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NCT00417079 · OUTCOME

Time to Prostatic Specific Antigen (PSA) Progression

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer · Source last updated 2011-03-10

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
at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)

What was measured

In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later. In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.

Analysis population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

Groups in this outcome

Mitoxantrone + Prednisone

mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily

Cabazitaxel + Prednisone

cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily

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

Analysis denominator · Participants

GroupSource count
Mitoxantrone + Prednisone377
Cabazitaxel + Prednisone378

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mitoxantrone + Prednisone3.1Not reported2.24.4Not reported
Cabazitaxel + Prednisone6.4Not reported5.17.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    param Type
    Cox Proportional Hazard
    param Value
    0.75
    statistical Comment
    Log-rank comparisons stratified according to disease measurability and ECOG performance status.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    param Type
    Cox Proportional Hazard
    param Value
    0.75
    statistical Comment
    Log-rank comparisons stratified according to disease measurability and ECOG performance status.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        4.4
        value
        3.1
      2. group Id
        OG001
        lower Limit
        5.1
        upper Limit
        7.3
        value
        6.4
denoms
  1. counts
    1. group Id
      OG000
      value
      377
    2. group Id
      OG001
      value
      378
    units
    Participants
description
In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later. In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
dispersion Type
95% Confidence Interval
groups
  1. description
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    id
    OG000
    title
    Mitoxantrone + Prednisone
  2. description
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    id
    OG001
    title
    Cabazitaxel + Prednisone
param Type
MEDIAN
population Description
Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
reporting Status
POSTED
time Frame
at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
title
Time to Prostatic Specific Antigen (PSA) Progression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice