Thompson et Yes Case series III-2 Australia n: 344 1.5T or 3.0T 2 radiologists TRUSGB + TP, TN, ≥ 4 al. 2016 - each with >1000 cog-MRI or FP, FN NR Age: Median 62.9 (IQR 55.9-67.1) Coil: NR – no key study prior prostate TRUS/MRI clinic ERC Prospective PSA: median 5.2 (IQR 3.7-7.1) mpMRIs FGB Contrast: Prior biopsy: NR gadolinum acid Wang et al. 2 radiologists TP, TN, Yes Case series III-2 China n: 586 1.5T TRUSGB ≥ 4 (2015) - key with 10 or 3 FP, FN Consecutive Tertiary Age: mean 70.0 (SD 8.3) Coil: PPAC + study years’ experience hospital ERC NR PSA: NR Contrast: Prior biopsy: NR Gadopenteic dimeglumine Zhao et al. Yes Case series III-2 China n: 372 3.0T 2 radiologists TRUSGB + TP, TN, ≥ 4 (2016) - key experienced in cog-MRI FP, FN NR Tertiary Age: mean 68.5 (SD 9.2) Coil: body coil study PI-RADS v2 hospital Retrospective PSA: mean 15.0 (SD 13.3) Contrast: NR Prior biopsy: NR Abd-Alazeez No Case series III-2 UK n: 54 1.5T or 3.0T 8 radiologists TRUSGB + TP, TN, ≥ 4 et al. 2014b - with 3-8 years’ cog-MRI FP, FN NR Tertiary Age: median 64 (range 39-75) Coil: PPAC per experience hospital Prospective PSA: median 10 (range 2-23) Contrast: hemisphere gadoterate Prior biopsy: 100% meglumine Busetto et al. No Case series III-2 Italy n: 163 3.0T NR TRUSGB + TP, TN, NA (2013) cog-MRI FP, FN Consecutive Tertiary Age: mean 66.4 (SD 5.3) Coil: PPAC + hospital ERC Prospective PSA: mean 6.8 (SD 1.6) Contrast: Prior biopsy: NR
Thompson et al. 2016 - key study Yes Case series NR Prospective III-2 Australia clinic n: 344 Age: Median 62.9 (IQR 55.9-67.1) PSA: median 5.2 (IQR 3.7-7.1) Prior biopsy: NR 1.5T or 3.0T Coil: NR – no ERC Contrast: gadolinum acid 2 radiologists each with >1000 prior prostate mpMRIs TRUSGB + cog-MRI or TRUS/MRI FGB TP, TN, FP, FN ≥ 4 Wang et al. (2015) - key study Yes Case series Consecutive NR III-2 China Tertiary hospital n: 586 Age: mean 70.0 (SD 8.3) PSA: NR Prior biopsy: NR 1.5T Coil: PPAC + ERC Contrast: Gadopenteic dimeglumine 2 radiologists with 10 or 3 years’ experience TRUSGB TP, TN, FP, FN ≥ 4 Zhao et al. (2016) - key study Yes Case series NR Retrospective III-2 China Tertiary hospital n: 372 Age: mean 68.5 (SD 9.2) PSA: mean 15.0 (SD 13.3) Prior biopsy: NR 3.0T Coil: body coil Contrast: NR 2 radiologists experienced in PI-RADS v2 TRUSGB + cog-MRI TP, TN, FP, FN ≥ 4 Abd-Alazeez et al. 2014b - per hemisphere No Case series NR Prospective III-2 UK Tertiary hospital n: 54 Age: median 64 (range 39-75) PSA: median 10 (range 2-23) Prior biopsy: 100% 1.5T or 3.0T Coil: PPAC Contrast: gadoterate meglumine 8 radiologists with 3-8 years’ experience TRUSGB + cog-MRI TP, TN, FP, FN ≥ 4 Busetto et al. (2013) No Case series Consecutive Prospective III-2 Italy Tertiary hospital n: 163 Age: mean 66.4 (SD 5.3) PSA: mean 6.8 (SD 1.6) Prior biopsy: NR 3.0T Coil: PPAC + ERC Contrast: NR TRUSGB + cog-MRI TP, TN, FP, FN NA
1397_Final_MSAC_Assessment_Report.docx