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NCT00005044 · OUTCOME

Overall Survival (OS) (10-year Rates Reported)

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer · 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 randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

What was measured

Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.

Analysis population: Eligible patients with follow-up data

Groups in this outcome

TAS x 8 Weeks

Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).

TAS x 28 Weeks

TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).

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

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks752
TAS x 28 Weeks737

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks66Not reported6270Not reported
TAS x 28 Weeks67Not reported6371Not 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
    1.15
    estimate Comment
    Reference level = TAS x 8 weeks
    group Description
    With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.62
    param Type
    Hazard Ratio (HR)
    param Value
    0.95
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    estimate Comment
    Reference level = TAS x 8 weeks
    group Description
    With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.62
    param Type
    Hazard Ratio (HR)
    param Value
    0.95
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62
        upper Limit
        70
        value
        66
      2. group Id
        OG001
        lower Limit
        63
        upper Limit
        71
        value
        67
denoms
  1. counts
    1. group Id
      OG000
      value
      752
    2. group Id
      OG001
      value
      737
    units
    Participants
description
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
    id
    OG000
    title
    TAS x 8 Weeks
  2. description
    TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
    id
    OG001
    title
    TAS x 28 Weeks
param Type
NUMBER
population Description
Eligible patients with follow-up data
reporting Status
POSTED
time Frame
From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
title
Overall Survival (OS) (10-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