PURPOSE: To evaluate detection of clinically significant prostate cancer (csPCa) using MRI-targeted biopsies, and compare visual-estimation to image-fusion targeting, in patients requiring repeat prostate biopsies. MATERIALS AND METHODS: Prospective, ethics-committee approved, registered PICTURE trial enrolling 249 consecutive patients (11th/January/2012-29th/January/2014). Men underwent an mpMRI and were blinded to its results. All underwent transperineal template prostate mapping (TTPM) biopsies. In 200 with a lesion, this was preceded by visual-estimation and image-fusion targeted biopsies. For the primary endpoint, csPCa was defined as Gleason >/=4+3 and/or any grade of cancer length >/=6mm. Other definitions of csPCa were also evaluated. RESULTS: Mean (SD) age was 62.6 (7) years, median (IQR) PSA 7.17ng/ml (5.25, 10.09), mean primary lesion size 0.37cc (SD1.52), with mean 4.3 (SD2.3) targeted cores per lesion (visual-estimation and image-fusion combined) and mean 48.7 (SD12.3) TTPM-biopsy cores. TTPM-biopsies detected 97 (48.5%) cases of csPCa and 85 (42.5%) insignificant cancers. Overall, mpMRI-targeted biopsies detected 81 (40.5%) csPCa and 63 (31.5%) insignificant cancers. Eighteen (9%) with csPCa on MRI-targeted biopsies were benign or clinically insignificant on TTPM-biopsy. Thirty-four (17%) had csPCa detected on TTPM-biopsy but not on MRI-targeted biopsies; approximately half of these were present in non-targeted areas. csPCa was found with visual-estimation and image-fusion in 53/169 (31.3%) and 48/169 (28.4%) (McNemar's test, p=0.5322). Visual-estimation missed 23 (13.6%) csPCa detected by image-fusion; image-fusion missed 18 (10.8%) csPCa that visual-estimation detected. CONCLUSIONS: MRI-targeted biopsies are accurate at detection of csPCa and reducing over-diagnosis of insignificant cancers. To maximise detection both visual-estimation and image-fusion targeted biopsies are required
