68Ga-PSMA PET/CT Combined with PET/Ultrasound-Guided Prostate Biopsy Can Diagnose Clinically Significant Prostate Cancer in Men with Previous Negative Biopsy Results

The purpose of this study was to investigate the feasibility and diagnostic efficacy of ⁶⁸Ga-prostate-specific membrane antigen (PSMA) PET/CT combined with PET/ultrasound-guided biopsy in the diagnosis of prostate cancer (PCa). Methods: In total, 31 patients with a previously negative prostate biopsy but persistent elevated serum prostate-specific antigen (PSA) were imaged with a ⁶⁸Ga-PSMA PET/CT ligand before undergoing repeat prostate biopsy. On the basis of the proposed Prostate Cancer Molecular Imaging Standardized Evaluation criteria, ⁶⁸Ga-PSMA PET/CT results were interpreted as negative (molecular-imaging-for-PSMA expression score [miPSMA-ES] of 0–1) or positive (miPSMA-ES of 2–3). All patients underwent standard template systematic biopsy with up to 4 additional PET/ultrasound-guided biopsy cores. The sensitivity, specificity, positive and negative predictive values, and accuracy of ⁶⁸Ga-PSMA PET/CT were determined. In addition, the correlation between the miPSMA-ES and the detection rate of PCa was also analyzed. Univariate logistic regression models were established using ⁶⁸Ga-PSMA PET/CT semiquantitative analysis parameters to predict the outcome of repeat prostate biopsy. Results: The median age of patients was 65 y (range, 53–81 y), and the median PSA level was 18.0 ng/mL (range, 5.48–49.77 ng/mL). PCa was detected in 15 of 31 patients (48.4%), and 12 of 31 patients (38.7%) had clinically significant PCa (csPCa). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ⁶⁸Ga-PSMA PET/CT in the diagnosis of csPCa were 100.0%, 68.4%, 66.7%, 100.0%, and 80.6%, respectively. The detection rate of PCa increased with the increase in miPSMA-ES. The detection rates of csPCa in the miPSMA-ES 0–1, 2, and 3 groups were 0%, 54.5%, and 85.7%, respectively. Semiquantitative analysis of ⁶⁸Ga-PSMA PET/CT images showed that predictive models based on the SUV_max of prostate lesion, tumor–to–normal-prostate background SUV_max, and tumor–to–normal-liver background SUV_max could effectively predict csPCa; area under the curves were 0.930, 0.877, and 0.956, respectively. Conclusion: This study preliminarily confirmed that ⁶⁸Ga-PSMA PET/CT imaging, combined with PET/ultrasound-guided prostate biopsy, can effectively detect csPCa. Prebiopsy ⁶⁸Ga-PSMA PET/CT had predictive value for csPCa in the studied patient population.