Purpose: This is a prospective pair cohort validating study to assess the clinical performance of a 3D ultrasound-guided imaging device (HistoScanning) to detect clinically significant prostate cancer.
Methods: Data was collected prospectively from April 2016 to September 2018 from 200 patients who had their serum PSA levels rising for at least 4 months after previous negative trans rectal ultrasound-guided TRUS biopsy in a single center. All eligible men underwent prostate HistoScanning (PHS) and transperineal template prostate mapping biopsy as our reference standard and additional single targeted biopsy, when PHS device tested positive with a suspicious lesion of ≥0.5 cm3. Our primary goal was to obtain the results of PHS ability to detect clinically significant prostate cancer. Our secondary goal was to acquire data on PHS targeted biopsies.
Results: In our study 200 men were enrolled and their mean age was 62 ±5.9 years. The mean number of previous biopsies was 1.51±0.65. The mean volume for PHS index lesion in any one prostate was 1.56 ±2.01 ml. Clinically significant prostate cancer (csPCa) was detected in 41 (20.5%) patients on biopsy. Sensitivity of PHS for detecting csPCa was 61.9% (95% CI 45.64-76.43) with specificity 27.85% (95% CI 21-35.53). Positive predictive value (PPV) and negative predictive value (NPV) for PHS were 18.57% (95% CI 15-22.76) and 73.33% (95% CI 63.45-81.33), respectively. Overall accuracy calculated by AUROC curve was 0.39 (95% CI 0.3-0.47).
Conclusion: PHS performance results of our study on detecting clinically significant prostate cancer were insufficient to include this ultrasound-guided diagnostic test as standard diagnostic tool.