Conditions: Neoplasms, Prostate
Keywords: prostate cancer androgen deprivation therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 50 mg bicalutamide and 3.5 mg Dutasteride (IP) arm 2: 50 mg bicalutamide and placebo

Interventions: intervention 1: dutasteride intervention 2: placebo intervention 3: bicalutamide
Intervention descriptions: intervention 1: 0.5mg dutasteride (Investigation Product) intervention 2: making placebo intervention 3: 50 mg Casodex or generic equivalent

Protocol document: