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NCT00033631 · OUTCOME

Percentage of Participants With Erectile Disfuction at 12 Months

Radiation Therapy in Treating Patients With Stage II Prostate Cancer · Source last updated 2023-01-18

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
Twelve months from randomization

What was measured

The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or \< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.

Analysis population: Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline

Groups in this outcome

70.2 Gy

70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.

79.2 Gy

79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.

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

Analysis denominator · Participants

GroupSource count
70.2 Gy134
79.2 Gy145

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
70.2 Gy38.06Not reported29.8446.28Not reported
79.2 Gy49.66Not reported41.5257.79Not reported

Source statistical analyses

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

  1. group Description
    With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0513
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0513
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.84
        upper Limit
        46.28
        value
        38.06
      2. group Id
        OG001
        lower Limit
        41.52
        upper Limit
        57.79
        value
        49.66
denoms
  1. counts
    1. group Id
      OG000
      value
      134
    2. group Id
      OG001
      value
      145
    units
    Participants
description
The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or \< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.
dispersion Type
95% Confidence Interval
groups
  1. description
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    id
    OG000
    title
    70.2 Gy
  2. description
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    id
    OG001
    title
    79.2 Gy
param Type
NUMBER
population Description
Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline
reporting Status
POSTED
time Frame
Twelve months from randomization
title
Percentage of Participants With Erectile Disfuction at 12 Months
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice