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NCT00079001 · OUTCOME

Progression-free Survival

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases · Source last updated 2020-05-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 10 years

What was measured

Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment.

Groups in this outcome

Zoledronic Acid + Androgen Deprivation Therapy

4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).

Placebo + Androgen Deprivation Therapy

Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.

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

Analysis denominator · Participants

GroupSource count
Zoledronic Acid + Androgen Deprivation Therapy323
Placebo + Androgen Deprivation Therapy322

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zoledronic Acid + Androgen Deprivation Therapy10.6Not reported8.515.4Not reported
Placebo + Androgen Deprivation Therapy9.2Not reported8.011.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.07
    estimate Comment
    Zoledronic acid versus placebo group
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.22
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Comment
    Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.07
    estimate Comment
    Zoledronic acid versus placebo group
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.22
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Comment
    Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.5
        upper Limit
        15.4
        value
        10.6
      2. group Id
        OG001
        lower Limit
        8.0
        upper Limit
        11.9
        value
        9.2
denoms
  1. counts
    1. group Id
      OG000
      value
      323
    2. group Id
      OG001
      value
      322
    units
    Participants
description
Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
    id
    OG000
    title
    Zoledronic Acid + Androgen Deprivation Therapy
  2. description
    Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
    id
    OG001
    title
    Placebo + Androgen Deprivation Therapy
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 10 years
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice