Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00309985 · OUTCOME

Time to Clinical Progression

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer · Source last updated 2025-12-11

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
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

What was measured

Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

Analysis population: All randomized patients.

Groups in this outcome

Androgen-Deprivation Therapy and Docetaxel

Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Androgen-Deprivation Therapy Alone

Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).

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

Analysis denominator · Participants

GroupSource count
Androgen-Deprivation Therapy and Docetaxel397
Androgen-Deprivation Therapy Alone393

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Androgen-Deprivation Therapy and Docetaxel33.0Not reported27.341.2Not reported
Androgen-Deprivation Therapy Alone19.8Not reported17.922.8Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.3
        upper Limit
        41.2
        value
        33.0
      2. group Id
        OG001
        lower Limit
        17.9
        upper Limit
        22.8
        value
        19.8
denoms
  1. counts
    1. group Id
      OG000
      value
      397
    2. group Id
      OG001
      value
      393
    units
    Participants
description
Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Androgen-Deprivation Therapy and Docetaxel
  2. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    id
    OG001
    title
    Androgen-Deprivation Therapy Alone
param Type
MEDIAN
population Description
All randomized patients.
reporting Status
POSTED
time Frame
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
title
Time to Clinical Progression
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice