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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: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT00514917 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 413 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram p
Interventions
- DRUG Docetaxel
- DRUG Bicalutamide
- DRUG Leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
Why NCT00514917 stopped before completion
NCT00514917 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00514917 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00514917's enrollment target sits among peer trials
413 905th of 2000 higher than 1,095 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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