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NCT00974311 · OUTCOME

Percentage of Participants With Circulating Tumor Cell (CTC) Conversion

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy · Source last updated 2018-12-11

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
95% Confidence Interval
Time frame
Baseline up to 24 months

What was measured

CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (\>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (\<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.

Analysis population: CTC evaluable population included participants with a baseline and at least 1 post baseline CTC assessment.

Groups in this outcome

Enzalutamide

In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).

Placebo

In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).

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

Analysis denominator · Participants

GroupSource count
Enzalutamide127
Placebo62

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide48Not reported39.0957.07Not reported
Placebo9.7Not reported3.6319.88Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.09
        upper Limit
        57.07
        value
        48
      2. group Id
        OG001
        lower Limit
        3.63
        upper Limit
        19.88
        value
        9.7
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      62
    units
    Participants
description
CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (\>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (\<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
    id
    OG000
    title
    Enzalutamide
  2. description
    In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
CTC evaluable population included participants with a baseline and at least 1 post baseline CTC assessment.
reporting Status
POSTED
time Frame
Baseline up to 24 months
title
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice