Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

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.

Timeline

Start

2007-05

Primary completion

2013-02

Completion

2013-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Bicalutamide 50 mg/Placebo vs Bicalutamide 50 mg/Dutasteride 3.5 mg; p = 0.79; Log Rank NCT00470834 ↗

Drugs

Indications