Conditions: Neoplasms, Prostate
Keywords: Prostate cancer prevention prostate BPH enlarged prostate PSA prostate cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8231
Healthy volunteers: no

Brief summary:
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Detailed description:

Arms:
arm 1: Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio. arm 2: Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center.

Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years. intervention 2: After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.

Protocol document: