COMPARISON OF STANDARD 12 CORES SYSTEMATIC TRUS GUIDED BIOPSY AND MRI-FUSION BIOPSY IN THE DETECTION OF PROSTATE CANCER ¬– A PROSPECTIVE RANDOMIZED STUDY

Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) has been thecornerstone of prostate cancer (PCa) diagnosis. As an extension of mpMRI, anovel and potentially transformative technique, MRI/TRUS fusion-guided biopsy,has recently emerged as an option for a more precise prostate biopsy. Considering the technical complexity due toimplementation of robots, complex software, specific material and the longerintervention time as well as the expensive cost, MRI/TRUS fusion biopsy cannotbe recommended for a routine application in all biopsy-naïve men with elevatedPSA.We intend to study theadditional role of mpMRI followed by MRI/TRUS fusion biopsy for PCa detectionas compared to the systematic 12 core TRUS guided biopsy in biopsy-naïve menwith elevated PSA and/or clinical suspicion of cancer by designing aprospective randomized study. The null hypothesize for this study is that thereis no difference in terms of PCa detection between systematic 12 core TRUSguided biopsy and mpMRI followed by MRI-TRUS fusion in biopsy-naïve men withelevated PSA level of 4-11 ng/ml and/or clinical suspicion of cancer.