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NCT00002597 · OUTCOME

Positive Re-biopsy Rate at Two 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
Not reported
Time frame
From registration to two years

What was measured

The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.

Analysis population: All eligible patients who had a repeat biopsy at 2 years.

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 Therapy439
Radiation Therapy Alone404

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hormone Therapy + Radiation Therapy20.2Not reportedNot reportedNot reportedNot reported
Radiation Therapy Alone38.9Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20.2
      2. group Id
        OG001
        value
        38.9
denoms
  1. counts
    1. group Id
      OG000
      value
      439
    2. group Id
      OG001
      value
      404
    units
    Participants
description
The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.
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 who had a repeat biopsy at 2 years.
reporting Status
POSTED
time Frame
From registration to two years
title
Positive Re-biopsy Rate at Two Years
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice