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NCT00002597 · OUTCOME

Clinical Relapse Rate (10 Years)

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer · Source last updated 2018-06-14

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 registration to 10 years

What was measured

Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.

Analysis population: All eligible patients.

Groups in this outcome

Hormone Therapy + Radiation Therapy

Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.

Radiation Therapy Alone

Radiation therapy alone

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

Analysis denominator · Participants

GroupSource count
Hormone Therapy + Radiation Therapy987
Radiation Therapy Alone992

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Hormone Therapy + Radiation Therapy15.0Not reported12.617.3Not reported
Radiation Therapy Alone21.7Not reported19.124.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.85
    estimate Comment
    Reference level = Hormone Therapy + Radiation Therapy
    group Description
    Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    1.5
    statistical Method
    Gray's test
Complete source fields
analyses
  1. ci Lower Limit
    1.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.85
    estimate Comment
    Reference level = Hormone Therapy + Radiation Therapy
    group Description
    Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    1.5
    statistical Method
    Gray's test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.6
        upper Limit
        17.3
        value
        15.0
      2. group Id
        OG001
        lower Limit
        19.1
        upper Limit
        24.4
        value
        21.7
denoms
  1. counts
    1. group Id
      OG000
      value
      987
    2. group Id
      OG001
      value
      992
    units
    Participants
description
Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
    id
    OG000
    title
    Hormone Therapy + Radiation Therapy
  2. description
    Radiation therapy alone
    id
    OG001
    title
    Radiation Therapy Alone
param Type
NUMBER
population Description
All eligible patients.
reporting Status
POSTED
time Frame
From registration to 10 years
title
Clinical Relapse Rate (10 Years)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice