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NCT00638690 · OUTCOME

Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy · Source last updated 2014-04-30

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Up to 12 months

What was measured

The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.

Analysis population: Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.

Groups in this outcome

Abiraterone Acetate

Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.

Placebo

Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.

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

Analysis denominator · Participants

GroupSource count
Abiraterone Acetate797
Placebo398

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abiraterone Acetate309.0Not reported255.0421.0Not reported
Placebo200.0Not reported170.0254.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.462
    ci Pct Value
    95
    ci Upper Limit
    0.728
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Nominal P-value = 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.580
    statistical Comment
    This was a stratified analysis.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.462
    ci Pct Value
    95
    ci Upper Limit
    0.728
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Nominal P-value = 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.580
    statistical Comment
    This was a stratified analysis.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        255.0
        upper Limit
        421.0
        value
        309.0
      2. group Id
        OG001
        lower Limit
        170.0
        upper Limit
        254.0
        value
        200.0
denoms
  1. counts
    1. group Id
      OG000
      value
      797
    2. group Id
      OG001
      value
      398
    units
    Participants
description
The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
dispersion Type
95% Confidence Interval
groups
  1. description
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    id
    OG000
    title
    Abiraterone Acetate
  2. description
    Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
Up to 12 months
title
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice