Abstract
BACKGROUND: The current study was conducted to evaluate the performance of magnetic resonance (MR)-ultrasound-guided fusion biopsy in diagnosing clinically significant prostate cancer (csCaP). METHODS: A total of 1042 men underwent multiparametric MR imaging (mpMRI) and fusion biopsy consecutively in a prospective trial (2009-2014). An expert reader graded mpMRI regions of interest (ROIs) as 1 to 5 using published protocols. The fusion biopsy device was used to obtain targeted cores from ROIs (when present) followed by a fusion image-guided, 12-core systematic biopsy in all men, even if no suspicious ROI was noted. The primary endpoint of the study was the detection of csCaP (ie, Gleason score ≥ 7). RESULTS: Among 825 men with ≥ 1 suspicious ROI of ≥ grade 3, 289 (35%) were found to have csCaP. Powerful predictors of csCaP were ROI grade (grade 5 vs grade 3: odds ratio, 6.5 [P<.01]) and prostate-specific antigen density (each increase of 0.05 ng/mL/cc: odds ratio, 1.4 [P<.01]). Combining systematic and targeted biopsies resulted in the detection of more patients with csCaP (289 patients) than targeting (229 patients) or systematic (199 patients) biopsy alone. Among patients with no suspicious ROI, 35 (16%) were found to have csCaP on systematic biopsy. CONCLUSIONS: In this prospective trial, MR-ultrasound fusion biopsy allowed for the detection of csCaP, with a direct relationship noted with ROI grade and prostate-specific antigen density. The combination of targeted and systematic biopsy detected more csCaP than either modality alone; systematic biopsies revealed csCaP in 16% of men with no suspicious MRI target. The advantages of this new biopsy method are apparent, but issues of cost, training, and reliability await resolution before its widespread adoption.