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NCT01212991 · OUTCOME

Best Overall Soft Tissue Response

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer · Source last updated 2020-03-17

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
During study period (up to 3 years)

What was measured

The best overall soft tissue objective response is defined as partial response \[PR\] or complete response \[CR\] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.

Analysis population: Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.

Groups in this outcome

Enzalutamide

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

Placebo

Participants received placebo, administered as four capsules, once per day by mouth.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide396
Placebo381

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enzalutamide58.8Not reportedNot reportedNot reportedNot reported
Placebo5.0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    48.53
    ci Pct Value
    95
    ci Upper Limit
    59.17
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.
    param Type
    Difference in objective response rate
    param Value
    53.85
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    48.53
    ci Pct Value
    95
    ci Upper Limit
    59.17
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.
    param Type
    Difference in objective response rate
    param Value
    53.85
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58.8
      2. group Id
        OG001
        value
        5.0
denoms
  1. counts
    1. group Id
      OG000
      value
      396
    2. group Id
      OG001
      value
      381
    units
    Participants
description
The best overall soft tissue objective response is defined as partial response \[PR\] or complete response \[CR\] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.
groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    OG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.
reporting Status
POSTED
time Frame
During study period (up to 3 years)
title
Best Overall Soft Tissue Response
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice