To determine the ability of transrectal ultrasound to detect early localized prostate cancer, unsuspected (nonpalpable) cancer in the contralateral lobe of patients undergoing radical prostatectomy for clinically localized disease was evaluated. A total of 59 patients with palpable prostate cancer clinically confined to 1 lobe underwent transrectal ultrasound before radical prostatectomy and step-sectioning of the radical prostatectomy specimen. Transrectal ultrasound was performed with 5 or 7 MHz. real-time transrectal units. Pathological findings in these 59 cases revealed no tumor in the contralateral lobe in 34 (58%) and the presence of unsuspected tumor in 25 (42%). Transrectal ultrasound detected 13 of 25 unsuspected cancers for a sensitivity of 52%. Of 34 patients with no contralateral lobe lesion transrectal ultrasound was correct in 23 for a specificity of 68%. The positive and negative predictive values for transrectal ultrasound in this study group were 54 and 66%, respectively. There was no significant difference in the pathological size of the clinically suspected and clinically unsuspected cancers as measured by average largest dimension, and transrectal ultrasound sensitivity did not correlate with the size of the cancer. Based on careful sonopathological analysis, transrectal ultrasound may not be a good method to detect clinically unsuspected prostate cancer and the false positive rate would appear to be high.