The specific aims of this study are to : 1) establish the natural history of BPH; 2) investigate the potential effects of early pharmacologic intervention; 3) establish short-term adverse effects; and 4) seek easily measured predictors of outcome. To accomplish these aims,, a pilot study will be conducted at 4 clinical centers to: 1) determine recruitment statistics; 2) observe short-term adverse effects; 3) evaluate the use of recently emerged or novel modalities to monitor subtle disease progression and therefore enhance the power analysis for the main study. To these ends, four clinical centers will each randomize 25 minimally symptomatic patients over a 12 month period to terazosin, finasteride or placebo in a blinded fashion. Outcome variables will consist of AUA-7 symptom score, micturitional urethral pressure differentials and pressure flow analysis. Potential predictors of response will include morphometric analysis of transitional zone prostate biopsies, androgen receptor expression studies (direct and indirect) and prostate specific antigen (PSA) density utilizing serum PSA and total gland versus transitional zone volume. Tissue cores will be snap frozen and banked to allow mRNA analysis of patients already accrued as the rapidly expanding field of molecular biology develops.
