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NCT00002874 · OUTCOME

Second PSA Recurrence (12-year Rates Reported)

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy · Source last updated 2022-06-15

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to 12 years.

What was measured

Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (\<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to \>= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of \>= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of \>= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

Analysis population: Eligible patients who did not withdraw consent.

Groups in this outcome

Placebo

Radiation therapy (64.8 Gy) + placebo (daily 2 years)

Bicalutamide

Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)

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

Analysis denominator · Participants

GroupSource count
Placebo376
Bicalutamide384

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo67.9Not reported62.772.5Not reported
Bicalutamide44.0Not reported38.849.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.58
    estimate Comment
    Reference level = placebo arm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.48
    statistical Comment
    One-sided test
    statistical Method
    Gray's test
Complete source fields
analyses
  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.58
    estimate Comment
    Reference level = placebo arm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.48
    statistical Comment
    One-sided test
    statistical Method
    Gray's test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.7
        upper Limit
        72.5
        value
        67.9
      2. group Id
        OG001
        lower Limit
        38.8
        upper Limit
        49.1
        value
        44.0
denoms
  1. counts
    1. group Id
      OG000
      value
      376
    2. group Id
      OG001
      value
      384
    units
    Participants
description
Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (\<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to \>= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of \>= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of \>= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy (64.8 Gy) + placebo (daily 2 years)
    id
    OG000
    title
    Placebo
  2. description
    Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
    id
    OG001
    title
    Bicalutamide
param Type
NUMBER
population Description
Eligible patients who did not withdraw consent.
reporting Status
POSTED
time Frame
From date of randomization to 12 years.
title
Second PSA Recurrence (12-year Rates Reported)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice