At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 127 enrolled
Drug / intervention
dutasteride +2 moredrug
Likely dose
dutasteride 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating dutasteride, placebo, and 1 other intervention for Neoplasms, Prostate. Completed, enrolled 127 participants across 62 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Prostate
CountriesCanada, United States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionFeb 2013
TodayJul 2026
First PostedMay 8, 2007
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.2 years ago
Interventions
dutasteridedrug
0.5mg dutasteride (Investigation Product)
placebodrug
making placebo
bicalutamidedrug
50 mg Casodex or generic equivalent