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NCT01995513 · OUTCOME

Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to maximum of 18.4 months

What was measured

Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. 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, and 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, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.

Analysis population: Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.

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

GroupSource count
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg126
Placebo+Abiraterone 1000mg+ Prednisone 10mg125

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg4.6Not reported3.76.5Not reported
Placebo+Abiraterone 1000mg+ Prednisone 10mg6.4Not reported5.513.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.967
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.025
    estimate Comment
    Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0739
    p Value Comment
    P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period
    param Type
    Hazard Ratio (HR)
    param Value
    1.399
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.967
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.025
    estimate Comment
    Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0739
    p Value Comment
    P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period
    param Type
    Hazard Ratio (HR)
    param Value
    1.399
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.7
        upper Limit
        6.5
        value
        4.6
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        13.9
        value
        6.4
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    2. group Id
      OG001
      value
      125
    units
    Participants
description
Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. 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, and 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, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
MEDIAN
population Description
Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.
reporting Status
POSTED
time Frame
From randomization up to maximum of 18.4 months
title
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice