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NCT02485691 · OUTCOME

Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent · Source last updated 2022-05-27

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to 141 weeks)

What was measured

Health-related quality of life (HRQOL) evaluation was performed using the FACT-P questionnaire (Version 4). FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted 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 total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms. Baseline corresponded to last evaluable assessment before treatment administration.

Analysis population: Analysis was performed on HRQOL population which included participants who received at least one dose of the study drug and with an evaluable FACT-P questionnaire at baseline and at least one post-baseline evaluable FACT-P. Here 'Number analyzed' signifies participants with available data for each specified category.

Groups in this outcome

Cabazitaxel

Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).

Abiraterone Acetate or Enzalutamide

Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).

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

Analysis denominator · Participants

GroupSource count
Cabazitaxel108
Abiraterone Acetate or Enzalutamide114

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Cabazitaxel104
Abiraterone Acetate or Enzalutamide106
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel2.612.3Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide-0.012.4Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Cabazitaxel99
Abiraterone Acetate or Enzalutamide94
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel2.716.1Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide-1.016.8Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Cabazitaxel93
Abiraterone Acetate or Enzalutamide77
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel2.814.8Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide-0.716.8Not reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
Cabazitaxel79
Abiraterone Acetate or Enzalutamide56
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel2.117.9Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide-1.016.1Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Cabazitaxel64
Abiraterone Acetate or Enzalutamide39
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel-3.718.0Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide0.418.6Not reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Cabazitaxel58
Abiraterone Acetate or Enzalutamide33
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel-2.219.3Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide2.719.9Not reportedNot reportedNot reported
Cycle 8

Analysis denominator · Participants

GroupSource count
Cabazitaxel47
Abiraterone Acetate or Enzalutamide25
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel-4.820.4Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide0.823.0Not reportedNot reportedNot reported
End of treatment

Analysis denominator · Participants

GroupSource count
Cabazitaxel51
Abiraterone Acetate or Enzalutamide31
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cabazitaxel-6.316.1Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide-7.515.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.3
        value
        2.6
      2. group Id
        OG001
        spread
        12.4
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        106
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.1
        value
        2.7
      2. group Id
        OG001
        spread
        16.8
        value
        -1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        99
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.8
        value
        2.8
      2. group Id
        OG001
        spread
        16.8
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      2. group Id
        OG001
        value
        77
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.9
        value
        2.1
      2. group Id
        OG001
        spread
        16.1
        value
        -1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Cycle 5
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.0
        value
        -3.7
      2. group Id
        OG001
        spread
        18.6
        value
        0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    Cycle 6
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.3
        value
        -2.2
      2. group Id
        OG001
        spread
        19.9
        value
        2.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    Cycle 7
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.4
        value
        -4.8
      2. group Id
        OG001
        spread
        23.0
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Cycle 8
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.1
        value
        -6.3
      2. group Id
        OG001
        spread
        15.7
        value
        -7.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    End of treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Health-related quality of life (HRQOL) evaluation was performed using the FACT-P questionnaire (Version 4). FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted 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 total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms. Baseline corresponded to last evaluable assessment before treatment administration.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    id
    OG000
    title
    Cabazitaxel
  2. description
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    id
    OG001
    title
    Abiraterone Acetate or Enzalutamide
param Type
MEAN
population Description
Analysis was performed on HRQOL population which included participants who received at least one dose of the study drug and with an evaluable FACT-P questionnaire at baseline and at least one post-baseline evaluable FACT-P. Here 'Number analyzed' signifies participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to 141 weeks)
title
Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice