MP09-03: Comparative Study of Significant Cancer Detection in Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Target Biopsy and Transperineal Template-Guided Systematic Biopsy: a 15-Center Prospective Study in Japan
Introduction: The objective of the present study was to evaluate the usefulness of magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate target biopsy in detecting biopsy-proven clinically significant prostate cancer (csPC) in a multicenter prospective study. Methods: Patients with serum prostate specific antigen (PSA) levels = 20 ng/m and suspected prostate cancer on multi-parametric MRI were enrolled from 2020 to 2021. For cancer-suspicious areas, each patient underwent a target biopsy and transperineal template-guided 12-core systematic biopsy. The csPC detection rates between target and systematic biopsies were compared. Results: The study included 400 patients (15 centers). The median age was 69 years (47-85), median PSA was 7.32 ng/mL (1.41-19.98), median prostate volume was 35 cc (7.4-131), median number of target biopsies per patient was 1 (1-4), and median biopsy time was 9 minutes (5-41). CsPC detection rates of patients’ target and systematic biopsies were 59.3% and 49%, respectively (P <0.0001). In the pathological findings of target and systematic biopsy cores, csPC detection (57% vs. 10.4%, P<0.0001), cancer core length (6 mm vs. 3 mm, P<0.0001), and cancer core percent (38% vs. 18%, P<0.0001) were significantly higher in target biopsies than in systematic biopsies. On multivariable logistic regression analysis to predict csPC, age (OR 1.054, P=0.002), PSA value (OR 1.097, P=0.033), PSA density (OR 2.068, P<0.0001), highest PI-RADS category (OR 5.105, P<0.0001), and location of the lesion with highest PI-RADS category (TZ vs. PZ) (OR 0.488, P=0.004) were significant risk factors for detecting csPC. On multivariable logistic regression analysis to predict csPC in patients with PI-RADS categories 2 and 3, PSAD was a significant risk factor for detecting csPC (OR 3.665, P<0.0001). Areas under the receiver operating characteristic curve (AUC) for PSAD was significantly greater than non-discrimination for the detection of csPC in patients with PI-RADS categories 2 and 3 (AUC 0.751, P<0.0001). Using cut-off value: 0.150 ng/mL/cc, sensitivity, specificity, positive predictive value, and negative predictive value for detecting csPC were 92.5%, 45.3%, 41.6%, and 93.5%, respectively. Conclusions: MRI-TRUS fusion image-guided target biopsy was superior to systematic biopsy in detecting patients with csPC. Using a cut-off value of PSAD would avoid unnecessary biopsies for regions with PI-RADS categories 2 and 3. SOURCE OF Funding: None.