For patients presenting with a PI-RADS 5 lesion on MRI, there is a high likelihood of clinically significant prostate cancer (csPCa). However, negative biopsy results do occur in real-life settings, posing a follow-up challenge due to limited guidelines. This study aimed to provide long-term insights on outcomes for patients with a PI-RADS 5 lesion and a subsequent negative biopsy. Data from 876 patients who underwent MRI-guided prostate biopsies were reviewed, focusing on cases with clinical suspicion of prostate cancer (PCa). Among these, 109 patients had PI-RADS 5 lesions, with 32 (29.4%) showing negative biopsy results. The average patient age was 67, with a median PSA level of 7.9 ng/mL and a median prostate volume of 67 mL. Over a median follow-up of 50.5 months, PSA levels decreased in 38% of these patients, remained stable in 34%, and increased in 28%. Additional MRIs were performed on 50% of these patients, revealing PI-RADS 3 or higher lesions in 31%. Four patients were eventually diagnosed with PCa, with three confirmed as csPCa.
MRI demonstrated high sensitivity (100%) in identifying suspicious lesions for this population, though its Positive Predictive Value (PPV) was relatively low (30%). PSA density emerged as a critical predictor, with a threshold of >0.20 showing 100% sensitivity, 93% specificity, and a 60% PPV for detecting csPCa. These findings suggest that, although the risk of csPCa diagnosis remains low over time for patients with initial negative biopsies, PSA density may serve as a valuable tool alongside MRI in monitoring disease progression. The study underscores the need for larger follow-up studies to validate these predictors in broader populations.
