PSMA-Targeted Biopsy With Fusion Guidance for Detecting Clinically Significant Prostate Cancer in Men With Negative MRI-Feasibility and Diagnostic Performance of a Pilot Single-Center Prospective Study

Introduction: Contemporary prostate biopsy utilizes multiparametric magnetic resonance (MRI) guidance; however, it may fail to identify a non-negligible proportion of men with clinically significant (csPCa). The main objective of this study was to assess the feasibility and diagnostic performance of Prostate Specific Membrane Antigen-Target biopsy (PSMA-TB) to diagnose csPCa in men with negative MRI and high clinical risk of PCa. Patients and Methods: Open-label, single-center, nonrandomized, prospective study. Inclusion criteria: PSA density (PSAd) ≥0.2 ng/ml2 in men with PIRADS 1-2; PSA >10 ng/ml or abnormal digital rectal examination or strong familiar history for PCa or known genetic mutation. Each patients underwent PSMA-PET and transperineal fusion PSMA-TB ± systematic biopsy (SB). Results: Overall, 35 patients were enrolled; 23 (65.7%) men had positive PSMA-PET (PRIMARY score ≥3). Overall, 14 (40%) men had csPCA and 21 (60%) patients had any PCa at PSMA-TB+SB. Only 1 patient (8.3%) with negative PSMA-PET had csPCa (ISUP 3) at SB (92% Negative Predictive Value [NPV]). Fusion PSMA-TB alone detected csPCa in 12 out of 23 (52.2%) patients with positive PSMA-PET; fusion PSMA-TB with concomitant SB increased the detection of csPCa to 56.5% (added value of 4.3%). The sensitivity, specificity, Positive Predictive Value (PPV), NPV and AUC of PSMA-TB+SB were 93%, 57%, 59%, 92% and 0.75 for detection of csPCa and 91%, 79%, 86%, 95% and 0.84 for detection of any PCa, respectively. The main limitation of this study is its small sample size. Conclusions: Fusion PSMA-TB is technically feasible and may improve the detection of csPCa in patients with negative MRI.