Trials / Completed
CompletedNCT00470834
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Male
- Age
- 40 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dutasteride | 0.5mg dutasteride (Investigation Product) |
| DRUG | placebo | making placebo |
| DRUG | bicalutamide | 50 mg Casodex or generic equivalent |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2007-05-08
- Last updated
- 2017-02-27
- Results posted
- 2013-11-01
Locations
62 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00470834. Inclusion in this directory is not an endorsement.