Frank-Jan H Drost1, Daniel Osses1, Daan Nieboer2, Chris H Bangma3, Ewout W Steyerberg4, Monique J Roobol3, Ivo G Schoots5. 1. Department of Radiology & Nuclear Medicine, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands; Department of Urology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. 2. Department of Urology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands; Department of Public Health, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. 3. Department of Urology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. 4. Department of Public Health, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. 5. Department of Radiology & Nuclear Medicine, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: i.schoots@erasmusmc.nl.
Abstract
CONTEXT: Magnetic resonance imaging (MRI), with or without MRI-targeted biopsy (MRI pathway), is an alternative test to systematic transrectal ultrasonography-guided biopsy in men suspected of having prostate cancer. At present, evidence on which test to use is insufficient to inform detailed evidence-based decision making. OBJECTIVE: To determine the diagnostic accuracy of the index tests MRI only, MRI-targeted biopsy, MRI pathway, and systematic biopsy, as compared with template-guided biopsy (reference standard), in detecting clinically significant prostate cancer, defined as International Society of Urological Pathology grade 2 or higher, in biopsy-naive men or those with a prior-negative biopsy (or mix of both). EVIDENCE ACQUISITION: We systematically searched the literature and considered for inclusion any cross-sectional study if it investigated (1) one or more index tests verified by the reference standard, and (2) paired testing of the MRI pathway with systematic biopsy. Quality and certainty of evidence were assessed by the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Grading of Recommendations Assessment, Development and Evaluation, respectively. EVIDENCE SYNTHESIS: Accuracy analyses: Using a baseline cancer prevalence of 30%, MRI pathway (sensitivity 0.72 [95% confidence interval {CI}: 0.60-0.82]; specificity 0.96 [0.94-0.98]; eight studies) may result in 216 (180-246) true positives, 28 (14-42) false positives, 672 (658-686) true negatives, and 84 (54-120) false negatives per 1000 men. Systematic biopsy (sensitivity 0.63 [0.19-0.93]; specificity 1.00 [0.91-1.00]; four studies) may result in 189 (57-279) true positives, 0 (0-63) false positives, 700 (637-700) true negatives, and 111 (21-243) false negatives per 1000 men. Agreement analyses: With a direct comparison of the MRI pathway with systematic biopsy concerning significant disease, we found pooled detection ratios of 1.05 (95% CI: 0.95-1.16; 20 studies) in biopsy-naive men and 1.44 (1.19-1.75; 10 studies) in men with a prior-negative biopsy. Concerning insignificant disease, we found detection ratios of 0.63 (95% CI: 0.54-0.74), and 0.62 (95% CI: 0.44-0.88), respectively. CONCLUSIONS: MRI pathway had the most favourable outcome in significant and insignificant prostate cancer detection compared with systematic biopsy. The certainty in our findings was reduced by study limitations. PATIENT SUMMARY: We reviewed recent advances in prostate biopsy by magnetic resonance imaging (MRI) guidance and targeting for prostate cancer detection in comparison with standard diagnosis by systematic biopsies. The findings of this Cochrane review suggest that MRI pathway is better than systematic biopsies in making a correct diagnosis of clinically important prostate cancer and reducing redundant biopsies and the detection of unimportant cancers substantially. However, MRI pathway still misses some men with important prostate cancer. Therefore, further research in this area is important.
CONTEXT: Magnetic resonance imaging (MRI), with or without MRI-targeted biopsy (MRI pathway), is an alternative test to systematic transrectal ultrasonography-guided biopsy in men suspected of having prostate cancer. At present, evidence on which test to use is insufficient to inform detailed evidence-based decision making. OBJECTIVE: To determine the diagnostic accuracy of the index tests MRI only, MRI-targeted biopsy, MRI pathway, and systematic biopsy, as compared with template-guided biopsy (reference standard), in detecting clinically significant prostate cancer, defined as International Society of Urological Pathology grade 2 or higher, in biopsy-naive men or those with a prior-negative biopsy (or mix of both). EVIDENCE ACQUISITION: We systematically searched the literature and considered for inclusion any cross-sectional study if it investigated (1) one or more index tests verified by the reference standard, and (2) paired testing of the MRI pathway with systematic biopsy. Quality and certainty of evidence were assessed by the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Grading of Recommendations Assessment, Development and Evaluation, respectively. EVIDENCE SYNTHESIS: Accuracy analyses: Using a baseline cancer prevalence of 30%, MRI pathway (sensitivity 0.72 [95% confidence interval {CI}: 0.60-0.82]; specificity 0.96 [0.94-0.98]; eight studies) may result in 216 (180-246) true positives, 28 (14-42) false positives, 672 (658-686) true negatives, and 84 (54-120) false negatives per 1000 men. Systematic biopsy (sensitivity 0.63 [0.19-0.93]; specificity 1.00 [0.91-1.00]; four studies) may result in 189 (57-279) true positives, 0 (0-63) false positives, 700 (637-700) true negatives, and 111 (21-243) false negatives per 1000 men. Agreement analyses: With a direct comparison of the MRI pathway with systematic biopsy concerning significant disease, we found pooled detection ratios of 1.05 (95% CI: 0.95-1.16; 20 studies) in biopsy-naive men and 1.44 (1.19-1.75; 10 studies) in men with a prior-negative biopsy. Concerning insignificant disease, we found detection ratios of 0.63 (95% CI: 0.54-0.74), and 0.62 (95% CI: 0.44-0.88), respectively. CONCLUSIONS: MRI pathway had the most favourable outcome in significant and insignificant prostate cancer detection compared with systematic biopsy. The certainty in our findings was reduced by study limitations. PATIENT SUMMARY: We reviewed recent advances in prostate biopsy by magnetic resonance imaging (MRI) guidance and targeting for prostate cancer detection in comparison with standard diagnosis by systematic biopsies. The findings of this Cochrane review suggest that MRI pathway is better than systematic biopsies in making a correct diagnosis of clinically important prostate cancer and reducing redundant biopsies and the detection of unimportant cancers substantially. However, MRI pathway still misses some men with important prostate cancer. Therefore, further research in this area is important.
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