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NCT00002874 · OUTCOME

Non-Prostate Cancer Death (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

Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death 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. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition.

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
Placebo15.3Not reported11.819.3Not reported
Bicalutamide17.9Not reported14.022.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.53
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Reference level = placebo arm
    p Value
    0.289
    param Type
    Cox Proportional Hazard
    param Value
    1.10
    statistical Comment
    One-sided test
    statistical Method
    Gray's test
Complete source fields
analyses
  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.53
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Reference level = placebo arm
    p Value
    0.289
    param Type
    Cox Proportional Hazard
    param Value
    1.10
    statistical Comment
    One-sided test
    statistical Method
    Gray's test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.8
        upper Limit
        19.3
        value
        15.3
      2. group Id
        OG001
        lower Limit
        14.0
        upper Limit
        22.1
        value
        17.9
denoms
  1. counts
    1. group Id
      OG000
      value
      376
    2. group Id
      OG001
      value
      384
    units
    Participants
description
Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death 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. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition.
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
Non-Prostate Cancer Death (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