Abstract

INTRODUCTION AND OBJECTIVE: The aim of our study was to evaluate the clinical management, follow up strategy and/or therapeutic approach in men with a negative multiparametric MRI (mpMRI)-TRUS targeted prostate biopsy (TB) with or without a contextual systematic 12-cores biopsy (SB) METHODS: Between 2015 and 2019, we submitted to TB patients with clinical suspicion of prostate cancer (PCa) and a suspicious area (index lesion) at mpMRI. Patients were stratified in three groups: those with negative TB and a negative contextual SB (Group 1); men with negative TB and a contextual positive SB for PCa (Group 2); patients with negative TB alone as SB was not performed in that same session (Group 3). In group 1 and 3 we evaluated the PSA trend during follow up and the results of further diagnostic procedures (including repeat mpMRI, TB and SB) in case of persistent suspicion of PCa in order to evaluate the clinical reliability of a negative TB. Finally, we reported the therapeutic approach adopted in patients in group 2 RESULTS: Overall, 535 patients underwent fusion TB and 230 (44%) were found to be negative at pathological examination. Non-statistical differences were observed between the three groups concerning age, PSA level, PSA density, suspected lesion’s size, location and PIRADs v2 score. Biopsy naïve patients were significantly lower in group 3 compared to group 1 and 2 (24.6% vs 64% and 51.1%, respectively; p<0.001). Median number of targeted cores per lesion taken was higher in patients in group 3 (6 vs 4, p<0.001). Overall, 14 patients (10.4%) repeated mpMRI within the follow-up interval, (8 negative cases, 4 PIRADS v2 score 3, and 2 PIRADS v2 score 4 lesions detected). During follow up, 10 patients were submitted to re-biopsy (2 SB, 5 TB and 3 TB with contextual SB): 3 cases resulted positive for PCa Gleason score 3+3. Figure 1 resumes our therapeutic approach in patients with a negative TB and a contextual positive SB (Group 3): overall, 39.3% of patients were enrolled under AS protocol, 54.3% were submitted to active radical treatment (radical prostatectomy in 44.6%) and 6.4% of patients were scheduled for ADT CONCLUSIONS: Our study shows that a negative TB (with or without a contextual negative SB), can be clinically reliable for low risk to miss PCa diagnosis. SB continues to play a key role in PCa detection, as almost 55% of patients with a negative TB and a positive SB needed radical treatmentSource of Funding: no

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