Magnetic Resonance Imaging for Pre-Treatment Local Staging of Prostate Cancer

screen (n=270)Records excluded based on abstract(n=170)a n=87, not relevant (e.g. topic, technical MRI study,laboratory study, active surveillance, screening, PSAtesting, technical aspects of biopsy); n=61, narrativereview; n=15, case reports or letters; n=5,intervention (e.g. other technologies or treatments,drugs, pre-biopsy MRIs); n=2, other prostate cancertopics (e.g. post-surgery, post-treatment, pre-diagnosis). Full-text articles excluded, withreasons (n=122)b n=81, not relevant (n=60, topic or study type; n=8,excluded systematic reviews; n=9, other prostatecancer topics; n=4, disease); n=16, intervention; n=9,lack of outcome; n=2, year <2008; n=7, duplicate;n=6, sample size; n=1, not available. Total included studies (n=62) Primary studies (n=61)o 1 randomized controlled trial (2015)o 44 observational studies (2013-2016)o 16 observational studies (2008-2013) Systematic review/meta-analysis (n=1)Records excluded based on title(n=1719) Articles from NICE (2014)(n=70) Additional articles (n=2) Full-text articles assessedfor eligibility(n=172) Records identified fromliterature search update (n=521)plus an additional study (n=1) Full-text articles excluded, withreasons (n=17)d n=9, not relevant; n=2, other prostate topics; n=3,intervention; n=1, lack of outcome; n=1, methods notclear; n=1, duplicate study population.Full-text articles assessedfor eligibility (n=29)Records excluded based on title(n=370) and abstract (n=123)c n=123, not relevant (n=84, study type; n=39 topic);n=3, intervention. Draft Guideline 27-3 Appendices – March 29, 2016Page 46Appendix 7. Summary Data and Tables Table 1. Summary of Included Primary Studies (N=61) Author (Year)Study LocationPSA Risk LevelStudyDesignSS Orczyk et al (2016) [42]United States, single-centreLowRCS/PCS31Bittencourt et al (2015) [43]Netherlands, single-centreLowRCS133Boesen et al (2015) [44]Denmark, single-centreIntermediatePCS87Counago et al (2015) [45]Spain, single-centreLowRCS274de Cobelli et al (2015) [46]Italy, single-centreLowRCS223Feng et al (2015) [47]United States, single-centreLowRCS112Ghafoori et al (2015) [4]Iran, single-centreIntermediatePCS238Junker et al (2015) [81]Austria, single-centreLowPCS50Razi et al (2015) [48]Iran, single-centreIntermediatePCS80Reisaeter et al (2015) [49]Norway, single-centreLowRCS63Rud et al (2015) [41]Norway, single-centreLowRCT222/216Schieda et al (2015) [3]Canada, single-centreLowRCS145Woo et al (2015) [50]Korea, single-centreIntermediateRCS117Counago et al (2014) [5]Spain, single-centreLowRCS150Gupta et al (2014) [6]United States, single-centreLowRCS60Kan et al (2014) [7]Hong Kong, single-centreLowRCS56 Kim et al (2014)(a) [8]Korea, single-centreLowRCS167 Kim et al (2014)(b) [9]Korea, single-centreLowRCS100 Kitamura et al (2014) [10]Japan, single-centreLowPCS54 Lawrence et al (2014) [11]United Kingdom, single-centreLowPCS40 Lista et al (2014) [12]Spain, single-centreIntermediatePCS85 Otto et al (2014) [13]Germany, single-centreIntermediateRCS37 Park et al (2014)(a) [14]Korea, single-centreLowRCS353 Park et al (2014)(b) [55]Korea, single-centreLowRCS/PCS282 Roethke et al (2014) [15]Germany, single-centreLowRCS376 Song et al (2014) [16]Korea, single-centreLowRCS382 Styles et al (2014) [17]Australia, single-centre-PCS38 Yao et al (2014) [75]Japan, single-centreLowRCS84 Armitage et al (2013) [18]United Kingdom, single-centre Intermediate RCS/PCS69 Cerantola et al (2013) [19]Switzerland, single-centreIntermediateRCS60 Hegde et al (2013) [20]United States, single-centreLowRCS118 Hole et al (2013) [21]Norway, single-centreIntermediatePCS209 Isebaert et al (2013) [22]Belgium, single-centreIntermediatePCS75 Jeong et al (2013) [23]Korea, single-centreIntermediate RCS/PCS922 Johnston et al (2013) [24]United Kingdom, single-centreLowRCS568 Nepple et al (2013) [25]United States, single-centreLowRCS94 Pak et al (2013) [26]Korea, single-centreIntermediateRCS472 Draft Guideline 27-3 Appendices – March 29, 2016Page 47Porcaro et al (2013) [27]Italy, single-centreIntermediateRCS154 Pugh et al (2013) [28]United States, single-centreLowPCS171 Renard-Penna et al (2013) [30]France, single-centreLowRCS101 Roethke et al (2013) [29]Germany, single-centreLowRCS385 Somford et al (2013) [31]Netherlands, multi-centreIntermediatePCS183 Soylu et al (2013) [32]United States, single-centre IntermediateRCS131 Tanaka et al (2013) [33]Japan, single-centreLowPCS67 Turkbey et al (2013) [34]United States, single-centreLowRCS133 Tsao et al (2013) [35]Taiwan, single-centreIntermediatePCS94 Guzzo et al (2012) [76]United States, single-centreLowRCS172 Jung et al (2012) [77]United States, single-centreLowRCS101 Kim et al (2012) [36]Korea, single-centreIntermediateRCS151 McClure et al (2012) [51]United States, single-centreLowPCS104 Panebianco et al (2012) [53]Italy, single-centreLowPCS105 Hwii Ko et al (2011) [78]Korea, single-centreLowRCS121 Novis et al (2011) [37]Brazil, single-centreLowPCS35 Ploussard et al (2011) [54]France, multi-centreLowRCS/PCS96 Turkbey et al (2011) [38]United States, single-centreLowPCS45 Lee et al (2010)(a) [79]Korea, single-centreIntermediate RCS/PCS67 Lee et al (2010)(b) [39]Korea, single-centreIntermediateRCS91 Turkbey et al (2010) [40]United States, single-centreLowPCS70 Brown et al (2009) [56]United States, single-centreLowRCS62 Zhang et al (2009) [80]United States, single-centreLowRCS158 Cirillo et al (2008) [57]Italy, single-centreLowRCS143 Abbreviations: PCS, prospective case series; PSA, prostate-specific antigen; RCS, retrospective case series; RCT, randomized controlled trial; SS, sample size.a Risk of spread according to mean or median PSA reported in study population: low (<10 ng/mL), intermediate (10-20 ng/mL), high (>20 ng/mL), or PSA categorywith the highest proportion of patients.b After exclusions; intervention/control.c Only a subgroup of 47 patients in Counago et al, 2014 and only a subgroup of 35 patients in Armitage et al, 2013 had magnetic resonance imaging and radicalprostatectomy.d Eligible scans.e Analysis performed by lobes. Draft Guideline 27-3 Appendices – March 29, 2016Page 48Table 2. Detailed Summary of Included Primary Studies (N=61) Study(Year)PatientEnrollmentStudy PopulationCS BpCoreNo.Bp toMRIAge and PSA Results of StudyPopulationPathological Staging Results[no. (%)] Orczyk et al(2016) [42]Pts scheduledfor RP+pre-opMRI, 2011-2012Inclusion: pre-op MRIBp Y NR NR Mean age: 61 yrs (SD: 9.0); meanPSA: 5.8 ng/mL (SD: 2.7)pT0: 1 (3.2), pT2a: 1 (3.2), pT2b: 0(0), pT2c: 18 (58.1), pT3a: 11(35.5)Bittencourtet al (2015)[43]Consecutive ptsto referralcentre, 2010-2013Inclusion: RP, pre-op MRI, prospectivePI-RADS classificationExclusion: prior RT or HT, >6 mo. to RPafter MRIBp Y NR NR Mean age: 61.0 (R: 47.0-72.0);median PSA: 8.6 ng/mL (R: 2.5-76.0)pT2a: 11 (8.3), pT2b: 1 (0.8), pT2c:61 (45.9), pT3a: 44 (33.1), pT3b:11 (8.3), pT4: 5 (3.8) Boesen et al(2015) [44]Pts, 2011-2013 Inclusion: dx PrCa (localized) byDRE+TRUS, RP scheduled, no prior trtExclusion: contraindications to MRIDRE,TRUSY NR NR Median age: 65.0 (R: 47.0-74.0);median PSA: 11.0 ng/mL (4.6-45.0)≤pT2: 55 (63.2); pT3a: 32 (36.8)[31 pts for EPE, 5 pts for EPE+SVI, 1pt for SVI only]Counago etal (2015)[45]Pts, 2009-2015 Inclusion: histological dx PrCa, MRI, trtby RT±HT or RPExclusion: trt prior to MRI, no MRI orCSDRE,TRUSY NR NR Mean age: 66.8 (SD: 8.1); PSA <10ng/mL: 179 (65.3), PSA 10-20ng/mL: 66 (24.1), PSA >20 ng/mL:29 (10.6)pT1-T2a: 23 (25.6), pT2b-T2c: 57(63.3), pT3-T4: 10 (11.1) de Cobelliet al (2015)[46]Pts who had RP,2009-2014Inclusion: pts fulfilled criteria for AS,no HT, had RPDRE,PSA,TRUSY 12 ≥6-8wMean age: 62.3 (SD: 8.3); meanPSA: 6.0 ng/mL (SD: 1.9)pT2a: 23 (10.3), pT2b: 3 (1.4),pT2c: 145 (65.0), pT3a: 45 (20.2),pT3b: 7 (3.1)Feng et al(2015) [47]Consecutive pts,2010-2013Inclusion: had MRI and RPExclusion: prior HT or RT, MRI prior toBpDRE Y NR 4 w Mean age: 62.8 (SD: 7.5); meanPSA: 8.2 ng/mL (SD: 7.2)pT2a/b: 8 (7.1), pT2c: 70 (62.5),pT3a: 15 (13.4), pT3b: 19 (17.0) Ghafoori etal (2015) [4]Pts with provenPrCa, 2011-2013Inclusion: pts proven PrCa by TRUS TRUS Y NR ≥4 w Mean age: 67.4 yrs (SD: 9.0); meanPSA: 16.7 ng/mL (SD: 18.0)pT3b: 63 (23.5), otherwise NR Junker et al(2015) [81]Consecutive pts,2012-2013Inclusion: Bp PrCa, RP, MRI prior tosurgeryExclusion: contraindications, poorpathology resultsBp Y NR ≥3 m Mean age: 63.0 yrs (SD: 8.0); meanPSA: 7.3 ng/mL (SD: 4.3)NR Razi et al(2015) [48]Consecutive pts,2009-2012Inclusion: clinically localized PrCa, hadER+MRS prior to RPDRE,PSA,TRUSY NR 2 w Mean age: 63.5 yrs (SD: 7.7); meanPSA: 16.3 ng/mL (SD: 19.0)pT2: 45 (56.3) pT3: 25 (31.3), pT4:8 (10.0); benign tumour is 2 (2.5) Reisaeter etal (2015)[49]Consecutive pts,2010Inclusion: Bp-proven PrCa, MRI prior toRPExclusion: insignificant PrCa, no dataBp Y NR 14 w Median age: 61.6 yrs (R: 42.9-70.3); median PSA: 8.0 ng/mL (R:3.0-81.4)NR Rud et al(2015) [41]Pts scheduledfor RB, 2009-2012Exclusion: prior prostate MRI, MRIcontraindications, hip prosthesisDRE,TRUSY NR 11 w MRI+DWI, mean age: 62.0 yrs (SD:6.0); median PSA: 7.8 ng/mL (IQR:4.9-11.3); non-MRI: mean age: 63.0yrs (SD: 6.0); median PSA: 8.2ng/mL (IQR: 6.2-18.3)MRI+DWI, pT2: 103 (46.4), pT3 119(53.6)Non-intervention: pT2: 111 (51.4),pT3 105 (48.6) Schieda etal (2015) [3]Consecutive pts,2012-2014Inclusion: RP, pre-op MRI with 3 T, noprior trtPSA,BpY NR NR Mean age: 62.8 yrs (SD: 6.0); meanPSA: 9.0 ng/mL (SD: 8.6)pT3a: 95 (65.5), otherwise NR Draft Guideline 27-3 Appendices – March 29, 2016Page 49Exclusion: lack of RP data, pre-trt Woo et al(2015) [50]Database pts,2013Inclusion: had MRI and then RPExclusion: prior trt, Bp or MRIPSA,BpY NR NR Mean age: 68.0 yrs (SD: 6.8); meanPSA: 12.4 ng/mL (SD: 13.1)pT3a: 50 (42.7), otherwise NR Counago etal (2014) [3]Chart review,2009-2013Inclusion: histological dx of PrCa,MRI+body coil before trt (RP or RT)DRE,TRUSY NR >3 w Mean age: 61.0 yrs (SD: 6.8); PSA<10 ng/mL: 34 (72.3), PSA 10-20ng/mL: 10 (21.1), PSA >20 ng/mL:1 (2.1), unkwn: 2 (4.2)pT2a: 5 (10.6), pT2b: 5 (10.6),pT2c: 30 (63.8), pT3a: 4 (8.5),pT3b: 3 (6.4) Gupta et al(2014)[6]Pts undergoingMRI for PrCa,2011Inclusion: complete MRI then RPExclusion: incomplete MRI, pre-trt, ERunable.DRE Y NR 13 w Mean age: 60.1 yrs (SD: 7.3); meanPSA: 6.9 ng/mL (R: 1.2-46.3)≤pT2: 38 (63.3); pT3a: 18 (30.0);pT3b: 4 (6.7) Kan et al(2014) [7]Consecutive ptsof RP, 2010-2012Inclusion: 12-core Bp+pathologyreports.TRUS Y ≥ 12 NR Age: NR; PSA <10 ng/mL: 64 (64.0),PSA 10-20: 29 (29.0), PSA >20: 7(7.0)NR Kim et al(2014)(a) [8]Referrals, 2006-2008Inclusion: Bp-proven PrCa, no hx trt,MRI prior to surgery.Bp Y NR 3 w Mean age: 66.5 yrs (R: 52.0-78.0);mean PSA: 8.5 ng/mL (R: 1.1-37.3)pT3a: 23 (13.8); pT3b: 7 (4.2) Kim et al(2014)(b) [9]Hospitalmedical data,2008-2012Inclusion: dx by 12-core TRUS Bp,localized, core length ≤7 mm, totalcancer length ≤10 mm, low D’Amicorisk, pre-trt MRI, negative bone scans.TRUS Y 12 ≥6 w Median age: 63.3 yrs (R: 51.0-76.0); median PSA: 6.5 ng/mL (R:2.2-9.5)pT2a: 28 (28.0), pT2b: 23 (23.0),pT2c: 36 (36.0), pT3a: 10 (10.0),pT3b: 3 (3.0) Kitamura etal (2014)[10]Consecutive pts,2009-2013Inclusion: cT1c-T2N0M0 Bp-provenlocalized PrCa, MRI plus TRUS,followed by RP, no hx trtBp Y NR NR Mean age: 62.7 yrs (SD: 6.4);median PSA: 5.7 ng/mL (4.4-7.6)pT2a: 17 (31.5), pT2b: 2 (3.7),pT2c: 24 (44.4), pT3a: 7 (13.0),pT3b: 4 (7.4)Lawrence etal (2014)[11]PrCa pts, 2010-2014Inclusion: Bp-proven PrCa ofintermediate to high-risk as defined,plan for RP, Bp ≥6 wks prior to MRIDRE Y NR ≥6 w Median age: 62.5 yrs (R: 42.0-73.0); median PSA: 7.3 ng/mL(R:0.6-14.6)≤pT2: 17 (42.5); pT3a: 23 (57.5) Lista et al(2014) [12]Prca ptsInclusion: proximity of PrCa to NVB inpts for NS RP, need for extended pre-op planning in high-risk ptsDRE,TREY NR 4 w Mean age: 63.7 yrs (SD: 6.9); meanPSA: 12.6 ng/mL (SD: 13.8)pT2a: 12 (14.1), pT2b: 3 (3.5),pT2c: 37 (43.5), pT3a: 19 (22.3),pT3b: 14 (16.5)Otto et al(2014) [13]Consecutive pts,2010Inclusion: histologically dx PrCaExclusion: contraindications to MRIPSA,TRUSY μ:11.68 w Mean age: 65.0 yrs (R: 53.0-75.0);median PSA: 13.5 ng/mL (R: 3.7-56.0)pT3a: 10 (27.0); pT3b: 5 (13.5) Park et al(2014)(a)[14]Pts who had RB,2008-2011Inclusion: Bp-proven PrCaExclusion: hx trt (HT or RT), MRIperformed at other institutionsBp,DRE,PSAY NR ≥3 w Median age: 64.0 yrs (R: 43.0-73.0); median PSA: 5.3 ng/mL (R:1.7-58.5)NR Park et al(2014)(b)[55]Consecutive ptswith PrCa+RP,2007-2009Exclusion: hx trt (HT or RT), poorimaging quality, missing clinical data,lack of FU dataDRE Y NR 4 w Median age: 64.0 yrs (R: 38.0-88.0); median PSA: 6.6 ng/mL (R:0.3-57.0)pT3a: 68 (24.0); pT3b: 22 (8.0);pLNM: 2 (0.7) Roethke etal (2014)[15]Referrals, 2004-2008Inclusion: Bp-proven PrCa scheduledfor RPExclusion: hx trt (HT or RT)Bp Y NR ≥6 w Median age: 63.0 yrs (R: 43.0-6.0);median PSA: 8.8 ng/mL (R: 1.1-2.5)pT3b: 35 (9.3) Song et al(2014) [16]MRR, 2007-2012 Inclusion: 12-core Bp, pre-op MRI, RP,low risk PrCa by D’AmicoBp Y 12 NR Mean age: 64.1yrs (SD: 7.6); meanPSA: 5.1 ng/mL (SD: 1.8)pT2: 330 (86.4), pT3a: 49 (12.8),pT3b: 2 (0.5) Draft Guideline 27-3 Appendices – March 29, 2016Page 50Styles et al(2014) [17]Pts, 2010-2012 Inclusion: Bp-proven PrCa, localizedbased on clinical staging, undergo RPpost-MRIDRE Y NR 3-8 w Mean age: 60.0 yrs (R: 42-73); PSA:NRNR Yao et al(2014) [75]Consecutive pts,2010-2012Inclusion: dx PrCa by TRUS, RPExclusion: hx HTPSA,TRUSY 8-14 >4 w Mean age: 64.0 yrs (SD: 7.0); meanPSA: 9.3 ng/mL (R: 2.7-34.6)pT2: 59 (70.2); pT3a: 21 (25.0);pT3b: 4 (4.8) Armitage etal (2013)[18]Databasereview, all RPpts, 2008Inclusion: all pts who had a RPCS Y NR 6 w Mean age: 64.1 yrs (R: 46-74); PSA≤10 ng/mL: 4 (5.8), PSA 10-20ng/mL: 58 (84.1), PSA >20 ng/mL:7 (10.1)≥pT3: 22/35 (62.9) Cerantola etal (2013)[19]All RP pts, 2008-2012Inclusion: MRI performed in single-centreDRE,PSA,TRUSY 12 ≥3 w Mean age: 67.0 yrs (SD: 7.0); meanPSA: 12.7 ng/mL (SD: 12.7)pT2a: 3 (5), pT2b: 1 (1.7), pT2c:25 (41.7), pT3a: 22 (36.7), pT3b: 7(11.7), pT4: 2 (3.3)Hegde et al(2013) [20]RP pts+pre-op3T MRI, 2008-2011Inclusion: no hx trt, dx cT1-cT2 PrCaand suspicion of T3 diseasePSA,TRUSY ≥12(86%ofmen)6 w ~Age: 58.7 yrs (R: 52.4-65.2); ~PSA:6.5 ng/mL (R: 3.1-10.3)pT2a: 10 (8.5), pT2b: 3 (2.5),pT2c: 76 (64.4), pT3a: 19 (16.1),pT3b: 10 (8.5) Hole et al(2013) [21]Consecutive pts,pre-op MRI+RP,2007-2010Inclusion: PrCa pts, pre-op MRI, RPExclusion: no hx trt, no skeletalmetastasesDRE,TRUSY NR 13 w Mean age: 62.5 yrs (SD: 5.9); meanPSA: 19.8 ng/mL (SD: 29.4)pT2a: 11 (5.3), pT2b: 0 (0), pT2c:62 (29.7), pT3a: 96 (45.9), pT3b:34 (16.3); pT4: 5 (2.4); Tx: 1 (0.5)Isebaert etal (2013)[22]Consecutive pts,2008-2011Inclusion: newly dx Bp-proven PrCa,intermediate to high-risk PrCa byD’Amico, no PLN by CE-CT and LNMrisk ≥10% and ≤35% by Partin tables,negative bone scanPSA,TRUSY NR ≥4 w Median age: 66.0 yrs (R: 49.0-74.0); median PSA: 10.4 ng/mL (R:1.5-70.9)pT2b: 2 (2.7), pT2c: 31 (41.3),pT3a: 20 (26.7), pT3b: 19 (25.3);pT4: 3 (4.0) Jeong et al(2013) [23]Consecutive pts,PrCa+RP+PL,2000-2012Inclusion: MRI, high-risk, treated RPExclusion: hx trtBp Y NR 4 w Mean age: 66.1 yrs (SD: 6.7);medan PSA: 10.7 ng/mL (R: 0.3-737.0)≤pT2: 387 (41.9); pT3a: 530 (57.5);pT3b: 117 (12.7); pLN: 58 (6.3) Johnston etal (2013)[24]Databasereview, all pts,RB-RP+pre-opMRI, 2005-2011Inclusion: pts undergoing RB-RP andhad a pre-op MRICS Y NR 4 w Median age: 62.0 yrs (R: 35.0-74.0); median PSA: 8.7 ng/mL(R:0.5-63.0)pT3a: 280 (49.3), pT3b: 34 (6.0) Nepple et al(2013) [25]Consecutive pts,RP+pre-op MRI,2003-2008Inclusion: PrCa with risk factors forlocal extension (gleason grade ≥4 +3,PSA ≥10 ng/mL, abnormal DRE, orextensive Bp involvement)Bp,DRE,PSAY NR 6 w Median age: 61.0 yrs (48.0-72.0);median PSA: 7.0 ng/mL (R: 1.3-35.0)pT3a: 22 (24.2); pT3b: 8 (8.8) Pak et al(2013) [26]Referral pts,RP, 2007-2012Inclusion: undergoing RPExclusion: hx trt, pts without detailedinformationDRE,PSA,TRUSY 12 NR ~Age: 65.3 yrs; ~PSA: 11.7 ng/mL pT3a: 194 (20.6) Porcaro(2013) [27]Pts pre-op MRI,2003-2006Exclusion: pts using 5-alpha reductaseinhibitors, LH-releasing hormoneanalog, anti-androgens or testosteronereplacement treatmentBp,DREPSAY NR NR Mean age: 66.0 yrs (SD: 6.0); meanPSA: 11.0 ng/mL (SD: 11.4)pT2: 97 (63.0), pT3a: 41 (26.6),pT3b: 16 (10.4) Pugh et al(2013) [28]Consecutive pts,2006-2010, RBInclusion: T1c-T2c, pre-trt PSA <10ng/mL, GS of 7, and pre-surgery MRIPSA,TRUSY NR NR Median age: 60.0 yrs (R: 42.0-76.0); median PSA: 4.9 ng/mL (R:pT2a: 114 (66.7), pT3a: 38 (22.2),pT3b: 19 (11.1) Draft Guideline 27-3 Appendices – March 29, 2016Page 51RP0.4-9.9) Renard-Penna et al(2013) [30]Consecutive pts,pre-op MRI + RP,2009-2010Inclusion: Bp-proven PrCa, RP plannedwithin 1 mo. after MRI, ≥8 w betweenbiopsy and MRI, able pts for MRI, no hxHTDRE Y NR ≥8 w Median age: 60.0 yrs (R: 39.0-71.0); mean PSA: 8.0 ng/mL (SD:4.4)pT2a: 8 (7.9), pT2b: 10 (9.9), pT2c:67 (66.3), pT3a: 10 (9.9), pT3b: 6(5.9) Roethke etal (2013)[29]Pts referrals,2003-2008Inclusion: Bp-proven PrCa, pre-op MRI,RPExclusion: hx HT or RTBp,PSAY NR ≥6 w Mean age: 62.7 yrs (R: 42.0-77.0);mean PSA: 8.9 ng/mL (R: 0.4-52.5)pT2: 268 (69.6), ≥ pT3: 117 (30.4) Somford etal (2013)[31]Consecutive pts,RP, 2007-2010Exclusion: pts with extensive T3 PrCanot considered for RP, nodalmetastasis on MRIDRE Y 8-12coresNR Mean age: 62.4 yrs (SD: 4.9); meanPSA: 10 ng/mL (SD: 8.4)pT2: 92 (50.3), pT3: 91 (49.7)[pT3b: 21 (11.5%)] Soylu et al(2013) [32]Consecutive pts,pre-op MRI+RP,2007-2010Exclusion: hx trt (HT, RT, CT),incomplete MRI examinationBp Y NR NR Median age: 68.0 yrs (R: 43.0-75.0); median PSA: 12.1 ng/mL (R:1.5-65.0)pT3b: 23 (17.6) Tanaka et al(2013) [33]Pts, T2 or T3 onMRI, 2010-2012Exclusion: no hx HTBp Y 12 ≥8 w Median age: 67.0 yrs (R: 51.0-74.0); median PSA: 7.0 ng/mL (R:2.87-27.6)pT2a: 11 (16.4), pT2b: 6 (9.0),pT2c: 33 (49.3), pT3a: 15 (22.4),pT3b: 2 (3.0)Turkbey etal (2013)[34]Pts, 2007-2010 Inclusion: clinical-pathologicparameters available to calculate ASeligibility by established risk criteria,pre-op mpMRI at 3.0 T followed by RBDREPSA,BpY NR NR Median age: 59.0 yrs (R: 39.0-74.0); median PSA: 4.4 ng/mL (R:0.9-48.9)pT3a: 46 (34.6); pT3b: 6 (4.5) Tsao et al(2013) [35]Dx PrCa pts,2001-2007Inclusion: pre-op MRI, RPExclusion: hx HT or RTDREorPSAY 10-12 >6 w Mean age: 68.9 yrs (R: 50.0-85.0);mean PSA: 16.9 ng/mL (R: 0.1-107.0)pT2a: 65 (69.1), pT3a: 12 (12.8),pT3b: 17 (18.1) Guzzo et al(2012) [76]Databasereview,consecutive RPpts, 1991-2007Inclusion: pre-op MRI+clinical criteriafor AS (Johns Hopkins expectantmanagement program)Bp,PSAY NR NR Mean age: 59.8 yrs (SD: 6.2); meanPSA: 5.2 ng/mL (SD: 2.2)pT2a: 105 (76.1), pT2b: 3 (2.2),pT2c: 17 (12.3), pT3a: 11 (8.0),pT3b: 2 (1.4) Jung et al(2012) [77]Databasereview,consecutive pts,1997-2009Inclusion: Bp-proven PrCa, pre-op MRI,RPExclusion: hx neoadjuvant therapyBp,PSAY NR ≥6 w Mean age: 59.0 yrs (R: 42.0-75.0);median PSA: 6.9 ng/mL (R: 1.1-38.0)pT3: 23 (22.7); otherwise NR Kim et al(2012) [36]Consecutive pts,2005-2010Inclusion: Bp-proven PrCa, RPExclusion: contraindications for MRI,hx neoadjuvant HT or RT, <3 wbetween Bp and MRIBp,PSAY NR 4 w ~Age: 65.8 yrs (R: 47.0-76.0); ~PSA:12.0 ng/mL (R: 22.0-45.0)pT3a: 81 (53.6); pT3b: 34 (22.5);otherwise NR McClure etal (2012)[51]Consecutive pts,2004-2008Inclusion: had MRI + ER prior to RBExclusion: open RPBp,PSAY NR 13 w Mean age: 60.1 yrs (SD: 6.8); meanPSA: 6.5 ng/mL (SD: 4.7)pT2: 198 (95.2); pT3: 10 (4.8) Panebiancoet al (2012)[53]Consecutive pts,2006-2010Inclusion: Bp-proven PrCa, BL/NS/RPbased on clinical assessment [T1c orT2a, PSA <10 ng/mL, GS <8, only 1 BpDRE,PSA,TRUSY 12 ≥6 w Median age: 57.0 yrs (R: 48.0-66.0); ~median PSA: 5.5 ng/mL: (R:2.5-9.8)pT2a: 36 (34.3), pT2b: 58 (55.2),pT3a: 11 (10.5), pT3b: 0 (0) Draft Guideline 27-3 Appendices – March 29, 2016Page 52GS >6 at ipsilateral sideExclusion: hx HT/RT/CT, prior prostatesurgery, contraindications for MRIHwii Ko etal (2011)[78]Pts, 2007-2009 Inclusion: clinical stage T1c to T3c, dxPrCa by TRUS, RP, pre-op MRIExclusion: hx HT, RT or aby ablativetechniqueBp,DREY NR 4 w Mean age: 62.8 yrs (R: 46.0-74.0);mean PSA: 9.6 ng/mL (R: 0.4-24.4)pT2a: 17 (14.0), pT2b: 11 (9.1),pT2c: 50 (41.3), pT3a: 21 (17.4),pT3b: 7 (5.8); pT3c: 10 (8.3); pT4:5 (4.1)Novis et al(2011) [37]Referral pts,2005-2006Inclusion: US-guided Bp-proven PrCa,no hx HT, RP candidate, T1c-T2a, GS≤6, PSA ≤10 ng/mLBp,DRE,PSAY NR ≥3 w Mean age: 64.9 yrs (R: 50.0-77.0);mean PSA: 6.1 ng/mL (R: 2.6-10.0)pT2a: 2 (5.7), pT2b: 3 (8.6), pT2c:11 (31.4), pT3a: 8 (22.9), pT3b: 3(8.6)Ploussard etal (2011)[54]Pts, 21-core Bpfor PSA >0.7ng/mL/yr, abDRE, PSA >4ng/mL and/orPSA-R <10%,2001-2008Inclusion: PSA ≤10 ng/mL, T1-T2a, GS≤6, >10 yrs life expectancy (<65 yrsw/o comorbidities, >65 yrs w/ooncogeriatrics medical visit)Exclusion: tumour ≥3 cores,length/core ≥3 mm, no RP, no pre-opMRIBp,DRE,PSAY 21 ≥6 w Mean age: 62.4 yrs (R: 51.0-73.2);mean PSA: 6.1 ng/mL (R: 1.8-10.0)pT2a: 26 (27.1), pT2b: 2 (2.1),pT2c: 50 (52.1), pT3: 17 (17.7)[EPE: 16 (16.7), SVI: 1 (1.0)] Turkbey etal (2011)[38]Consecutive pts,2008-2009Inclusion: Bp-proven PrCa, RB within180 days of pre-op MRI w/o anytreatmentExclusion: contraindications to MRI orERBp,PSAY NR ≥10 w Median age: 60.0 yrs (R: 49.0-75.0); median PSA: 5.8 ng/mL (R:2.3-23.7)pT3a: 12 (26.7); pT3b: 2 (4.4) Lee et al(2010)(a)[79]Pts, 1998-2006 Inclusion: cT3 PrCa, RPP, pre-op MRIExclusion: hx HT or RTDRE,PSA,TRUSY 6-10 >3-4w~Age: 64.5 yrs; ~PSA: 13.7 ng/mL(2.7-207.0)≤pT2c: 53 (79.1), pT3a: 3 (4.5),pT3b: 11 (16.4) Lee et al(2010)(b)[39]Record review,consecutive pts,2007-2009Inclusion: pre-op 1.5 T MRI with ER orpelvic coil, RPExclusion: positive nodes, bonemetastasis, technical difficulties withimaging or pathologyBp,PSAY ~11.8 3 w Mean age: 63.0 yrs (SD: 1.5); meanPSA: 10.7 ng/mL (SD: 1.9)pT2: 34 (37.4); pT3a: 49 (53.8);pT3b: 8 (8.8) Turkbey etal (2010)[40]Pts, 2004-2007 Inclusion: TRUS Bp-proven PrCa, RPperformed within 180 days of imagingand no trtExclusion: contraindication to MRI,unable for ERBp,PSAY NR 12 w Mean age: 60.4 yrs (R: 40.0-75.0);mean PSA: 5.5 ng/mL (1.0-19.9)pT2: 47 (67.1); pT3: 23 (32.9) Brown et al(2009) [56]Pts, RP+pre-opMRI, 2002-2005Inclusion: pts able and willing toundergo MRI, risk of ECE based on pre-op assessmentBp,PSAY NR ≥8-10wMean age: 58.0 yrs (R: 42.0-73.0);median PSA: 6.1 ng/mL (R: 0.5-30.5)pT2: 41 (66.1), pT3: 21 (33.9) Zhang et al(2009) [80]Consecutive pts,2003-2004Inclusion: 1.5 T MRI+post-RP in timeperiod, T1c PrCa, pathology availableExclusion: hx HT/CT/RTBp,PSAY NR 10 w Median age: 58.0 yrs (R: 40.0-76.0); median PSA: 5.3 ng/mL(R:1.5-21.0)pT2: 124 (78.5), pT3a: 29 (18.4),pT3b: 2 (1.3), pT4: 2 (1.3) [Notumour: 1 (0.6)]Cirillo et al(2008) [57]Pts, 2002-2005 Inclusion: Bp-proven PrCa+pre-op MRI Bp,DRE,PSAY NR NR Mean age: 70 yrs (R: 52.0-83.0);mean PSA: 9.1 ng/mL (R: 1.6-136.5)NR Draft Guideline 27-3 Appendices – March 29, 2016Page 53Abbreviations: ab, abnormal; Bp, biopsy; CE-CT, contrast-enhanced computed tomography; CS, clinical staging; CT, chemotherapy; d, days; DCE, dynamic contrast-enhanced imaging; DRE, digital rectal examination;DWI, diffusion-weighted imaging; dx, diagnosis; EPE, extraprostatic extension; ER, endorectal coil; grps, groups; HT, hormone therapy; hx, history; IQR, interquartile range; LN, lymph node; LNM, lymph nodemetastasis; M, median; mo, months; μ, mean; MRI; MRI, magnetic resonance imaging ± DCE, DWI, MRS; MRR, medical record review; MRS, magnetic resonance spectroscopic imaging; pts, patients; NR, not reported;OCD, organ-confined disease; p, pathology; PL, pelvic lymphadenopathy; PLN, pelvic lymph nodes; PrCa, prostate cancer, pre-op, preoperative; PSA, prostate-specific antigen; PSA-R, free-to-total PSA ratio; R, range;RB, robotic-assisted surgery; RP, radical prostatectomy; RT, radiation therapy; SD, standard deviation; SVI, seminal vesicle invasion; T, Tesla; trt, treatment; TRE, transrectal echography; TRUS, transrectal ultrasound;US, ultrasound; w, weeks; w/o, without.a Additional information taken from prior Feng et al, 2015 study [88].b Pathology, for n=381 patients.c Of 91 patients with final pathology data.d Remainder of pathology stage data not presented, therefore presented data does not add up to the total sample size of 133.e Pathology, for n=138 patients.f Clinical criteria includes PSA density ≤0.15 ng/mL/cm, no more than 2 biopsy cores positive for cancer, no more than 50% of 1 core involved with cancer, and no Gleason pattern 4 or 5 identified on biopsy.g Percentages do not add up to 100% and sample size only to 95, based on original paper. Note 1. The mean and corresponding SD or median and corresponding ranges were abstracted when available. Otherwise, the mean and range were abstracted where available, or mean alone. When the original paperprovided age or PSA among subgroups, the average was calculated. This is indicated in tables as ~. Where ranges were quite extreme, the median was presented in lieu of the mean.Note 2. OCD translated to ≤pT2, EPE translated to pT3a, and SVI translated to pT3b. Draft Guideline 27-3 Appendices – March 29, 2016Page 54Table 3. Summary: Use of MRI ± DCE, DWI, MRS (N=61 Studies) Author (Year)ExperiencedReaderComplete/PartiallyBlinded 1.5 T MRI 3 T MRIERBC/PC+DCE+DWI +MRS Randomized Controlled Trials (n=1)Rud et al (2015) [41]√√√√Observational Studies (n=66)Orczyk et al (2016) [42]√√√√√√Bittencourt et al (2015) [43]√√√√√√Boesen et al (2015) [44]√√√√√√Counago et al (2015) [45]√√√√√de Cobelli et al (2015) [46]√√√√Feng et al (2015) [47]√√√√√√Ghafoori et al (2015) [4]√√√√Junker et al (2015) [81]√√√√√√Razi et al (2015) [48]√√√√√Reisaeter et al (2015) [49]√√√√√√√Schieda et al (2015) [3]√√√√√Woo et al (2015) [50]√√√√Counago et al (2014) [5]√√√√√Gupta et al (2014) [6]√√√√√√√Kan et al (2014) [7]√√√√Kim et al (2014)(a) [8]√√√√√Kim et al (2014)(b) [9]√√√√√√Kitamura et al (2014) [10]√√√√√√√Lawrence et al (2014) [11]√√√√√Lista et al (2014) [12]√√√√√Otto et al (2014) [13]√√√√√√√√Park et al (2014)(a) [14]√√√√√√Park et al (2014)(b) [55]√√√√√√Roethke et al (2014) [15]√√√√Song et al (2014) [16]√√√√Styles et al (2014) [17]√√√√√√Yao et al (2014) [75]√√√Armitage et al (2013) [18]√√√Cerantola et al (2013) [19]√√√√√Hegde et al (2013) [20]√√√√√√Hole et al (2013) [21]√√√√Isebaert et al (2013) [22]√√√√√√Jeong et al (2013) [23]√√√√√√Johnston et al (2013) [24]√√Nepple et al (2013) [25]√√√Pak et al (2013) [26]√√√ Draft Guideline 27-3 Appendices – March 29, 2016Page 55Abbreviations: BC, body coil; DCE, dynamic contrast-enhanced imaging; DWI, diffusion-weighted imaging; ER, endorectal coil; PC, pelvic/phased-array coil; MRI, magnetic resonance imaging; MRS, magnetic resonancespectroscopic imaging; T, Tesla.a Staging protocol (n=89 patients) used ER plus pelvic coil, whereas detection protocol (n=44 patients) used pelvic coil only.b Cardiac coil.c Torso array coil. Note 1. “√” indicates presence of characteristic whereas a shaded cell indicates the absence of the column characteristic and “+” indicates the addition of.Note 2. Experienced reader defined as any experience such as: “specializes” or “experience” or “dedicated” or “radiology specialist” for example, as stated in original paper.Porcaro et al (2013) [27]√√√√√Pugh et al (2013) [28]√√√√Renard-Penna et al (2013) [30]√√√√√Roethke et al (2013) [29]√√√√Somford et al (2013) [31]√√√√√√√Soylu et al (2013) [32]√√√√√√√Tanaka et al (2013) [33]√√√√Turkbey et al (2013) [34]√√√√√√√√Tsao et al (2013) [35]√√√Guzzo et al (2012) [76]√√√√√Jung et al (2012) [77]√√√√√Kim et al (2012) [36]√√√√McClure et al (2012) [51]√√√√√√√Panebianco et al (2012) [53]√√√√√√√√Hwii Ko et al (2011) [78]√√√√Novis et al (2011) [37]√√√√√√√Ploussard et al (2011) [54]√√√√Turkbey et al (2011) [38]√√√√√√√√Lee et al (2010)(a) [79]√√√Lee et al (2010)(b) [39]√√√√Turkbey et al (2010) [40]√√√√√√√Brown et al (2009) [56]√√√√Zhang et al (2009) [80]√√√√√√Cirillo et al (2008) [57]√√√ Draft Guideline 27-3 Appendices – March 29, 2016Page 56Table 4. Outcome: Diagnostic Accuracy (N=49 Studies) Study (Year)% Sensitivity (95% CI)% Specificity (95% CI)% PPV (95% CI)% NPV (95% CI) Orczyk et al(2016) [42]MRI+DCE+DWI: 52.6MRI+DCE+DWI: 96.5MRI+DCE+DWI: 87.2MRI+DCE:DWI: 81.6 Bittencourt etal (2015) [43]MRIEPE: 98.0 (96.0-100.0)MRI+DCEEPE: 82.0 (68.0-90.0)MRI+DWIEPE: 95.0 (86.0-99.0) MRI: 68.0MRI+DCE: 55.0MRI+DWI: 80.0MRIEPE: 32.0 (24.0-39.0)MRI+DCEEPE: 33.0 (22.0-44.0)MRI+DWIEPE: 27.0 (18.0-39.0) MRI: 68.0MRI+DCE: 73.0MRI+DWI: 55.0MRIEPE: 54.0 (46.0-63.0)MRI+DCEEPE: 50.0 (39.0-60.0)MRI+DWIEPE: 52.0 (42.0-61.0) MRI: 64.0MRI+DCE: 62.0MRI+DWI: 57.0MRIEPE: 96.0 (92.0-99.0)DCEEPE: 69.0 (50.0-83.0)DWIEPE: 87.0 (66.0-97.0) MRI: 72.0MRI+DCE: 66.0MRI+DWI: 76.0Boesen et al(2015) [44]MRI+DCE+DWIEPE: 81.0 (63.0-93.0)MRI+DCE+DWISVI: 80.0 (29.0-97.0)MRI+DCE+DWIEPE: 78.0 (66.0-88.0)MRI+DCE+DWISVI: 99.0 (93.0-99.0)MRI+DCE+DWIEPE: 68.0 (50.0-82.0)MRI+DCE+DWISVI: 80.0 (29.0-97.0)MRI+DCE+DWIEPE: 88.0 (76.0-95.0)MRI+DCE+DWISVI: 99.0 (93.0-99.0)Counago et al(2015) [45]MRI+DCE+DWI: 70.0 (41.6-98.4) MRI+DCE+DWI: 93.8 (88.5-99.1) MRI+DCE+DWI: 58.3 (30.4-86.2)MRI+DCE+DWI: 96.2 (91.9-100) de Cobelli etal (2015) [46]MRI+DCE+DWIEPE: 100.0 (93.0-100.0)MRI+DCE+DWISVI: 100.0 (59.0-100.0)MRI+DCE+DWIEPE: 10.0 (6.0-15.0)MRI+DCE+DWISVI: 8.0 (4.0-12.0)MRI+DCE+DWIEPE: 25.0 (20.0-32.0)MRI+DCE+DWISVI: 3.0 (1.0-7.0)MRI+DCE+DWIEPE: 100.0 (79.0-100.0)MRI+DCE+DWISVI: 100.0 (79.0-100.0)Feng et al(2015) [47]MRI+DCE+DWIEPE: 84.6MRI+DCE+DWIEPE: 87.2MRI+DCE+DWIEPE: 66.7MRI+DCE+DWIEPE: 94.9 Ghafoori et al(2015) [4]MRISVI: 97.0 (89.0-99.0)MRISVI: 98.0 (94.0-99.0)MRISVI: 94.0 (85.0-98.0)MRISVI: 99.0 (96.0-99.0) Razi et al(2015) [48]MRI+MRS: 42.4MRI+MRS: 93.6MRI+MRS: 82.3MRI+MRS: 69.8 Reisaeter etal (2015) [49]MRIPZ: 0.50 (0.44-0.55)MRITZ: 0.13 (0.05-0.25)MRI+DWIPZ: 0.56 (0.50-0.62)MRI+DWITZ: 0.17 (0.08-0.29)MRI+DCEPZ: 0.51 (0.45-0.57)MRI+DCETZ: 0.13 (0.05-0.25)MRI+DCE+DWIPZ: 0.60 (0.55-0.66)MRI+DCE+DWITZ: 0.15 (0.07-0.27)MRIPZ: 0.79 (0.76-0.82)MRITZ: 0.94 (0.92-0.96)MRI+DWIPZ: 0.83 (0.80-0.85)MRI+DWITZ: 0.94 (0.91-0.96)MRI+DCEPZ: 0.83 (0.81-0.86)MRI+DCETZ: 0.97 (0.95-0.98)MRI+DCE+DWIPZ: 0.80 (0.77-0.83)MRI+DCE+DWITZ: 0.95 (0.93-0.97)MRIPZ: 0.47 (0.42-0.55)MRITZ: 0.19 (0.08-0.36)MRI+DWIPZ: 0.55 (0.49-0.60)MRI+DWITZ: 0.22 (0.11-0.38)MRI+DCEPZ: 0.54 (0.48-0.59)MRI+DCETZ: 0.32 (0.14-0.55)MRI+DCE+DWIPZ: 0.53 (0.48-0.58)MRI+DCE+DWITZ: 0.24 (0.11-0.42)MRIPZ: 0.81 (0.78-0.83)MRITZ: 0.91 (0.89-0.94)MRI+DWIPZ: 0.83 (0.81-0.86)MRI+DWITZ: 0.91 (0.89-0.94)MRI+DCEPZ: 0.82 (0.79-0.84)MRI+DCETZ: 0.91 (0.89-0.94)MRI+DCE+DWIPZ: 0.84 (0.81-0.87)MRI+DCE+DWITZ: 0.91 (0.89-0.94)Rud et al(2015) [41]MRI+DWI: 73.0 (63.0-81.0)MRI+DWI: 65.0 (54.0-74.0)NRNR Schieda et al(2015) [3]MRI+DCE+DWIEPE: 59.5 (49.1-68.2) MRI+DCE+DWIEPE: 68.0 (50.5-82.6)NRNR Woo et al(2015) [50]MRIEPE: 30.0 (17.9-44.6)MRI+DWIEPE: 92.0 (80.8-97.8)MRIEPE: 92.5 (83.4-97.5)MRI+DWIEPE: 55.2 (42.6-67.4)NRNR Counago et al(2014) [5]MRI+DCE+DWIEPE: 57.1 (25.0-84.1) MRI+DCE+DWIEPE: 95.0 (83.0-98.0) MRI+DCE+DWIEPE: 66.6 (29.0-100)MRI+DCE+DWIEPE: 92.6 (85.0-100) Gupta et al(2014) [6]MRI+DCE+DWIOCD: 81.6MRI+DCE+DWIEPE: 77.8MRI+DCE+DWIOCD: 86.4MRI+DCE+DWIEPE: 83.4MRI+DCE+DWIOCD: 91.2MRI+DCE+DWIEPE: 66.7MRI+DCE+DWIOCD: 73.1MRI+DCE+DWIEPE: 89.7Kan et al(2014) [7]MRI+DWIEPE: 5.9MRI+DWIEPE: 94.9MRI+DWIEPE: 33.3MRI+DWIEPE: 69.8 Kim et alMRI+DWIEPE: 75.0MRI+DWIEPE: 70.0NRNR Draft Guideline 27-3 Appendices – March 29, 2016Page 57(2014)(a) [8]Kim et al(2014)(b) [9]MRI: 32.3 (25.5-37.2)MRI+DCE: 27.2 (22.7-32.6)MRI+DWI: 43.5 (38.8-50.8)MRI: 94.0 (92.0-96.1)MRI+DCE: 93.2 (91.6-94.9)MRI+DWI: 91.1 (89.3-94.0)MRI: 75.0 (71.6-86.2)MRI+DCE: 71.7 (67.3-79.9)MRI+DWI: 77.1 (72.2-85.0)MRI: 66.2 (61.2-72.0)MRI+DCE: 63.2 (58.6-69.5)MRI+DWI: 69.8 (65.8-74.5)Kitamura et al(2014) [10]MRI: 48.0DWI: 44.0MRS: 29.0MRI+DWI: 56.0MRI+MRS: 62.0MRI+DWI+MRS: 68.0MRI: 81.0DWI: 93.0MRS: 86.0MRI+DWI: 79.0MRI+MRS: 65.0MRI+DWI+MRS: 63.0MRI: 68.0DWI: 84.0MRS: 62.0MRI+DWI: 69.0MRI+MRS: 60.0MRI+DWI+MRS: 61.0MRI: 65.0DWI: 66.0MRS:58.0MRI+DWI: 68.0MRI+MRS: 67.0MRI+DWI+MRS: 70.0Lawrence etal (2014) [11]MRIEPE: 22.0 (10.0-41.0)MRI+DWIEPE: 44.0 (27.0-64.0)MRIEPE: 85.0 (73.0-92.0)MRI+DWIEPE: 83.0 (71.0-91.0)MRIEPE: 43.0 (20.0-69.0)MRI+DWIEPE: 57.0 (36.0-76.0)MRIEPE: 68.0 (56.0-78.0)MRI+DWIEPE: 75.0 (61.0-85.0)Lista et al(2014) [12]MRIEPE: 33.0MRI+DCE+DWIEPE: 58.0MRISVI: 50.0MRI+DCE+DWISVI: 75.0MRIEPE: 96.0MRI+DCE+DWIEPE: 98.0MRISVI: 94.0MRI+DCE+DWISVI: 96.0MRIEPE: 84.0MRI+DCE+DWIEPE: 95.0MRISVI: 66.0MRI+DCE+DWISVI: 80.0MRIEPE: 69.0MRI+DCE+DWIEPE: 75.0MRISVI: 89.0MRI+DCE+DWISVI: 94.0Otto et al(2014) [13]MRI+DCE+DWI(+MRS)EPE: 90.0MRI+DCE+DWI(+MRS)SVI: 80.0MRI+DCE+DWI(+MRS)EPE: 74.0MRI+DCE+DWI(+MRS)SVI: 96.0NR-NRPark et al(2014)(a) [14]MRI+DCE+DWIT3: 55.9MRI+DCE+DWIT3: 82.2MRI+DCE+DWIT3: 59.1MRI+DCE+DWIT3: 80.2 Roethke et al(2014) [15]MRISVI: 48.6MRISVI: 97.7MRISVI: 68.0MRISVI: 94.9 Song et al(2014) [16]MRI+DWIANT-T: 65.1MRI+DWIPOST-T: 72.2MRI+DWIANT-T: 88.8MRI+DWIPOST-T: 78.9MRI+DWIANT-T: 76.3MRI+DWIPOST-T: 86.0MRI+DWIANT-T: 82.1MRI+DWIPOST-T: 61.2Styles et al(2014) [17]MRI: 53.2DWI: 62.3NR-NR-NRArmitage et al(2013) [18]MRIEPE: 41.0 (23.0-61.0)MRIEPE: 69.0 (42.0-87.0)MRIEPE: 69.0MRIEPE: 41.0 Cerantola etal (2013) [19]MRI+DCE+DWIEPE: 35.0 (19.0-55.0) MRI+DCE+DWIEPE: 90.0 (73.0-98.0) MRI+DCE+DWIEPE: 79.0 (49.0-95.0) MRI+DCE+DWIEPE: 57.0 (41.0-71.0) Hegde et al(2013) [20]MRI+DCE+DWIEPE: 28.0MRI+DCE+DWISVI: 50.0MRI+DCE+DWIEPE: 91.0MRI+DCE+DWISVI: 99.0MRI+DCE+DWIEPE: 50.0MRI+DCE+DWISVI: 83.0MRI+DCE+DWIEPE: 79.0MRI+DCE+DWISVI: 96.0Hole et al(2013) [21]MRI+DWIEPE: 56.3MRI+DWIEPE: 82.2MRI+DWIEPE: 85.4MRI+DWIEPE: 50.4 Isebaert et al(2013) [22]MRI: 25.1 (21.0-29.7)DCE: 22.8 (19.3-26.7)DWI: 36.8 (31.5-42.4)MRI+DCE: 35.6 (31.4-40.1)MRI+DWI: 44.8 (39.4-50.3)DCE+DWI: 43.7 (38.6-48.9)MRI+DCE+DWI: 49.3 (44.2-54.4 )MRI: 94.7 (92.2-96.5)DCE: 94.2 (92.2-95.7)DWI: 93.8 (90.9-95.8)MRI+DCE: 90.3 (87.3-92.7)MRI+DWI: 90.2 (86.8-92.9)DCE+DWI: 89.0 (85.5-91.7)MRI+DCE+DWI: 86.5 (82.6-89.6)MRI: 86.9 (80.2-91.6)DCE: 84.3 (78.7-88.6)DWI: 89.1 (83.5-93.0)MRI+DCE: 83.8 (77.9-88.3)MRI+DWI: 86.7 (80.9-90.9)DCE+DWI: 84.7 (79.1-89.0)MRI+DCE+DWI: 83.7 (77.9-88.2)MRI: 49.9 (44.2-55.5)DCE: 49.0 (43.2-54.8)DWI: 53.5 (48.1-58.7)MRI+DCE: 52.0 (46.3-57.7)MRI+DWI: 55.6 (50.3-60.7)DCE+DWI: 55.0 (49.6-60.3)MRI+DCE+DWI: 56.6 (51.3-61.7)Jeong et al(2013) [23]MRI+DWIEPE: 43.0MRI+DWISVI: 34.9MRI+DWILNM: 14.0MRI+DWIEPE: 84.2MRI+DWISVI: 93.8MRI+DWILNM: 96.9MRI+DWIEPE: 78.6MRI+DWISVI: 62.4MRI+DWILNM: 22.9MRI+DWIEPE: 52.2MRI+DWISVI: 83.1MRI+DWILNM: 94.5 Draft Guideline 27-3 Appendices – March 29, 2016Page 58Johnston et al(2013) [24]MRIEPE: 20.0MRISVI: 0MRIEPE: 80.2MRISVI: 94.2NR-NR-Nepple et al(2013) [25]MRIEPE: 14.0MRISVI: 38.0MRIEPE: 88.0MRISVI: 99.0MRIEPE: 27.0MRISVI: 75.0MRIEPE: 76.0MRISVI: 94.0Pak et al(2013) [26]MRI+DWIEPE: 62.5DWI+MRIEPE: 82.1DWI+MRIEPE: 18.0DWI+MRIEPE: 97.2 Porcaro et al(2013) [27]MRIEPE: 76.0MRIEPE: 78.0MRISVI: 88.0MRIEPE: 95.0MRIEPE: 96.0MRISVI: 98.0MRIEPE: 91.0MRIEPE: 86.0MRISVI: 82.0MRIEPE: 92.0MRIEPE: 92.0MRISVI: 99.0Pugh et al(2013) [28]MRIEPE: 50.9MRIEPE: 83.3MRIEPE: 60.4MRIEPE: 77.2 Renard-Pennaet al (2013)[30]MRI+DCEEPE: 81.3MRI+DCEEPE: 94.1MRI+DCEEPE: 72.2MRI+DCEEPE: 96.4 Roethke et al(2013) [29]MRIT2: 91.8MRIT3: 40.7MRIT4: 33.2MRIEPE: 41.5MRIT2: 41.5MRIT3: 92.9MRIT4: 98.9MRIEPE: 91.8---MRIEPE: 69.0---MRIEPE: 78.0Somford et al(2013) [31]MRI+DCE+DWIEPE: 58.2MRI+DCE+DWIEPE: 89.1MRI+DCE+DWIEPE: 84.1MRI+DCE+DWIEPE: 68.3 Soylu et al(2013) [32]MRISVI: 65 (45.5-84.6)MRI+DWISVI: 78.0 (60.0-94.4)MRI+DCE+DWISVI: 78.0 (60.0-94.4)MRISVI: 90.7 (84.8-96.0)MRI+DWISVI: 96.3 (92.3-99.1)MRI+DCE+DWISVI: 96.3 (92.4-99.1)MRISVI: 60 (40.0-79.3)MRI+DWISVI: 82.0 (64.0-95.8)MRI+DCE+DWISVI: 82.0 (64.7-95.8)MRISVI: 92.5 (87.4-97.1)MRI+DWISVI: 95.4 (91.2-99.1)MRI+DCE+DWISVI: 95.4 (91.2-99.1)Tanaka et al(2013) [33]MRI+DCE+DWIEPE: 60.0MRI+DCE+DWIEPE: 86.0MRI+DCE+DWIEPE: 42.9MRI+DCE+DWIEPE: 92.5 Turkbey et al(2013) [34]MRI+DCE+DWI+MRSEPE: 76.0MRI+DCE+DWI+MRSSVI: 67.0MRI+DCE+DWI+MRSEPE: 95.0MRI+DCE+DWI+MRSSVI: 100MRI+DCE+DWI+MRSEPE: 90.0MRI+DCE+DWI+MRSSVI: 100MRI+DCE+DWI+MRSEPE: 88.0MRI+DCE+DWI+MRSSVI: 98.0Tsao et al(2013) [35]MRI+DCEOCD: 63.1MRI+DCEEPE: 25.0MRI+DCESVI: 35.3MRI+DCEOCD: 41.4MRI+DCEEPE: 70.7MRI+DCESVI: 96.1NR--NR--Kim et al(2012) [36]ER-MRIEPE: 33.3ER-MRISVI: 46.2PC-MRIEPE: 31.3PC-MRISVI: 42.9ER-MRIEPE: 96.6ER-MRISVI: 92.0PC-MRIEPE: 97.5PC-MRISVI: 92.5ER-MRIEPE: 91.7ER-MRISVI: 60.0PC-MRIEPE: 93.8PC-MRISVI: 64.3ER-MRIEPE: 56.9ER-MRISVI: 86.8PC-MRIEPE: 54.2PC-MRISVI: 83.8McClure et al(2012) [51]MRI+DCE+DWI+MRST3: 50.0MRI+DCE+DWI+MRST3: 97.5MRI+DCE+DWI+MRST3: 50.0MRI+DCE+DWI+MRST3: 97.5 Novis et al(2011) [37]MRIT1-T2: 71.5DCET1-T2: 67.2MRST1-T2: 70.4MRIEPE: 50.0MRISVI: 40.0MRIT1-T2: 58.9DCET1-T2: 65.7MRST1-T2: 58.7MRIEPE: 77.6MRISVI: 83.1MRIT1-T2: 76.6DCET1-T2: 79.3MRST1-T2: 78.4MRIEPE: 13.7MRISVI: 15.4MRIT1-T2: 52.4DCET1-T2: 50.6MRST1-T2: 48.2MRIEPE: 95.6MRISVI: 94.7Turkbey et al(2011) [38]MRI: 58.0DCE: 38.0DWI: 53.0MRI: 93.0DCE: 98.0DWI: 95.0MRI: 70.0DCE: 86.0DWI: 73.0MRI: 90.0DCE: 87.0DWI: 89.0 Draft Guideline 27-3 Appendices – March 29, 2016Page 59Abbreviations: ANT-T, anterior index tumours; CI, confidence interval; DCE, dynamic-contrast enhanced imaging for tumor detection; DWI, diffusion-weighted imaging; EPE, extraprostatic extension; ER, endorectalcoil; LNM, lymph node metastasis; MRI, magnetic resonance imaging; MRS, magnetic resonance spectroscopic imaging; NPV, negative predictive value; NR, not reported; OCD, organ-confined disease; PC, pelvic coil;POST-T, posterior index tumors; PPV, positive predictive value; PZ, peripheral zone; SVI, seminal vesicle invasion; TZ, transitional zone.a For a PI-RADS score of ≥4 (Bittencourt et al, 2015); for PI-RADS score of ≥4 to be more conservative (vs. score of 3) (Boesen et al, 2015); for a PI-RADS score of ≥3 (Feng et al, 2015).b Based on 90 patients.c Observer 2 with more than 10 years of experience (Reisaeter et al, 2015); more experienced of the two readers (Lawrence et al, 2014).d For PI-RADS ≥3 and subset of 65 patients with standardized reporting (Schieda et a, 2015).e Tumour ADC value using a cutoff of 1.09 (Kim et al, 2014a) and 0.89 (Woo et al, 2015) × 10/mm for presence of EPE.f Clinically significant cancer is likely to be present (score 4); values are for scores ≥4 (vs. score of 3), according to the European Society of Urogenital Radiology.g For reader A. Kappa between 2 readers was 0.89 per patient analysis.h Per tumor analysis (n=77 tumours).i For the experienced reader.j By prostate side or lobe (right side or left side).k Among 133 patients, there were 50 patients (37.6%) who had MRI+DCE+MRS and 83 patients (62.4%) who had MRI+DCE+DWI+MRS.l 208 lobes.MRS: 16.0MRS: 100MRS: 93.0MRS: 83.0 Lee et al(2010)(b) [39]ER-MRIEPE: 31.8ER-MRISVI: 50.0PC-MRIEPE: 29.6PC-MRISVI: 50.0ER-MRIEPE: 95.5ER-MRISVI: 92.5PC-MRIEPE: 90.0PC-MRISVI: 97.7ER-MRIEPE: 87.5ER-MRISVI: 40.0PC-MRIEPE: 80.0PC-MRISVI: 66.7ER-MRIEPE: 58.3ER-MRISVI: 94.9PC-MRIEPE: 48.7PC-MRISVI: 95.5Turkbey et al(2010) [40]MRIPZ+TZ: 44.0 (37.0-51.0)DCEPZ+TZ: 19.0 (14.0-25.0)MRSPZ+TZ: 12.0 (7.0-18.0)MRIPZ+TZ: 83.0 (81.0-86.0)DCEPZ+TZ: 95.0 (93.0-97.0)MRSPZ+TZ: 97.0 (95.0-98.0)NR--NR-Draft Guideline 27-3 Appendices – March 29, 2016Page 60Table 5. Outcome: Diagnostic Accuracy (Qualitative Summary) (N=4 Studies) Study (Year)Details Junker et al (2015) [81]For 3 T MRI compared with histopathologic findings, the detection of prostate cancer based on receiver operatorcharacteristics were: AUC: 0.90 (95% CI: 0.87-0.94) for MRI alone; AUC: 0.92 (95% CI: 0.88-0.95) for MRI+DWI; andAUC: 0.85 (95% CI: 0.80-0.90) for MRI+DCE.Jung et al (2012) [77]For 1.5 T MRI+ER compared with histopathologic findings in detecting EPE and SVI, the AUC ranged from 0.69 to 0.70for three independent readers.Hwii Ko et al (2011) [78]The number and percentage of patients that were correctly categorized for EPE, SVI, and stage T3 tumours between3 T MRI and pathology were 84 (69.4%), 102 (84.3%), and 89 (73.6%), respectively.Zhang et al (2009) [80]For 1.5 T MRI+ER compared with histopathologic findings in detecting stage T3a or higher, the AUC ranged from 0.71to 0.75 for two independent readers. With the addition of MRS, the AUC ranged from 0.74 to 0.75 for the twoindependent readers. Abbreviations: AUC, area under the curve; CI, confidence interval; DCE, dynamic contrast-enhanced imaging; DWI, diffusion-weighted imaging; EPE, extraprostatic extension; ER, endorectal coil;MRI, magnetic resonance imaging ± DCE, DWI, MRS; MRS, magnetic resonance spectroscopic imaging; SVI, seminal vesicle invasion; T, Tesla. Draft Guideline 27-3 Appendices – March 29, 2016Page 61Outcome: Diagnostic Accuracy (no endorectal coil) Figure 1. Diagnostic Accuracy of 1.5 T MRI ± DCE, DWI, MRS (n=18) Abbreviations: DCE, dynamic contrast-enhanced imaging; DWI, diffusion-weighted imaging; MRI, magnetic resonance imaging ± DCE, DWI, MRS; MRS,magnetic resonance spectroscopic imaging; T, Tesla. Figure 2. Diagnostic Accuracy of 3 T MRI ± DCE, DWI, MRS (n=14) Abbreviations: DCE, dynamic contrast-enhanced imaging; DWI, diffusion-weighted imaging; MRI, magnetic resonance imaging ± DCE, DWI, MRS;MRS, magnetic resonance spectroscopic imaging; T, Tesla.0102030405060708090100 0 10 20 30 40 50 60 70 80 90 100 0102030405060708090100 0 10 20 30 40 50 60 70 80 90 100 1 Specificity (%)1 Specificity (%) Sensitivity(%)Sensitivity(%) Draft Guideline 27-3 Appendices – March 29, 2016Page 62Table 6. Outcome: Change in TNM Stage Classification (N=20 Studies) Study(Year) SSClinical Stage [no. (%)]MRI Stage [no. (%)]DiffResultsSummaryOverallInterpretation ofFindings Counago etal (2015)[45]274 T1a-T2a: 239 (87.2)T1a-T2a: 67 (24.5)-62.7 ↓T1Upstaging(validated in 58%-75%,see Appendix IV, Table2)T2b-c: 30 (11.0)T2b-c: 157 (57.3)46.3 ↑T2 T3-T4: 5 (1.8)T3-T4: 50 (18.2)16.4 ↑T3Counago etal (2014) [5] 150 T1b-T2a: 127 (84.7)T1b-T2a: 28 (18.7)-66.0% ↓T1Upstaging T2b-T2c: 9 (6.0)T2b-T2c: 96 (64.0)58.0% ↑T2 T3-T4: 0 (0)T3-T4: 26 (17.3)17.3% ↑T3Gupta et al(2014) [6] 60 T1: 52 (86.7)T1: 0 (0)-86.7% ↓T1Upstaging T2a/b: 7 (11.7)/T2c: 0 (0) [11.7]T2a/b: 11 (18.3)/T2c: 23 (38.3) [56.6]44.9% ↑T2 T3a: 0 (0)/T3b: 1 (1.6) [1.6]T3a: 21 (35)/T3b: 5 (8.4) [43.4]41.8% ↑T3Lista et al(2014) [12] 85 T1c: 58 (68.2)T1c: 5 (5.9)-62.3% ↓T1Upstaging T2a: 8 (9.4)/T2b: 3 (3.5)/T2c: 13 (15.3) [28.2] T2a: 10 (11.8)/T2b: 8 (9.4)/T2c: 32 (37.6) [58.8] 30.6% ↑T2 T3a: 3 (3.5)/T3b: 0 (0) [3.5]T3a: 16 (18.8)/T3b: 14 (16.5) [35.3]31.8% ↑T3Park et al(2014)(b)[55]282 T1c: 187 (66.3)NRNE -Upstaging T2a: 70 (24.8)/T2b: 16 (5.7)/T2c: 2 (0.7)NRNE T3a: 7 (2.5)/T3b: 0 (0) [2.5]T3a: 96 (34.0)/T3b: 9 (3.2) [37.2]34.7% ↑T3Armitage etal (2013)[18]69 T1-T2a: 4 (5.8)NRNE -Upstaging T2b/c: 58 (84.1)NRNE T3-T4: 7 (10.1)T3: 13 (37.1)27.0% ↑T3Cerantola etal (2013)[19]60 ~T1: 24 (40.0)T1: 0 (0)-40.0% ↓T1Upstaging(validated in 62%, seeAppendix IV, Table 2)~T2: 34 (56.7)T2a: 23 (38.3)/T2b: 11 (18.3)/T2c: 12 (20.0) [76.6] 19.9% ↑T2 ~T3: 2 (3.3)T3a: 12 (20.0)16.7% ↑T3 T4: 0 (0)T4: 2 (3.3)3.3% ↑T4Hegde et al(2013) [20] 118 T1c: 91 (77.1)T1: 0 (0)-77.1% ↓T1Upstaging(validated, p = 0.0012,see Appendix IV, Table2)T2a: 18 (15.3)/T2b: 6 (5.1)/T2c: 3 (2.5) [22.9] T2: 102 (86.4)63.5% ↑T2 T3: 0 (0)T3: 16 (13.6)13.6% ↑T3 Draft Guideline 27-3 Appendices – March 29, 2016Page 63Hole et al(2013) [21] 209 T1c: 96 (45.9)T1: 0 (0)-45.9% ↓T1Upstaging(validated for 85%, seeAppendix IV, Table 2)T2a/T2b: 53 (25.4)/T2c: 22 (10.5) [35.9]T2a/b: 52 (24.9)/T2c: 55 (26.3) [51.2]15.3% ↑T2 T3: 38 (18.2)T3a: 74 (35.4)/T3b: 13 (6.2) [41.6]23.4% ↑T3 T4: 0 (0)T4: 3 (1.4)1.4% ↑T4Johnston etal (2013)[24]568 T1-T2a: 198 (34.9)NRNE -T2b-T2c: 303 (53.3)NRNE T3-T45: 67 (11.8)T3a: 113 (19.9)/T3b: 31 (5.5)NE -Porcaro et al(2013) [27] 154 T1c: 42 (27.3)T1: 0 (0)-27.3% ↓T1Upstaging T2: 112 (72.7)T2: 100 (64.9)-7.8% ↓T2 T3: 0 (0)T3a: 37 (24.0)/T3b: 17 (11.0) [35.0]35.0% ↑T3Pugh et al(2013) [28] 171 T1c: 87 (50.9)--28.1% ↓T1UpstagingT2a: 43 (25.1)/T2b: 36 (21.1)/T2c: 5 (2.9)[49.1]≤T2: 123 (71.9)22.8% ↑T2 T3: 0 (0)T3a-b: 48 (28.1)28.1% ↑T3Renard-Penna et al(2013) [30] 101 T1c: 75 (74.3)T1: 0 (0)-74.3% ↓T1Upstaging T2a: 8 (7.9)/T2b: 7 (6.9) [14.8]T2: 83 (82.2)67.4% ↑T2 T3a: 6 (5.9)/ T3b: 5 (5.0) [10.9]T3a: 13 (12.9)/T2b: 0 (0) [12.9]2.0% ↑T3Somford etal (2013)[31]183 T1: 95 (51.9)T1: 0 (0)-51.9% ↓T1Upstaging T2: 67 (36.6)T2: 120 (65.6)29.0% ↑T2 T3: 21 (11.5)T3: 63 (34.4)22.9% ↑T3Tanaka et al(2013) [33] 67 T1: 0 (0)T1: 0 (0)0% -DownstagingT2a: 28 (41.8)/T2b: 3 (4.5)/T2c: 20 (29.9)[76.2]T2: 53 (79.1)2.9% ↑T2 T3a: 16 (23.9)T3a: 14 (20.9)-3.0% ↓T3Tsao et al(2013) [35] 94 T1: 0 (0)T1: 0 (0)0% -Upstaging(validated in 11%-71%,see Appendix IV, Table2)≤ T2: 94 (100)T2: 58 (61.7)-38.3% ↓T2 T3: 0 (0)T3a: 27 (28.7)/T3b: 9 (9.6) [38.3]38.3% ↑T3Panebiancoet al (2012)[53]105 T1c or T2a: 105 (100)T2: 73 (69.5)-30.5% ↓T1c/2Upstaging(validated in 28%, seeAppendix IV, Table 2)T3: 0 (0)T3: 32 (30.5)30.5% ↑T3 Draft Guideline 27-3 Appendices – March 29, 2016Page 64Ploussard etal (2011)[54]96 T1: ~84 (87.5)T1 or T2: 68 (70.8)-29.2% ↓T1/2Upstaging T2: 12 (12.5)-NE T3: 0 (0)T3: 28 (29.2)29.2% ↑T3Brown et al(2009) [56] 62 T1c: 31 (54.4)T1: 0 (0)-54.4% ↓T1Upstaging(validated in 38%-82%,see Appendix IV, Table2)T2: 26 (50.0)T2: 47 (75.8)25.8% ↑T2 T3: 0 (0)T3: 15 (24.2)24.2% ↑T3Cirillo et al(2008) [57] 143 T1: 18 (12.6)T1: 3 (2.1)-10.5% ↓T1Upstaging T2: 113 (79.0)T2: 89 (62.2)-16.8% ↓T2 T3: 12 (8.4)T3: 49 (34.3)25.9% ↑T3 T4: 0 (0)T4: 2 (1.4)1.4% ↑T4 Abbreviations: DCE, dynamic contrast-enhanced imaging; diff, difference; DRE, digital rectal examination; DWI, diffusion-weighted imaging; EPE, extraprostatic extension; MRI, magnetic resonance imaging ± DCE, DWI, MRS; MRS,magnetic resonance spectroscopic imaging; NE, not estimable; NR, not reported; SS, sample size.a Staging according to the American Joint Committee on Cancer. Totals for a given stage are depicted by square brackets as percentages.b Absolute within stage difference defined as: MRI stage minus clinical stage (baseline). A negative value indicates a decrease in the number or proportion of patients within a given stage category whereas a positive value indicates anincrease in the number or proportion of patients within a given stage category. Change across stage categories is not specified.c Reported for T stage overall.d Subset of 35 patients had MRI results (Armitage et al, 2013).e T1 given as “normal”, T2 given as “palpable”, and T3 given as “EPE” from DRE, as described in the original study.f No tumor was identified at MRI for 10 patients and MRI was indeterminate for two patients.g Patients categorized for clinical stage are part of the D’Amico risk classification reported in the original paper (e.g. low risk: T1-T2a, Gleason score ≤6, prostate-specific antigen level <10 ng/mL).h T3a-b represents “EPE” from the original paper. Remainder of patients were assumed to be ≤T2 stage for MRI. Calculation of difference assumes: MRI ≤T2 stage minus clinical T2 stage (22.8%) and MRI ≤T2 stage minus clinical T2stage minus clinical T1 stage (28.1%).i Five patients unaccounted for in MRI results, therefore overall findings are uncertain.j ≤T2 patients are categorized according to “clinically localized” as described in the study.k Group A assigned to T2 and Group B assigned to T3 for MRI staging. Group A defined in the original paper as patients submitted to bilateral nerve-sparing radical prostatectomy. Group B defined in the original paper as patientssubmitted to unilateral nerve-sparing or non-nerve sparing radical prostatectomy.l T1 or T2 in MRI subtracted from combined T1 and T2 in clinical stage (29.2%)m Clinical stage only available for 57 patients. Note 1. ~indicates that either stage or number was estimated or assumed from limited data in the original paper. Draft Guideline 27-3 Appendices – March 29, 2016Page 65Table 7. Outcome: Change in Risk Stratification Category (Qualitative Summary) (N=2 Studies) Study (Year)Details Counago et al (2015) [45] Risk group changes were as follows: pre-MRI as 34.7% low risk, 46.4% intermediate risk,and 19.0% high risk. Post-MRI as 11.7% low risk, 59.5% intermediate risk, and 28.8% highrisk. Overall, there were fewer individuals categorized as low risk and more individualscategorized as intermediate or high risk.Counago et al (2014) [5] Risk group change in 35 of 103 (33.9%) patients with a provisional treatment plan. Therewere 21 (20.1%) patients who were changed from low risk to intermediate risk, one(0.9%) patient that was changed from low risk to high risk, five (3.8%) patients that werechanged from intermediate risk to intermediate-high risk, and eight (7.6%) patients thatwere changed from intermediate risk to high risk. Abbreviations: DCE, dynamic contrast-enhanced imaging; DWI, diffusion-weighted imaging; MRI, magnetic resonance imaging ± DCE, DWI, MRS; MRS,magnetic resonance spectroscopic imaging. Draft Guideline 27-3 Appendices – March 29, 2016Page 66Table 8. Outcome: Change in Treatment Plan (N=6 Studies) Study(Year) MRITreatment Plan Diff Results Overall CorrectnessBefore MRI[no. (%)]After MRI[no. (%)] Counagoet al(2015)[45]3 TMRI+DCE+DWIHigh doses:179 (65.3) ≥interm+high risk ptsHT1: 92 (33.6)HT2: 125 (45.6)High doses:242 (88.3) ≥interm+high risk ptsHT1: 116 (42.3)HT2: 171 (62.4)23.0% 8.7%16.8%↑ therapyMoreintensetherapy“less disagreementwith therapy changesbased on imagingcompared to clinicalstaging therapydecision-making”Rud et al(2015)[41]1.5 TMRI+DWINRIntervention arm:59/222 pts had analtered procedure onone or both sides[cT1: 30 (51%), cT2:29 (49%), rT3: 49(83%)]26.6% Change Authorsstated:moreradicalexcisionfor allsurgicalchangesNR Counagoet al(2014)[5]3 TMRI+DCE+DWILow riskCTV: prostate; doses:78 Gy; HT: none Low riskCTV: prostate; doses:78 Gy; HT: none Interm riskCTV: prostate + SSVV;doses: 80 Gy; HT:none Interm riskCTV: prostate + SSVV;doses: 80 Gy; HT:noneInterm risk (21 pts)CTV: prostate + SSVV;doses: 80 Gy; HT:none High risk (1 pt)CTV: prostate + SSVV;doses: 80 Gy; HT x 24mo Interm-high risk (5pts)CTV: prostate + SSVV;doses: 80 Gy; HT x 6mo High risk (8 pts)CTV: prostate + SSVV;doses: 80 Gy; HT x 24mo20.1%