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NCT00514917 · ClinicalTrials.gov registry record · Phase 3

A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

A Phase 3 study, sponsored by Sanofi.

Terminated
Registry status
Phase 3
Development phase
413
Enrollment target

NCT00514917 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 413 participants.

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The verdict

NCT00514917, a Phase 3 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 3
Development phase
413 participants
Enrollment target

Study Summary

The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up. The secondary objectives were: * To assess cancer specific survival; * To compare overall survival between the 2 treatment groups; * To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.

Interventions

  • DRUG Docetaxel
  • DRUG Bicalutamide
  • DRUG Leuprolide

Trial Details

FieldValue
Enrollment Target 413 participants
Start Date 2007-07
Est. Completion 2012-09
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00514917

The ClinicalTrials.gov registry entry for NCT00514917 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.

NCT00514917 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00514917 about?

NCT00514917 is a clinical study titled "A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)". The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up. The secondary objectives were: * To assess cancer specif...

What is the current status of trial NCT00514917?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2007-07. Estimated completion is 2012-09.

What interventions are being tested in trial NCT00514917?

The interventions under investigation include: Docetaxel (DRUG), Bicalutamide (DRUG), Leuprolide (DRUG).

Who is sponsoring clinical trial NCT00514917?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.