	1.29	Not reported	Not reported	Not reported

Change at Week 61

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	13
Placebo+Abiraterone 1000mg+ Prednisone 10mg	10

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-1.5	2.77	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.2	1.80	Not reported	Not reported	Not reported

Change at Week 65

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	13
Placebo+Abiraterone 1000mg+ Prednisone 10mg	7

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-1.5	2.54	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.5	0.96	Not reported	Not reported	Not reported

Change at Week 69

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	10
Placebo+Abiraterone 1000mg+ Prednisone 10mg	7

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-1.4	2.03	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.5	0.96	Not reported	Not reported	Not reported

Change at Week 73

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	8
Placebo+Abiraterone 1000mg+ Prednisone 10mg	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.6	3.22	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-1.0	NA	Not reported	Not reported	As only 1 participant was analyzed at Week 73, standard deviation could not be calculated.

Change at Week 77

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	7
Placebo+Abiraterone 1000mg+ Prednisone 10mg	2

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-0.9	3.41	Not reported	Not reported	Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg	-0.5	0.71	Not reported	Not reported	Not reported

Change at Week 81

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	2
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	6.2	5.42	Not reported	Not reported	Not reported

Change at Week 85

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	2
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	-1.0	1.41	Not reported	Not reported	Not reported

Change at Week 89

Analysis denominator · Participants

Group	Source count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	1
Placebo+Abiraterone 1000mg+ Prednisone 10mg	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg	0.0	NA	Not reported	Not reported	As only 1 participant was analyzed at Week 89, standard deviation could not be calculated.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5.80
value
22.1
group Id
OG001
spread
4.84
value
22.4
denoms
counts
group Id
OG000
value
125
group Id
OG001
value
123
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
4.33
value
-0.5
group Id
OG001
spread
4.13
value
-0.8
denoms
counts
group Id
OG000
value
104
group Id
OG001
value
108
units
Participants
title
Change at Week 9
categories
measurements
group Id
OG000
spread
3.46
value
-0.4
group Id
OG001
spread
3.86
value
-0.4
denoms
counts
group Id
OG000
value
89
group Id
OG001
value
89
units
Participants
title
Change at Week 13
categories
measurements
group Id
OG000
spread
3.68
value
-0.1
group Id
OG001
spread
4.64
value
-0.6
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
80
units
Participants
title
Change at Week 17
categories
measurements
group Id
OG000
spread
3.24
value
-0.5
group Id
OG001
spread
5.75
value
-1.2
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
67
units
Participants
title
Change at Week 21
categories
measurements
group Id
OG000
spread
2.79
value
0.1
group Id
OG001
spread
5.25
value
-1.0
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
62
units
Participants
title
Change at Week 25
categories
measurements
group Id
OG000
spread
3.20
value
-0.1
group Id
OG001
spread
5.18
value
-0.2
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
50
units
Participants
title
Change at Week 29
categories
measurements
group Id
OG000
spread
3.21
value
-0.2
group Id
OG001
spread
4.95
value
0.0
denoms
counts
group Id
OG000
value
44
group Id
OG001
value
44
units
Participants
title
Change at Week 33
categories
measurements
group Id
OG000
spread
3.04
value
-0.8
group Id
OG001
spread
2.79
value
0.8
denoms
counts
group Id
OG000
value
36
group Id
OG001
value
33
units
Participants
title
Change at Week 37
categories
measurements
group Id
OG000
spread
3.75
value
-1.4
group Id
OG001
spread
3.51
value
-0.1
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
29
units
Participants
title
Change at Week 41
categories
measurements
group Id
OG000
spread
3.36
value
-0.9
group Id
OG001
spread
3.75
value
-0.8
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
27
units
Participants
title
Change at Week 45
categories
measurements
group Id
OG000
spread
2.88
value
-0.6
group Id
OG001
spread
2.65
value
0.0
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
18
units
Participants
title
Change at Week 49

denoms

counts
group Id
OG000
value
126
group Id
OG001
value
125
units
Participants

description

The FACT-P 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 for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.

dispersion Type

Standard Deviation

groups

description
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
id
OG000
title
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
description
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
id
OG001
title
Placebo+Abiraterone 1000mg+ Prednisone 10mg

param Type

MEAN

population Description

ITT population included all participants randomly assigned to study treatment.

reporting Status

POSTED

time Frame

Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

title

Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores

type

SECONDARY

unit Of Measure

units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice