Primary Outcome Measures:
- Decrease of ≥ 50% in the proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging at baseline and at 6 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of dutasteride as assessed by NCI-CTCAE v3.0 [ Designated as safety issue: Yes ]
- Temporal and magnitude of change in serum-free and total prostate-specific antigen (PSA), dihydrotestosterone, and testosterone [ Designated as safety issue: No ]
- Symptom and quality-of-life indices [ Designated as safety issue: No ]
OBJECTIVES:
Primary
- To determine whether there is a decrease in the extent of prostate cancer as measured by endorectal MRI and magnetic resonance spectroscopy imaging in patients with symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with dutasteride for 6 months.
Secondary
- To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and free and total prostate-specific antigen (PSA).
- To monitor the effects of dutasteride on symptom and quality-of-life indices.
OUTLINE: Patients receive oral dutasteride once daily for 6 months.
Patients undergo endorectal MRI and magnetic resonance spectroscopy imaging at baseline and at 1, 3, and 6 months.
Patients complete quality-of-life questionnaires using the International Index of Erectile Function Questionnaire, American Urological Association Symptom Index, Functional Alterations due to Changes in Elimination, and Spitzer Quality-of-Life Index at baseline and at 1, 3, and 6 months.