| Exclusion Criteria: | 1) A subject will be eligibe for inclusion in this study only if all of the following criteria apply. More than one prior negative prostate biopsy
2) History of prostate cancer
3) Evidence of high grade PIN or atypical small acinar proliferation (ASAP) on entry prostate biopsy
4) Prostate volume >80cc
5) Previous prostate surgery (including transurethral resection of the prostate [TURP], balloon dilatation, thermotherapy, stent placement)
6) Severe prostatism as manifested by an IPSS symptom score (calculated using the first 7 questions only) of greater than or equal to 25 or greater than or equal to 20 if already on alpha blocker therapy for BPH
7) Post-void residual volume >200mL at screening Visit 1
8) Peak flow rate (Qmax) below 5mL/sec
9) History of acute urinary retention during the previous 2 years (a single episode of drug-induced AUR is acceptable)
10) Any causes other than BPH, which may, in the judgment of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute prostatitis, acute bacterial prostatitis within 6 months of study entry, or acute or chronic urinary tract infections)
11) Prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible (NOTE: T1a bladder cancer with negative surveillance cystoscopy within the past 2 years may be included).
12) Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
13) Abnormal liver function test. (greater than 2 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal
14) Serum creatinine >1.5 times the upper limit of normal
15) Known hypersensitivity to any 5alpha-reductase inhibitor or drug chemically related to the study drug
16) Concurrent and/or previous use within the past 12 months of the following medications: · Finasteride (Proscar*., Propecia*.) · Any other investigational or marketed 5á-reductase inhibitors · Anabolic steroids drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, famotidine, ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the CRF.
17) Subjects who inadvertently take a few doses of drugs listed on the "prohibited list" will not be withdrawn from the study. Subjects are withdrawn at the discretion of the investigator for repeated violations.
18) Treatment with any other investigational agent not referenced in exclusion 16 above within the 30 days prior to the first dose of study drug or anytime during the study period.
19) History of current evidence of drug or alcohol abuse within the last 12 months. |