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NCT00887198 · OUTCOME

Time to Prostate-specific Antigen (PSA) Progression

Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer · Source last updated 2025-02-04

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
From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

What was measured

The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.

Analysis population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

Groups in this outcome

Abiraterone Acetate + Prednisone (AAP)

Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

Placebo

Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical 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 Acetate + Prednisone (AAP)546
Placebo542

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abiraterone Acetate + Prednisone (AAP)11.07Not reported8.5111.24Not reported
Placebo5.55Not reported5.395.59Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.51
        upper Limit
        11.24
        value
        11.07
      2. group Id
        OG001
        lower Limit
        5.39
        upper Limit
        5.59
        value
        5.55
denoms
  1. counts
    1. group Id
      OG000
      value
      546
    2. group Id
      OG001
      value
      542
    units
    Participants
description
The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    id
    OG000
    title
    Abiraterone Acetate + Prednisone (AAP)
  2. description
    Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
title
Time to Prostate-specific Antigen (PSA) Progression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice