Prostate cancer detection by targeted prostate biopsy using the 3D Navigo system: a prospective study

Purpose The 3D Navigo™ system is a magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) fusion device for prostate targeted biopsies (TB). Our aim was to evaluate the clinically significant prostate cancer (CSC) detection rate of TB using the 3D Navigo™ system. Methods Patients who underwent TB with the 3D Navigo™ system in our center between June 2014 and May 2018 were prospectively included, excluding those who have previously received treatment for prostate cancer. A 3-Tesla MRI imaging was performed before biopsies; findings were reported according to the Prostate Imaging Reporting and Data System version 2 (PIRADS). CSC was defined by an ISUP score ≥ 2. Results 304 patients underwent TB. Median age was 66 years (51–84). Median PSA was 7.75 ng/ml (0.6–70.0). Median prostate volume was 45.0 ml (15.9–221.7). PCa and CSC were found in 70.4% (214/304) and 47.7% (145/304) of the patients, respectively. The proportion of patients diagnosed with CSC among those with PCa was 67.8% (145/214). There was a significant risk of having a CSC in case of PIRADS score ≥ 4 and 5 (OR 5.0, 95% CI [2.7–9.2], P < 0.001; OR 3.2, 95% CI [1.8–5.5], P < 0.001). PIRADS score was an independent risk factor of having a CSC (OR 4.19, 95% CI [2.49–7.05], P < 0.001). There was no significant difference between pathological outcomes of TB and RP in paired analysis ( P = 0.892). There was a correlation between TB and RP specimens for PCa detection ( r = 0.60, P < 0.001). Conclusion Detecting CSC with MRI-TRUS fusion targeted biopsies using the 3D Navigo™ system is feasible and safe. We found a positive correlation between TB and RP for ISUP scores.