Jambor et al. Yes Case series III-2 Finland n: 55 3.0T NR TRUSGB + TP, TN, ≥ 4 (2014) - key cog-MRI FP, FN NR Tertiary Age: median 66 (range 47-76) Coil: body coil study hospital Retrospective PSA: median 7.4 (range 4-14) Contrast: Dotaren or Prior biopsy: 0% Gadovist Lista et al. Yes Case series III-2 Spain n: 150 1.5T NR TRUSGB TP, TN, ≥ 4 2015 - key FP, FN NR Tertiary Age: mean 66.2 (SD 5) Coil: study hospital PPAC+ERC Prospective PSA mean 11.3 (SD 9.6) Contrast: NR Prior biopsy: 100% Pokorny et 3 radiologists TP, TN, Yes Case series II Australia n: 226 3.0T TRUSGB ≥ 4 al. (2014) - with: 1 year, 1 FP, FN Consecutive Age: Median 63 (IQR 57-68) Coil: NR – no key study year or 19 years’ tertiary ERC Prospective PSA: median 5.3 (IQR 4.1-6.6) experience. Hospital Contrast: NR Prior biopsy: NR Dedicated training of readers Thompson et Yes Case series III-2 Australia n: 150 1.5T or 3.0T 2 radiologists TRUSGB + TP, TN, ≥ 4 al. (2014) - each with >1000 cog-MRI FP, FN Consecutive Age: Median 62.4 (IQR 55-66.4) Coil: NR – no key study prior prostate clinic ERC Prospective PSA: median 5.6 (IQR 4.5-7.5) mpMRIs Contrast: Prior biopsy: NR gadolinum acid
Jambor et al. (2014) - key study Yes Case series NR Retrospective III-2 Finland Tertiary hospital n: 55 Age: median 66 (range 47-76) PSA: median 7.4 (range 4-14) Prior biopsy: 0% 3.0T Coil: body coil Contrast: Dotaren or Gadovist NR TRUSGB + cog-MRI TP, TN, FP, FN ≥ 4 Lista et al. 2015 - key study Yes Case series NR Prospective III-2 Spain Tertiary hospital n: 150 Age: mean 66.2 (SD 5) PSA mean 11.3 (SD 9.6) Prior biopsy: 100% 1.5T Coil: PPAC+ERC Contrast: NR NR TRUSGB TP, TN, FP, FN ≥ 4 Pokorny et al. (2014) - key study Yes Case series Consecutive Prospective II Australia Hospital n: 226 Age: Median 63 (IQR 57-68) PSA: median 5.3 (IQR 4.1-6.6) Prior biopsy: NR 3.0T Coil: NR – no ERC Contrast: NR 3 radiologists with: 1 year, 1 year or 19 years’ experience. Dedicated training of readers TRUSGB TP, TN, FP, FN ≥ 4 Thompson et al. (2014) - key study Yes Case series Consecutive Prospective III-2 Australia clinic n: 150 Age: Median 62.4 (IQR 55-66.4) PSA: median 5.6 (IQR 4.5-7.5) 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 TP, TN, FP, FN ≥ 4 tertiary
1397_Final_MSAC_Assessment_Report.docx