DHAIS (Diagnosis-Helping-Accuracy-Imaging-Study) study: Combined endorectal MR and MR spectroscopic imaging in the diagnosis of prostate cancer

14562 Background: The DHAIS study is a prospective, three-step investigation, consisting in an initial two-step phase (Diagnosis-Accuracy) followed by an extension phase (Helping). The purpose was to compare endorectal MRI and MR spectroscopic imaging (MRSI) results with biopsy results (Diagnosis) and definitive histology after radical retropubic prostatectomy (RRP) (Accuracy). The helping extension will investigate the ability of combined MRI and MRSI to detect prostate cancer foci in men with prior negative prostate biopsy. Methods: MRI and MRSI were performed in 37 consecutive pts for increased PSA and/or abnormal rectal examination. A dedicated radiologist identified areas of interest as normal, equivocal or suspicious on MRI and MRSI separately. All pts underwent prostate biopsy (TRUS 10-core biopsy) by the urologist who was blind to imaging results. Patients with positive biopsies underwent RRP. MRI and MRSI results were compared to biopsy and step-section histology. Those pts with negative biopsies will underdo a second set of 10-core prostate biopsy with up to 4 additional biopsies targeted at the equivocal or suspected sites (Helping-phase). Results: Prostate cancer was detected in 8 of 37 subjects (21.6%). Six pts underwent RRP. The sensitivity, specificity, positive and negative predictive values (PPV, NPV) and the accuracy of MRI, MRSI and combined MRI/MRSI are shown in the Table. Conclusions: MRI and MRSI have the potential to identify cancer foci and potentially direct TRUS in patients undergoing TRUS biopsy. The third phase of this study could demonstrate the utility during repeated biopsies. Further larger studies are required to quantify the amount of benefit. [Table: see text] No significant financial relationships to disclose.