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NCT00470834 · ClinicalTrials.gov registry record · Phase 4
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
A Phase 4 study of Neoplasms Prostate, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
- 20
- Study locations
NCT00470834: Completed Phase 4 study of Neoplasms Prostate, sponsored by GlaxoSmithKline.
NCT00470834 is a Phase 4 study of Neoplasms Prostate that has completed, run by GlaxoSmithKline. The registered enrollment target is 127 participants, below the 3,087-participant average among 6 other Neoplasms Prostate trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00470834, a Phase 4 study of Neoplasms Prostate, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
- 20
- Study locations
Study Summary
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
Primary Outcome
Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter \[ng/mL\] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadi
Conditions Studied
Interventions
- DRUG placebo
- DRUG bicalutamide
- DRUG dutasteride
Study Locations (20)
California
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Fresno
- GSK Investigational Site - San Bernardino
- GSK Investigational Site - San Diego
Florida
- GSK Investigational Site - Aventura
- GSK Investigational Site - Daytona Beach
- GSK Investigational Site - Orlando
Indiana
- GSK Investigational Site - Evansville
- GSK Investigational Site - Fort Wayne
- GSK Investigational Site - Jeffersonville
Alabama
- GSK Investigational Site - Homewood
- GSK Investigational Site - Huntsville
Louisiana
- GSK Investigational Site - New Orleans
- GSK Investigational Site - Shreveport
Arkansas
- GSK Investigational Site - Little Rock
Colorado
- GSK Investigational Site - Denver
District of Columbia
- GSK Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT00470834 record still lists
NCT00470834 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 3,087-participant average among 6 other Neoplasms Prostate trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Neoplasms Prostate appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT00470834 names 20 study sites across 11 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00470834 about?
NCT00470834 is a clinical study titled "Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy". Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy...
What is the current status of trial NCT00470834?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2007-05. Estimated completion is 2013-02.
What conditions does trial NCT00470834 study?
This clinical trial studies the following conditions: Neoplasms Prostate.
What interventions are being tested in trial NCT00470834?
The interventions under investigation include: placebo (DRUG), bicalutamide (DRUG), dutasteride (DRUG).
Who is sponsoring clinical trial NCT00470834?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00470834 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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