Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00005947 · OUTCOME

Overall Survival

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy · Source last updated 2010-11-01

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
From randomization to 36 months

What was measured

Overall Survival

Groups in this outcome

Sipuleucel-T

All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.

Placebo

All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.

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

Analysis denominator · Participants

GroupSource count
Sipuleucel-T82
Placebo45

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sipuleucel-T25.9Not reported20.032.4Not reported
Placebo21.4Not reported12.325.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.13
    ci Pct Value
    95
    ci Upper Limit
    2.58
    estimate Comment
    Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].
    group Description
    ITT Population - all randomized participants
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Hazard Ratio (HR)
    param Value
    1.71
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.388
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.884
    estimate Comment
    Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]
    group Description
    ITT Population - all randomized participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Hazard Ratio (HR)
    param Value
    0.586
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.13
    ci Pct Value
    95
    ci Upper Limit
    2.58
    estimate Comment
    Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].
    group Description
    ITT Population - all randomized participants
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Hazard Ratio (HR)
    param Value
    1.71
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.388
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.884
    estimate Comment
    Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]
    group Description
    ITT Population - all randomized participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Hazard Ratio (HR)
    param Value
    0.586
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        32.4
        value
        25.9
      2. group Id
        OG001
        lower Limit
        12.3
        upper Limit
        25.8
        value
        21.4
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      45
    units
    Participants
description
Overall Survival
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
    id
    OG000
    title
    Sipuleucel-T
  2. description
    All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
reporting Status
POSTED
time Frame
From randomization to 36 months
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice