The clinical spectrum of benign prostatic hyperplasia (BPH) ranges from only slightly bothersome urinary symptoms to life threatening events. Transurethral resection of the prostate (TURP) currently represents the only widely accepted treatment for BPH. Approximately 30% of 50 year old men will undergo a TURP by age 80. Since the spectrum of clinical BPH is so diverse, it is difficult to imagine that this disease process can be optimally treated by a single surgical procedure. The exclusive role of TURP for the treatment of BPH is presently under intense scrutiny since there is increasing evidence that medical therapies are also effective treatment options. The development of a rational approach for the medical management of BPH is presently not feasible since randomized placebo controlled studies comparing the safety and effectiveness of different medical therapies have not been reported, parameters predicting therapeutic response to medical therapies have not been identified, and guidelines to exclude prostate cancer have not been established. The 7 specific aims of the grant proposal are designed to ascertain the safety and effectiveness of alpha blockade, androgen suppression and combination therapy (alpha blockade + androgen suppression) for BPH; identify clinical, urodynamic, and histologic factors that predict therapeutic response to medical therapy; determine whether serum PSA levels are directly correlated with the total amount of prostatic epithelium; and determine whether prostate cancer can be reliably excluded on the basis of digital rectal examination and serum PSA levels. Terazosin and finasteride were selected as the pharmacologic agents since both drugs have been extensively studied in males with BPH. A total of 100 subjects will be enrolled into the 4 arm randomized placebo controlled pilot study. The primary outcome measures will include AUA symptom scores and quality of life score. The inclusion and exclusion criteria will define a cohort of subjects with clinically significant BPH lacking absolute indications for intervention. Prostatic tissue will be analyzed in order to provide insights related to detecting prostate cancer and predicting therapeutic response to medical therapy.
