important to obviate bias when we use nomograms from dif- ferent academic centres. 05 Intrarectal cooled lignocaine gel for pain control during transrectal prostate biopsy Og ˇuzu ¨ lgen AI ˙ , Tekin MI ˙ ,O ¨ zkardes ¸H Department of Urology, Bas ¸kent University School of Medicine, Ankara, Turkey Objectives: To evaluate the safety and efficacy of intrarectal cooled lignocain gel as anaesthesia during prostate biopsy. Methods: Fifty consenting men who underwent transrectal prostate biopsy were randomised to receive 11 mL of 2% ligno- caine gel (Instillagel ® ) intrarectally at 4° (group 1, n=25) and at room tempareture (group 2, n=25), 10 minutes before the procedure. All patients were treated with 100 mg tramadol hydrochloride orally 60 minutes before the biopsy. Indica- tions for the procedure were an abnormal prostate on digital rectal examination and/or elevated serum prostate specific an- tigen (PSA) levels. Pain during transrectal ultrasound and bi- opsy was assessed using a 10-point linear visual analogue pain scale. Results: In groups 1 and 2 the mean patient age was 66.99.7 and 64.47.6 years, respectively. In group 1 median PSA was 8.2 ng/ml (range 4.01-254.9) whereas it was 7 ng/ml (range 0.8-146) in group 2. Digital rectal examinations were normal in 16 group 1 and in 11 group 2 patients. Median prostate volume was 50.2 mL in group 1 (range 23.5-80.1) and 43.1 mL (range 15.3-99.2) in group 2. The mean pain scores during transrectal ultrasound were not statistically different in two groups (1.08 and 2.08, respectively). But the pain scores in prostate biopsy were significantly lower in group 1 (3.52 vs 6.08, p=0.000). No adverse event was seen after the proce- dures except one case of acute prostatitis in group 2. Conclusions: Intrarectal application of a gel with local anes- thetic seems useful before transrectal ultrasonography and bi- opsy. Cooling the same gel before application appears more effective for reducing pain during biopsy. 06 Real-time tissue elasticity imaging (Elastography) for prostate cancer detection Tsutsumi M 1 , Miyakawa T 1 , Ishikawa S 1 , Matsumura T 2 , Shiina T 3 , Miyanaga N 3 , Akaza H 3 1 Hitachi General Hospital, Hitachi, Japan, 2 Hitachi Medical Cor- poration, Kashiwa, Japan, 3 Tsukuba University, Tsukuba, Japan Introduction: The ultrasound real-time elasticity imaging sys- tem (elastography) is a new technology, which visualizes the difference in the tissue strain by freehand compression. Elas- tography is recently indicated for the breast tissue diagnosis, and the first trial for prostate cancer was presented by Miy- anaga et al (J Urol 171 suppl:474-475, 2004). We performed trans-rectal ultrasonic (TRUS) biopsy of the prostate concom- itantly with elastography, and evaluated the feasibility and efficacy in the diagnosis of prostate cancer. Methods: A total of 223 cases (66 years old on average, PSA: 7.9 ng/ml on average) underwent elastography concomitantly with TRUS biopsy. The trans-rectal probe was a 7.5-MHz mu- tually perpendicular bi-plane probe equipped with dual 10R convex heads (EUP-CC531, Hitachi Medical Corporation, To- kyo, Japan), which simultaneously enables TRUS biopsy and elastography. The distribution of the tumor as shown by elas- tography and preoperative MRI were compared with that seen in the pathological sections in 40 resected prostates. Results: We succeeded in obtaining tissue strain distribution. Seventy-seven prostate cancers were found. The positive and negative predictive values of elastography were 45% and 79%, respectively. The sensitivity and specificity of cancer were 69% and 59%, respectively. These results are superior to those of B-mode examination. An anterior tumor is easily detected by elastography despite of negative B-mode findings. Fifty-five percent of the elastography and 68% of MRI agreed with those of the pathological section. Together with B-mode and elas- tography reached the same accuracy as MRI, and is superior because of the ability of concomitant TRUS biopsy. The agree- ment of pathology and elastography in the anterior lesion was superior to that of posterior lesion (62% vs 44%), and high Gleason scored tumor tends to be positive findings (17%, 57%, 71% in Gleason sum. 6,7, 89, respectively). Conclusions: Real-time examination by elastography and TRUS biopsy is feasible and effective, and is promising for the detection of T1c prostate cancer, especially in anterior low grade tumor. Two problems still exist: 1. Prostate hypertrophy was often recognized as hard, which led to low positive pre- dictive value. 2. Peripheral cancer somehow showed as false- negative, despite a palpable tumor. 07 APTIMA® PCA3 Molecular Urine Test: Development of a Method to Aid in the Diagnosis of Prostate Cancer Giachetti C 1 , Groskopf J 1 , Walker S 1 , Deras I 1 , Clark C 1 , Bodrug S 1 , Blase A 1 , Brentano S 1 , Rittenhouse H 1 , Desaulniers M 2 , Chypre C 2 , Fradet Y 2 1 Gen-Probe Incorporated, San Diego, CA, 2 DiagnoCure Incorpo- rated, Quebec, Canada Introduction: PCA3 is a prostate-specific mRNA that is highly over-expressed in prostate cancer cells. The APTIMA PCA3 amplified nucleic acid assay currently in development utilizes Transcription-Mediated Amplification (TMA) to quantify PCA3 and PSA mRNA derived from prostate cells in whole urine and urine pellets. The test is being developed to improve the clinical evaluation of prostate disease. Methods: The study consisted of men scheduled for biopsy (n=93) or radical prostatectomy (n=26). Fifty-three of 119 enrolled patients tested cancer-positive upon biopsy; 66 tested negative including 20 with prostatic intraepithelial neoplasia or atypical small acinar proliferation. An additional group of men (n=31) who had undergone radical prostatectomy one or more years previously, served as a control group. Urine sam- ples were collected from all subjects post-digital rectal exam (DRE), with centrifuged (pelleted) and uncentrifuged (whole) urine stabilized in lysis buffer for analysis. PCA3 and prostate- specific antigen (PSA) mRNA were isolated, amplified and quantified with a prototype assay that utilizes Gen-Probe’s magnetic Target Capture, TMA, and Hybridization Protection Assay technologies. PSA mRNA was used to normalize the PCA3 signal and to confirm the presence of prostate-specific mRNA in the sample. Results: For the whole urine samples, the prototype APTIMA PCA3 assay yielded a sensitivity of 66% and specificity of 75%. The area under the receiver operating characteristics curve UROLOGY 66 (Supplement 3A), September 2005 3