[New Prostate Cancer Guideline: Is Biopsy of PI-RADS 3 Lesions Meaningful? The Role of Multiparametric MRI-Ultrasound Fusion Biopsy in Detecting Clinically Significant Prostate Cancer].

MATERIALS AND

METHODS

The study included a total of 476 patients who underwent both a systematic 12-core punch biopsy and multiparametric MRI-guided fusion biopsies from at least one region of interest between January 2022 and December 2024. The primary endpoint was the detection of clinically significant prostate cancer (Gleason ≥3+4=7a). Lesions were classified according to their PI-RADS scores, and histological analysis of each lesion, obtained by multiparametric MRI fusion biopsy, was performed separately. Statistical analysis was performed using binomial logistic regression, and p-values <0.05 were considered statistically significant.

RESULTS

Targeted multiparametric MRI fusion biopsy, based on PI-RADS score, was a significant predictor of clinically relevant carcinoma (p<0.001). The number needed to test for the combined biopsy (systematic plus multiparametric MRI fusion) was 2.4, compared with 3.6 for systematic biopsy alone. The number needed to test for detecting clinically relevant carcinoma was 13.7 for PI-RADS-3 lesions, 3.8 for PI-RADS-4 lesions, and 1.7 for PI-RADS-5 lesions.

CONCLUSION

Lesions with PI-RADS scores of 4 and 5 should consistently undergo biopsy, whereas PI-RADS 3 lesions require individualised consideration to minimise overdiagnosis and unnecessary interventions. Our results confirm the recommendations of the current consultative version of the S3 guideline on prostate cancer (version 8.01, AWMF register number 043-022OL) and underline the clinical relevance of a risk-adapted diagnostic procedure.