Background: "in vivo" application of a new echographic method able to better identify neoplastic tissue. The aim of this study was to evaluate its accuracy in the diagnosis of prostate cancer.
Materials and methods: Double-blind prospective study on 60 patients (pts) submitted to both transrectal ultrasound (TRUS) of prostate with a traditional echograph connected to a new hardware/software platform named FEMMINA (Fast Echographic Multiparameter Multi Image Novel Apparatus) that processes the echo signal by RULES (Radiofrequency Ultrasonic Local EStimators) algorithm and to a prostatic biopsy (8 to 12 cores). Histological findings of biopsies were compared to B-mode and the new ultrasound method.
Results: Cancer was detected in 18/60 pts. 14 patients had positive images with RULES, 11 with B-mode modality. The positive predictive value (PPV) and negative predictive value (NPV) of B-mode were 42% and 79% while 77% and 90% of RULES. Sensitivity and specificity of B-mode were 61% and 79% while those of RULES were 77% and 90%. B-mode diagnostic accuracy was 63% and RULES accuracy was 86%.
Conclusions: Results obtained with RULES are encouraging but they need further studies for its application in clinical practice.