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NCT00309985 · OUTCOME

QOL Change From Baseline to 3 Months

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer · Source last updated 2025-12-11

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 Error
Time frame
Assessed at baseline and 3 months

What was measured

The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.

Analysis population: Patients with both baseline and 3-month QOL assessments are included in this analysis.

Groups in this outcome

Androgen-Deprivation Therapy and Docetaxel

Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Androgen-Deprivation Therapy Alone

Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).

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

Analysis denominator · Participants

GroupSource count
Androgen-Deprivation Therapy and Docetaxel334
Androgen-Deprivation Therapy Alone299

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Androgen-Deprivation Therapy and Docetaxel-2.70.9Not reportedNot reportedNot reported
Androgen-Deprivation Therapy Alone-1.11.0Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0009
    statistical Method
    Wilcoxon signed rank test
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.40
    statistical Method
    Wilcoxon signed rank test
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0009
    statistical Method
    Wilcoxon signed rank test
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.40
    statistical Method
    Wilcoxon signed rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9
        value
        -2.7
      2. group Id
        OG001
        spread
        1.0
        value
        -1.1
denoms
  1. counts
    1. group Id
      OG000
      value
      334
    2. group Id
      OG001
      value
      299
    units
    Participants
description
The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
dispersion Type
Standard Error
groups
  1. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Androgen-Deprivation Therapy and Docetaxel
  2. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    id
    OG001
    title
    Androgen-Deprivation Therapy Alone
param Type
MEAN
population Description
Patients with both baseline and 3-month QOL assessments are included in this analysis.
reporting Status
POSTED
time Frame
Assessed at baseline and 3 months
title
QOL Change From Baseline to 3 Months
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice