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NCT01308580 · OUTCOME

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer · Source last updated 2017-04-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)

What was measured

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.

Analysis population: FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category.

Groups in this outcome

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cabazitaxel 20 mg/m^2521
Cabazitaxel 25 mg/m^2494

Reported measurements

Change from baseline at cycle 1 (n =521, 494)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^24.69Not reported2.956.44Not reported
Cabazitaxel 25 mg/m^25.08Not reported3.326.84Not reported
Change from baseline at cycle 2 (n = 500, 494)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^24.4Not reported2.676.14Not reported
Cabazitaxel 25 mg/m^25.55Not reported3.817.3Not reported
Change from baseline at cycle 3 (n =456, 451)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^23.75Not reported25.5Not reported
Cabazitaxel 25 mg/m^25.46Not reported3.77.23Not reported
Change from baseline at cycle 4 (n =420, 415)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^22.57Not reported0.84.33Not reported
Cabazitaxel 25 mg/m^23.82Not reported2.045.6Not reported
Change from baseline at cycle 5 (n =339, 361)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^21.78Not reported-0.033.59Not reported
Cabazitaxel 25 mg/m^23.06Not reported1.264.87Not reported
Change from baseline at cycle 6 (n =275, 318)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^22.57Not reported0.724.43Not reported
Cabazitaxel 25 mg/m^22.03Not reported0.23.86Not reported
Change from baseline at cycle 7 (n =225, 262)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^22.51Not reported0.64.42Not reported
Cabazitaxel 25 mg/m^22.73Not reported0.854.6Not reported
Change from baseline at cycle 8 (n =196, 227)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^21.44Not reported-0.53.39Not reported
Cabazitaxel 25 mg/m^22.08Not reported0.163.99Not reported
Change from baseline at cycle 9 (n =165, 172)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^20.94Not reported-1.062.94Not reported
Cabazitaxel 25 mg/m^21.46Not reported-0.553.46Not reported
Change from baseline at cycle 10 (n =137, 141)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^20.02Not reported-2.052.1Not reported
Cabazitaxel 25 mg/m^21.31Not reported-0.763.39Not reported
Change from baseline at Follow-up 1 (n =136, 152)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^2-2.27Not reported-4.35-0.19Not reported
Cabazitaxel 25 mg/m^2-1.16Not reported-3.210.88Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.95
        upper Limit
        6.44
        value
        4.69
      2. group Id
        OG001
        lower Limit
        3.32
        upper Limit
        6.84
        value
        5.08
    title
    Change from baseline at cycle 1 (n =521, 494)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.67
        upper Limit
        6.14
        value
        4.4
      2. group Id
        OG001
        lower Limit
        3.81
        upper Limit
        7.3
        value
        5.55
    title
    Change from baseline at cycle 2 (n = 500, 494)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        5.5
        value
        3.75
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        7.23
        value
        5.46
    title
    Change from baseline at cycle 3 (n =456, 451)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        4.33
        value
        2.57
      2. group Id
        OG001
        lower Limit
        2.04
        upper Limit
        5.6
        value
        3.82
    title
    Change from baseline at cycle 4 (n =420, 415)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.03
        upper Limit
        3.59
        value
        1.78
      2. group Id
        OG001
        lower Limit
        1.26
        upper Limit
        4.87
        value
        3.06
    title
    Change from baseline at cycle 5 (n =339, 361)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        4.43
        value
        2.57
      2. group Id
        OG001
        lower Limit
        0.2
        upper Limit
        3.86
        value
        2.03
    title
    Change from baseline at cycle 6 (n =275, 318)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        4.42
        value
        2.51
      2. group Id
        OG001
        lower Limit
        0.85
        upper Limit
        4.6
        value
        2.73
    title
    Change from baseline at cycle 7 (n =225, 262)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.5
        upper Limit
        3.39
        value
        1.44
      2. group Id
        OG001
        lower Limit
        0.16
        upper Limit
        3.99
        value
        2.08
    title
    Change from baseline at cycle 8 (n =196, 227)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.06
        upper Limit
        2.94
        value
        0.94
      2. group Id
        OG001
        lower Limit
        -0.55
        upper Limit
        3.46
        value
        1.46
    title
    Change from baseline at cycle 9 (n =165, 172)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.05
        upper Limit
        2.1
        value
        0.02
      2. group Id
        OG001
        lower Limit
        -0.76
        upper Limit
        3.39
        value
        1.31
    title
    Change from baseline at cycle 10 (n =137, 141)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.35
        upper Limit
        -0.19
        value
        -2.27
      2. group Id
        OG001
        lower Limit
        -3.21
        upper Limit
        0.88
        value
        -1.16
    title
    Change from baseline at Follow-up 1 (n =136, 152)
denoms
  1. counts
    1. group Id
      OG000
      value
      521
    2. group Id
      OG001
      value
      494
    units
    Participants
description
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG000
    title
    Cabazitaxel 20 mg/m^2
  2. description
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG001
    title
    Cabazitaxel 25 mg/m^2
param Type
LEAST_SQUARES_MEAN
population Description
FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category.
reporting Status
POSTED
time Frame
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
title
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice