BACKGROUND
To evaluate performance of magnetic resonance (MR)-ultrasound guided fusion biopsy in diagnosing clinically significant prostate cancer (csCaP).
METHODS
1042 men underwent multi-parametric MRI (mpMRI) and fusion biopsy consecutively in a prospective trial (2009 – 2014). An expert reader graded mpMRI regions of interest (ROI) 1–5 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. Primary endpoint was detection of clinically significant CaP (i.e., Gleason score ≥ 7).
RESULTS
Among 825 men with ≥ 1 suspicious ROI of grade 3 or higher, 289 (35%) had csCaP. Powerful predictors of csCaP were ROI grade (grade 5 vs 3, OR 6.5, p<0.01) and prostate-specific antigen density (each increase of 0.05 ng/mL/cc, OR 1.4, p<0.01). Combining systematic and targeted biopsies detected more csCaP (n=289) than targeting (n=229) or systematic biopsy alone (n=199). Among patients with no suspicious ROI, 35 (16%) had csCaP on systematic biopsy.
CONCLUSION
In this prospective trial, MR-ultrasound fusion biopsy allowed detection of csCaP with a direct relationship with ROI grade and PSA 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. Advantages of this new biopsy method are apparent, but issues of cost, training, and reliability await resolution prior to widespread adoption.