De No Case series III-2 Belgium n: 830 1.5T 1 uroradiologist TRUSGB TP, TN, NA Visschere et with >10 years’ FP, FN Consecutive Tertiary Age: mean 64.8 (range 40-83) Coil: PPAC + al. (2016) experience hospital ERC Retrospective PSA: median 8.34 (range 0.41-200) Contrast: NR Prior biopsy: 35.8% Ferda et al. No Case series III-2 Czech n: 191 3.0T NR TRUSGB TP, TN, NA (2013) Republic FP, FN NR Age: (range 47-79) Coil: PPAC Tertiary Prospective PSA: (range 4.2-123) Contrast: hospital gadobenate Prior biopsy: NR dimeglumine Girometti et 2 experienced TRUSGB + TP, TN, No Case series III-2 Italy n: 26 3.0T NA al. (2012) radiologists cog-MRI FP, FN Consecutive Tertiary Age: median 64 (range 51-74) Coil: perineum hospital loop coil Prospective PSA: median 5.95 (range 2.52-9.74) Contrast: gadobenate dimeglumine Haffner et al. 2 senior TRUSGB + TP, TN, No Case series III-2 France n: 555 1.5T ≥ 3 (2011) radiologists cog-MRI FP, FN Consecutive Tertiary Age: median 64 (range 47-83)] Coil: PPAC hospital Retrospective PSA: median 6.75 (range 0.18-100) Contrast: Prior biopsy: 0% contrast Hauth et al. No Case series III-2 Germany n: 94 1.5T 2 radiologists TRUSGB + TP, TN, ≥ 3 (2015) with > 3 years’ cog-MRI FP, FN Consecutive Tertiary Age: mean 63 (range 43-83) Coil: PPAC experience hospital NR PSA: mean 9 (range 3-31) Contrast: gadobutrol Prior biopsy: NR
De Visschere et al. (2016) No Case series Consecutive Retrospective III-2 Belgium Tertiary hospital n: 830 Age: mean 64.8 (range 40-83) PSA: median 8.34 (range 0.41-200) Prior biopsy: 35.8% 1.5T Coil: PPAC + ERC Contrast: NR 1 uroradiologist with >10 years’ experience TRUSGB TP, TN, FP, FN NA Ferda et al. (2013) No Case series NR Prospective III-2 Czech Republic Tertiary hospital n: 191 Age: (range 47-79) PSA: (range 4.2-123) Prior biopsy: NR 3.0T Coil: PPAC Contrast: gadobenate dimeglumine NR TRUSGB TP, TN, FP, FN NA Girometti et al. (2012) No Case series Consecutive Prospective III-2 Italy Tertiary hospital n: 26 Age: median 64 (range 51-74) PSA: median 5.95 (range 2.52-9.74) 3.0T Coil: perineum loop coil Contrast: gadobenate dimeglumine 2 experienced radiologists TRUSGB + cog-MRI TP, TN, FP, FN NA Haffner et al. (2011) No Case series Consecutive Retrospective III-2 France Tertiary hospital n: 555 Age: median 64 (range 47-83)] PSA: median 6.75 (range 0.18-100) Prior biopsy: 0% 1.5T Coil: PPAC Contrast: contrast 2 senior radiologists TRUSGB + cog-MRI TP, TN, FP, FN ≥ 3 Hauth et al. (2015) No Case series Consecutive NR III-2 Germany Tertiary hospital n: 94 Age: mean 63 (range 43-83) PSA: mean 9 (range 3-31) Prior biopsy: NR 1.5T Coil: PPAC Contrast: gadobutrol 2 radiologists with > 3 years’ experience TRUSGB + cog-MRI TP, TN, FP, FN ≥ 3
1397_Final_MSAC_Assessment_Report.docx