Mp46-09 Image-Based Diagnosis of Prostate Cancer (Dimcapro Study): Randomized Prospective Study in Biopsy-Naïve Population Comparing Diagnosis Standard Pathway vs an Image-Guided Approach Using Mpmri and Target Biopsy

Abstract

previous negative biopsy, and continued suspicion of prostate cancer, we are seeing an increased utilization on mpMRI in biopsy naive men. We performed a systematic review and meta-analysis of prospective studies looking at the performance of mpMRI on prostate cancer detection in men who had never undergone a previous biopsy of the prostate.METHODS: We searched the Pubmed, Embase and Cochrane databases for studies assessing the performance of mpMRI on prostate cancer detection at biopsy. Studies were included if they were prospective, included only patients with no previous prostate biopsy, and reported biopsy outcomes for all patients including those with a negative mpMRI. Each mpMRI was classified as either positive or negative for suspicion of prostate cancer. We used standard methods recommended for meta-analyses of diagnostic test evaluation and reported the pooled sensitivity, specificity, and positive and negative likelihood ratios for mpMRI on the detection of any and clinically significant prostate cancer (csPCa). csPCa was defined according to the definition used in each paper, which was usually any Gleason 7 or a minimum length of Gleason 6. Summary receiver operating characteristic (SROC) curves were used to assess the performance of mpMRI on prostate cancer detection.RESULTS: Ten studies met the inclusion criteria comprising 2,194 patients. If a biopsy was only to be performed in men with a positive mpMRI, then 7.4 to 58.5% of biopsies could have been avoided, with only 2.3-36% of cancers and 6.3-30.8% of csPCa being missed. Of the ten studies we found, nine had data available for a metaanalysis of any prostate cancer and five had data available for a metaanalysis of csPCa. For any prostate cancer, the pooled sensitivity and specificity were 0.83 (95% CI, 0.75-0.88), and 0.71 (0.46-87), while the positive and negative likelihood ratio were 2.9 (1.3-6.0) and 0.23 (0.15-0.35), respectively. The AUC for any prostate cancer detection was 0.87 and the diagnostic odds ratio (DOR) was 12.3 (4.3-34.7). For csPCa, the pooled sensitivity and specificity was 0.83 (0.75-0.88) and 0.58 (0.46e0.69), while, the positive and negative likelihood ratio was 2 (CI, 1.5-2.5), and 0.28 (0.19-0.39), respectively. The AUC for csPCa detection was 0.66 and the DOR was 7.1 (4.5-11.1).CONCLUSIONS: A meta-analysis of prospective studies in men with no previous biopsy of the prostate confirms that mpMRI of the prostate accurately detects prostate cancer and can help avoid unnecessary biopsies.

Comparison of Multiparametric Magnetic Resonance Imaging and Targeted Biopsy With Systematic Biopsy Alone for the Diagnosis of Prostate Cancer

“…The literature searches identified 1742 records, of which 7 RCTs fulfilled the inclusion criteria (Figure 2): 6 original investigations 25,26,27,28,29,30 and 1 conference abstract 31 including 2582 patients in total. In 5 RCTs, 25,26,27,28,31 the clinical suspicion of PCa was based on elevated PSA levels, abnormal digital rectal examination findings, or both. In 2 RCTs, 29,30 patients with abnormal digital rectal examination findings were excluded.…”

“…In all but 1 RCT, 26 individuals with negative prebiopsy MRI findings proceeded to undergo a systematic biopsy, with this procedure being identical to that performed in the systematic biopsy alone group because there was no visible MRI lesion to be sampled by a targeted approach. In 2 RCTs, 26,29 individuals with positive MRI findings underwent a targeted procedure alone (MRI plus targeted biopsy pathway), whereas in the other RCTs, 25,27,28,30,31 individuals with positive MRI findings underwent a combined procedure incorporating both targeted and systematic cores (Figure 3). For 3 of the MRI plus targeted and systematic biopsy RCTs, 25,28,30 it was possible to extract sufficient data regarding the content of the targeted cores.…”

“…Two RCTs 25,29 used a 1.5-T MRI scanner, 4 RCTs 27,28,30,31 used a 3.0-T MRI scanner, and 1 RCT 25 included data from both 1.5- and 3.0-T MRI scanners. Three RCTs 26,27,29 used a phased-array coil with or without an endorectal coil, 1 RCT 30 used body and spine matrix surface coils, 1 RCT 31 used a transrectal coil, 1 RCT 25 did not use a coil, and 1 RCT 28 did not report whether a coil was used. One RCT 25 used biparametric MRI, whereas the other RCTs used mpMRI.…”

“…One RCT 25 used biparametric MRI, whereas the other RCTs used mpMRI. Different definitions were used to define a positive MRI, including a Prostate Imaging Reporting and Data System score of 3 or higher, 25,26,29 Prostate Imaging Reporting and Data System score of 4 or higher, 31 or any lesion detected at MRI without the use of a standardized reporting system (eTable 2 in the Supplement). 27,28,30 The images were interpreted by at least 1 experienced radiologist 25,26,31 or were assessed in consensus by 2 radiologists 27,28,30 or 3 radiologists 29 (eTable 1 in the Supplement).…”

“…The individuals randomized to the systematic biopsy alone group underwent a standard TRUS-guided prostate biopsy systematically sampling the peripheral zones of the prostate gland (eTable 1 in the Supplement) with 12 cores, 25,29 14 cores, 27 or 10 to 12 cores 26,28,30 taken during the procedure. Most trials used only the transrectal approach to perform targeted prostate biopsies; 25,27,28,30,31 however, 2 trials 26,29 used either the transrectal or transperineal approach depending on local expertise or the anatomic location of the radiological lesion. Transperineal approaches were used only in the MRI group of these studies, whereas in the systematic biopsy alone group, all biopsies were performed using the transrectal approach.…”