Role of 68Ga-PSMA-PET/CT for the detection of primary prostate cancer prior to biopsy: a prospective study

Introduction Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET-CT) is widely used as a staging tool for patients with prostate cancer (PCa). The objective of the study is to assess the diagnostic accuracy of 68Ga-PSMA-PET/CT for PCa, which may help us avoid unnecessary biopsies in patients with intermediate prostate-specific antigen (PSA) levels. Material and methods In this prospective study, 81 patients suspected of PCa, with either raised PSA between 4-20 ng/ml or abnormal digital rectal examination (DRE) findings were included. 68Ga-PSMA-PET/CT was performed for all patients followed by transrectal ultrasound (TRUS) guided prostate biopsy. SUVmax (maximum standardized uptake value) was measured and correlated with biopsy results. Results Out of 81 patients, 31 (38.3%) patients were found to have malignancy on biopsy. Median SUVmax of biopsy positive patients was 10.4 (IQR 6.5-16.1) and biopsy negative patients (n=50) was 3.5 (IQR 1-4.9), (p<0.001). At a cut-off of 6.15, 68GA-PSMA-PET/CT demonstrated sensitivity of 84%, specificity of 80%, positive predictive value of 72.2%, negative predictive value of 88.9% and accuracy of 81.5% with an AUC of 0.876 (95% CI: 0.799-0.953, p <0.001). Conclusions The 68Ga-PSMA-PET/CT helps to localize suspicious lesions and improving the detection of primary prostate cancer. Our findings indicate a significant correlation of SUVmax values with biopsy results. We were also able to determine a cut-off value of SUVmax below which prostate biopsy can be avoided in selected patients.