Prostate cancer: diagnostic performance of real-time shear-wave elastography.

Abstract

To prospectively evaluate the performance of real-time ultrasonographic (US) shear-wave elastography (SWE) in the diagnosis of peripheral zone prostate cancer in patients with high and/or increasing prostate-specific antigen levels and/or abnormal digital rectal examination results. After signing an informed consent form, men referred for transrectal prostate biopsy were enrolled in this prospective HIPAA-compliant two-center study, which was conducted with institutional review board approval. Transrectal US SWE of the prostate was performed after a conventional transrectal US examination and immediately before US-guided 12-core sextant biopsy. For each sextant, the maximum SWE value was measured and matched to the pathologic results of that sextant biopsy. The diagnostic performance of SWE was assessed at both patient and sextant levels. The elasticity value maximizing the Youden index was used to derive sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The elasticity values were matched to pathologic results for a total of 1040 peripheral zone sextants in 184 men. One hundred twenty-nine positive biopsy findings (size, ≥3 mm; Gleason score, ≥6) were identified in 68 patients. The sextant-level sensitivity, specificity, PPV, NPV, and area under the receiver operating characteristic curve for SWE with a cutoff of 35 kPa for differentiating benign from malignant lesions were 96% (95% confidence interval [CI]: 95%, 97%), 85% (95% CI: 83%, 87%), 48% (95% CI: 46%, 50%), 99% (95% CI: 98%, 100%), and 95% (95% CI: 93%, 97%), respectively. Use of a 35-kPa threshold at SWE may provide additional information for the detection and biopsy guidance of prostate cancer, enabling a substantial reduction in the number of biopsies while ensuring that few peripheral zone adenocarcinomas are missed.