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NCT00002874 · OUTCOME

PSA Complete Response at End of Protocol Treatment

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
End of protocol treatment, which is planned to last for two years

What was measured

Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA \< 05 ng/ml.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo259Not reportedNot reportedNot reportedNot reported
Bicalutamide360Not 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
        259
      2. group Id
        OG001
        value
        360
denoms
  1. counts
    1. group Id
      OG000
      value
      376
    2. group Id
      OG001
      value
      384
    units
    Participants
description
Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA \< 05 ng/ml.
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
COUNT_OF_PARTICIPANTS
population Description
Eligible patients who did not withdraw consent.
reporting Status
POSTED
time Frame
End of protocol treatment, which is planned to last for two years
title
PSA Complete Response at End of Protocol Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice