Patients with abnormal ultrasound of the prostate but normal digital rectal examination should be classified as having clinical stage T2 tumors

Purpose: The current TNM staging system classifies prostate tumors with abn ormal transrectal ultrasound but normal digital rectal examination as clini cal stage T2. However, most urologists consider these tumors as clinical st age Tie due to the perceived inaccuracy of transrectal ultrasound in clinic al staging. To determine the role of transrectal ultrasound in the clinical staging of prostate cancer we evaluated the pathological stage and disease -free survival of patients undergoing radical prostatectomy who had tumor d etected by needle biopsy because of elevated serum prostate specific antige n with or without transrectal ultrasound abnormalities. Materials and Methods: Between 1991 and 1996, 738 patients underwent radical retropubic p rostatectomy as monotherapy for clinically localized prostate cancer. Patie nts were classified into group 1-normal digital rectal examination and tran srectal ultrasound (138), group 2-normal digital rectal examination but abn ormal transrectal ultrasound (366) and group 3 -abnormal digital rectal exa mination (234), We compared pathological parameters and disease-free-surviv al among the 3 groups. Results: Tumors were organ confined in 61%, 42% and 41% of patients in grou ps 1, 2 and 3, respectively (p = 0.0001). Overall disease-free survival was 80% with a mean followup of 68 months. Disease recurred in 8%, 22% and 25% of patients in groups 1, 2 and 3, respectively (p = 0.007). Group 1 had be tter disease-free survival compared to groups 2 and 3 (p = 0.003 and p = 0. 002, respectively), and there was no difference in disease-free survival be tween groups 2 and 3 (p = 0.39). Conclusions: We provide evidence to support the use of transrectal ultrasou nd findings in the clinical staging system for prostate cancer. Patients wi th normal digital rectal examination, elevated serum prostate specific anti gen and abnormal transrectal ultrasound should be considered as having clin ical stage T2 disease.