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NCT00065442 · OUTCOME

Overall Survival

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy · Source last updated 2010-09-06

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
Event-driven timeframe. Final analysis at 331 events.

What was measured

Time from randomization until death due to any cause.

Groups in this outcome

APC-Placebo

All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.

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 consists of 3 doses administered approximately 2 weeks apart.

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

Analysis denominator · Participants

GroupSource count
APC-Placebo171
Sipuleucel-T341

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
APC-Placebo21.7Not reported17.723.8Not reported
Sipuleucel-T25.8Not reported22.827.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.614
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.979
    estimate Comment
    sipuleucel-T/placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.032
    param Type
    Hazard Ratio (HR)
    param Value
    0.775
    statistical Comment
    Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.608
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.965
    estimate Comment
    Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.023
    param Type
    Hazard Ratio (HR)
    param Value
    0.766
    statistical Comment
    Stratified by randomization strata.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.614
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.979
    estimate Comment
    sipuleucel-T/placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.032
    param Type
    Hazard Ratio (HR)
    param Value
    0.775
    statistical Comment
    Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.608
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.965
    estimate Comment
    Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.023
    param Type
    Hazard Ratio (HR)
    param Value
    0.766
    statistical Comment
    Stratified by randomization strata.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.7
        upper Limit
        23.8
        value
        21.7
      2. group Id
        OG001
        lower Limit
        22.8
        upper Limit
        27.7
        value
        25.8
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      341
    units
    Participants
description
Time from randomization until death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
    id
    OG000
    title
    APC-Placebo
  2. 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 consists of 3 doses administered approximately 2 weeks apart.
    id
    OG001
    title
    Sipuleucel-T
param Type
MEDIAN
reporting Status
POSTED
time Frame
Event-driven timeframe. Final analysis at 331 events.
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice