Objective: Transrectal ultrasound-guided prostate biopsy (TRUSPBx) is the recommended method for the histopathologic confirmation of prostate cancer. However, the overall cancer detection rate is low; hence, patients are potentially exposed to multiple biopsies and their attendant morbidity. Multiparametric MRI of the prostate followed by MRI-Ultrasound fusion-guided prostate biopsy (FBx) is an emerging diagnostic pathway that has been established and recommended in men with a persistently elevated PSA despite a previous negative biopsy. However, evidence regarding its value in the biopsy-naïve setting is scarce. The objective is to compare the diagnostic accuracy of MRI fusion-guided prostate biopsy against TRUSPBx in biopsy-naïve men.
Methods: This is a retrospective cohort study involving biopsy-naïve men with a PSA of 3 to 20 ng/ml. Primary outcomes of the study include overall cancer detection rate (CDR) and detection of clinically-significant prostate cancer (csPCa). Subgroup analyses were performed based on PSA level and prostate volume. Independent t-test, Mann Whitney U test and Chi square test were used in the statistical analysis.
Results: A total of 185 biopsy-naïve men with a PSA level of 3 – 20 ng/mL were included in the study. Median pre-biopsy PSA level was 7.07 ng/mL (5.06 – 11.0) and 9.02 ng/mL (5.8 – 13.8) in the FBx arm and TRUS-guided biopsy arm, respectively. Ninety-nine (n=99; 53%) underwent MP-MRI of the prostate followed by MRI fusion-guided prostate biopsy and eighty-six (n=86; 46%) underwent the standard TRUS-guided prostate biopsy. Compared to TRUSPBx, FBx significantly detected more prostate cancer (CDR: 68% vs 30%, p<0.0001) and csPCa (46% vs 22%, p=0.001). The diagnostic yield of FBx was distinctly superior in the subgroup of men with a PSA of 4 – 10 ng/mL (CDR: 64% vs 7%, p<0.0001; csPCa: 43% vs 2%, p<0.0001) and a prostate volume of <40grams (CDR: 82% vs 36%, p<0.0001; csPCa: 53% vs 21%, p=0.006).
Conclusion: Compared to the current standard, the diagnostic yield of MRI fusion-guided prostate biopsy is significantly better in biopsy-naïve men. FBx detected more men with prostate cancer, with a higher proportion of men having clinically-significant disease. This advantage is strongly evident in men with a PSA level of 4 – 10 ng/mL and an average prostate volume of 40 grams. Hence, Multiparametric MRI of the prostate followed by MRI fusion-guided prostate biopsy is an effective first-line diagnostic modality for prostate cancer in men presenting with elevated PSA levels.
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