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THE RISK INDICATOR® AND THE FUTURE RISK OF HAVING A BIOPSY DETECTABLE PROSTATE CANCER
807 AN OPTIMISED METHOD FOR FIXATION OF PROSTATE CORE NEEDLE BIOPSY SPECIMENS
808 SATURATION VS. EXTENDED (EPBX) TECHNIQUE (10 CORES) AS AN INITIAL PROSTATE BIOPSY (PBX) STRATEGY: RESULTS OF A PROSPECTIVE RANDOMISED COMPARATIVE STUDY
Pryalukhin A.E.1, Topuzov M.E.1, Urbansky A.I.2 1
Mechnikov St. Petersburg State Medical Academy, Dept. of Urology, Saint Petersburg, Russia, Federal State Institution Russian Research Centre for Radiology and Surgical Technologies, Dept. of Pathomorphology, Saint Petersburg, Russia
2
Introduction & Objectives: The probability of prostate cancer detecting is related to the amount of tissue represented. During conventional processing of biopsy specimens, the shape of the VSHFLPHQVLVRIWHQFKDQJHGEHFDXVHRIᚏ[DWLRQᚐRDWLQJIUHHLQIRUPDOLQᚏOOHGFRQWDLQHUV:KHQ a non-cylindrical prostate biopsy specimen is embedded in a block, less tissue is evaluated EHFDXVHLWLVGLᚑFXOWWRHPEHGWKHVSHFLPHQLQDVLQJOHSODQH,IWKHVSHFLPHQVWUHWFKHGWKHUHDO extension of pathological tissue structures can not be measured. The authors suppose that, for optimal tissue representation, the specimens should preserve their regular cylindrical shape and should not be stretched. Our objective was to invent and to test a new pre-embedding method by using a new glass cassette. Material & Methods: )RUWKDWSXUSRVHPHQZLWKSURVWDWHVSHFLᚏFDQWLJHQOHYHO QJPO and non-remarkable digital rectal examination underwent transrectal ultrasonography-guided 12core prostate biopsy due to clinical suspicious of neoplasia.The patients were randomized into JURXSVRI,QWKHᚏUVWJURXSRISDWLHQWVDOOELRSV\VSHFLPHQVZHUHFRQYHQWLRQDOO\VXEPLWWHG ᚐRDWLQJ IUHH LQ IRUPDOLQᚏOOHG FRQWDLQHUV,Q WKH VHFRQG JURXS DOO ELRSV\ VSHFLPHQV ZHUH SUH WUHDWHGDFFRUGLQJWRWKHRSWLPL]HGSUHHPEHGGLQJSURFHGXUH%HIRUHᚏ[DWLRQELRSV\VSHFLPHQV ZHUHSXWLQWRDJODVVFDVVHWWHZKLFKFRQWDLQHGVHSDUDWHJURRYHV7KHᚏUVWJURRYHZDVPDUNHG and the specimens were put into the grooves according to a conventional scheme. The depth DQGZLGWKRIDJURRYHFRQIRUPHGWRWKHELRSV\QHHGOHGLDPHWHU WKHOHQJWKFRQIRUPHGWRWKHVL]H of specimens (19 mm). The glass cassette with the specimens in the grooves was covered with a WKLQQ\ORQVSRQJHDQGDJODVVSODWH7KHZKROHFRQVWUXFWLRQZDVPHFKDQLFDOO\ᚏ[HGDQGGLSSHG LQIRUPDOLQ:HDQDO\]HGVHFWLRQVRIHDFKVSHFLPHQ
Brausi M.A.1, Castagnetti G.2, Giliberto G.L.1, Viola M.1, Gavioli M.1, La Vecchia S.1, Olmi R.1 1 AUSL Modena, Dept. of Urology, Modena, Italy, 2AUSL Modena, Dept. of Urology, Sassuolo, Italy
Introduction & Objectives: Saturation technique has been suggested as an initial PBx strategy for the diagnosis of prostate cancer in patients with an elevated PSA with no improvement in cancer detection. However no randomised, prospective studies are available till now supporting this. The objectives of our study were to evaluate in a prospective, randomized setting if saturation technique of PBx could detect more cancers than EPBx, to observe and compare the complication rates and costs of the 2 techniques. Material & Methods: In 2006, 1282 PBx have been performed in 2 urological centres. After review board approval and patients informed consent 66 pts. with an elevated PSA were UDQGRPLVHGWRUHFHLYHG6DWXUDWLRQ%[RU(3%[DVWKHLQLWLDOGLDJQRVWLFSURFHGXUHSDWLHQWV UHFHLYHGVDWXUDWLRQELRSV\ *URXS$ DQGSWV(3%[ *URXS% 7UDQVUHFWDOURXWHZDV XVHG LQ ERWK JURXSV )OXRUFKLQRORQHV GD\ EHIRUH DQG GD\V DIWHU ELRSV\ ZDV DOZD\V prescribed. Saturation Bx was performed under local anesthesia or sedation in a day hospital VHWWLQJ KRXUV DFFRUGLQJWRWKHVWDQGDUGWHFKQLTXHZKLOH(3%[ZHUHREWDLQHGLQWKHRᚑFH without anesthesia according to the technique described by Gore et al. The number of cores REWDLQHGLQ*URXS$YDULHGIURPWR PHDQ DQGLQ*URXS%7KHPHDQSDWLHQW DJHLQ*URXS$ZDVYVLQ*URXS%0HDQ3VDLQ*URXS$ZDV UDQJH QJPO YV UDQJH QJPO LQ *URXS % 0HDQ SURVWDWH YROXPH FF LQ *URXS $ UDQJHFF YVFF UDQJHFF
Results: 7KH DXWKRUV FRPSDUHG WKH LQᚐXHQFH RI D FRQYHQWLRQDO DQG DQ RSWLPL]HG VXEPLWWLQJ method of prostate core needle biopsy specimens on the frequency of cancer detected.In the ᚏUVW DQG WKH VHFRQG JURXSV SURVWDWH FDQFHU ZDV GHWHFWHG LQ DQG RI SDWLHQWV UHVSHFWLYHO\7KHQHZPHWKRGDOVROHGWRDQLQFUHDVHRIVPDOOWXPRXUIRFL GLPHQVLRQV PP GHWHFWLRQ LQWKHVHFRQGJURXSWKHDQDO\VLVGHWHFWHGVPDOOWXPRXUIRFLLQRIVSHFLPHQV WKH UHVXOW LQ WKH ᚏUVW JURXS ZDV 'LᚎHUHQFHV ZHUH UHJDUGHG DV VWDWLVWLFDOO\ VLJQLᚏFDQW (P<0.05).
Results: ,Q *URXS $ SWV KDG FDQFHU YV LQ *URXS % 0HDQ QXPEHURISRVLWLYHELRSVLHV *URXS$ UDQJH *URXS% UDQJH *UDGH *URXS $ *OHDVRQVFRUH SWV *URXS% *OHDVRQVFRUH SWV 8 = 1. Complications: Prostatitis with fever developed in 1 patient in each group and was treated with intensive antibiotic therapy. 1 pt. required hospitalisation. Rectal bleeding was common but only 2 men in Group A and 1 in Group B required intensive treatment (tampon) DQGVKRUWKRVSLWDOLVDWLRQ&RVWV 6DWXUDWLRQELRSV\LQDGD\VHWWLQJFRVWHG (XURYV IRUWKHRᚑFHEDVHG(3%[$PRQH\JDLQRISHU(3%[FDQEHREWDLQHG
Conclusions: The new pre-embedding method resulted in cylindrical, non-stretched core ELRSV\ VSHFLPHQV DIWHU ᚏ[DWLRQ 7KH SURVWDWH FDQFHU GHWHFWLRQ UDLVHG LQFOXGLQJ WKH GHWHFWLRQ RI VPDOO WXPRXU IRFL GLPHQVLRQV PP RI SURVWDWH FDQFHU 7KH RSWLPL]LQJ RI VSHFLPHQ VKDSHVLJQLᚏFDQWO\LPSURYHVWKHKLVWRORJLF\LHOGSHUVHFWLRQOHYHODQGDOORZVPHDVXULQJWKHUHDO extension of pathological tissue structures.
Conclusions: 7KHUHVXOWVRIRXUVWXG\VKRZHGWKDWVDWXUDWLRQELRSV\ZLWKFRUHVGLG QRWGHWHFWPRUHSURVWDWHFDQFHUVWKDQ(3%[LWLVQRWFRVWHᚎHFWLYH LIDSSOLHGLQDGD\VHWWLQJ and should not be applied routinely as initial diagnostic strategy.
809 FALSE-NEGATIVE PROSTATE BIOPSY FOR ADENOCARCINOMA: INCIDENCE AND FOLLOW-UP IN A HIGH-RISK SCREENED POPULATION Wolters T.1, Schröder F.H.2, Van Den Bergh R.C.N.2, Roobol M.J.2, Bangma C.H.2, Leenders G.J.L.H., European Randomized Study of Screening for Prostate Cancer 1
810 THE RISK INDICATOR® AND THE FUTURE RISK OF HAVING A BIOPSY DETECTABLE PROSTATE CANCER Roobol M.J.1, Kranse R.2, Schröder F.H.1 1 Erasmus Medical Centre, Dept. of Urology, Rotterdam, The Netherlands, 2Comprehensive Cancer Centre, Rotterdam, Rotterdam, The Netherlands
2
Erasmus Medical Centre, Dept. of Urology and Pathology, Rotterdam, The Netherlands, Erasmus Medical Centre, Dept. of Urology, Rotterdam, The Netherlands, Erasmus Medical Centre, Dept. of Pathology, Rotterdam, The Netherlands, Introduction & Objectives: In the literature, false-negative pathological examination has been described. This holds true for prostate biopsy as well. The magnitude of this phenomenon and its implications for the patient are unknown. The objective of this study was to assess the prevalence and clinical consequences of false-negative prostate biopsy in a high-risk population for having a prior missed prostate cancer (PC) lesion. Material & Methods: All men included were participants of the European Randomized Study of Screening for Prostate Cancer, Rotterdam section, and diagnosed with PC during screening after a previous negative biopsy 4 years earlier. A ODWHUDOL]HGVH[WDQWELRSV\ZDVLQGLFDWHGE\D36$! QJPO$XURJHQLWDOSDWKRORJLVWUHYLHZHGWKHQHJDWLYHELRSVLHV Gleason score (GS) and number of positive cores (NP) of the missed lesions were compared to those of the PC detected four years later. In addition, clinical tumor stage (cT) and PSA value were compared. Results: A total of 121 biopsy specimens were reviewed and 12 (9.9%) PC cases were detected. GS, NP, cT and PSA values at time of the missed lesions and four years later during PC detection are shown in the table. Missed lesion PSA (ng/ml) Clinical tumor stage
Gleason score Number of positive cores
PC detected 4 years later mean median T1c T2a T2c 7D 7F 1 2 4 5
5.0 4.1 10
1 1 11 1 8 4
8.1 7.0 7 1 1 10 2 7 1 1
36$ZDVVLJQLᚏFDQWO\KLJKHUDWWLPHRI3&GHWHFWLRQ :LOFR[RQWHVWS &RQVLGHULQJGLᚎHUHQFHVLQ*613DQGF7 DIWHU\HDUVOHVVIDYRXUDEOHIHDWXUHVZHUHIRXQGLQFDVHV LQQ RQO\WKH13LQFUHDVHGLQQ RQO\F7LQFUHDVHG DQGLQQ 13DQG*6LQFUHDVHG ,QWKHUHPDLQLQJFDVHVQRGLᚎHUHQFHVZHUHIRXQG Q RUPRUHIDYRXUDEOHIHDWXUHV were found (in n=2 only NP decreased and in n=1 cT decreased). Conclusions: Primarily, it should be noted that the false-negative rate of 9.9% found in this study is not indicative for the general population, but an over-estimation. All men were diagnosed with PC four years later and were therefore at increased risk of a prior missed lesion. Secondly, the review performed in this study was biased by the knowledge that every man was diagnosed with PC 4 years later. Although general features become less favourable in most men with a prior missed lesion of PC, the majority still seems to be in a curable stage. An explanation for this could be the preclinical phase in which the screen-detected PC is found, with a mean lead time estimated to be around 10 years in RXUSRSXODWLRQ7KLVPD\LPSO\WKDWWKHHᚎHFWVRIPLVVLQJD3&OHVLRQ\HDUVHDUOLHUDUHQRWQHFHVVDULO\QHJDWLYHIRU patient outcome in this screened cohort. However, as follow-up is not long enough to establish whether the PC detected DIWHUPLVVLQJDOHVLRQZDVFOLQLFDOO\VLJQLᚏFDQWFXUDEOHLQFXUDEOHRUHYHQIDWDOWKHWUXHLPSOLFDWLRQVRIPLVVLQJD3& lesion on biopsy specimens remain unclear.
Introduction & Objectives: 5HFHQWO\ ZH GHYHORSHG D PXOWLVWHS ULVN FDOFXODWRU >@ 7KH ᚏUVW VWHSV (based on data of 6,288 men screened at the 1st screening round of the Dutch part of the European Randomised study of Screening for prostate cancer (ERSPC)are meant for lay men and can be used to estimate the risk of having a biopsy detectable PC ((P)posb) using basal information such as age DQGIDPLO\KLVWRU\6WHSHQDEOHVXURORJLVWVWRHVWLPDWHDPDQಬVFXUUHQW 3 SRVEDQGLVEDVHGRQWKH screening results (serum PSA level, result of DRE and TRUS, prostate volume and biopsy outcome) of PHQ+HUHZHUHODWHWKLVFXUUHQWULVNWRVFUHHQLQJUHVXOWV\UVODWHU Material & Methods: :LWKWKHULVNFDOFXODWRUZHFDOFXODWHGWKH3 SRVE RIPHQZLWKDQLQLWLDO36$ OHYHORI QJPO7KHVHPHQZHUHQRWELRSVLHGEXWUHLQYLWHGIRUDQGVFUHHQLQJYLVLW\UVODWHU 6WUDWLᚏHG3 SRVE ZHUHUHODWHGWRQXPEHURIPHQZLWK36$! QJPODQG3&GHWHFWLRQ\UVODWHU and the predictive value of the calculated P(posb) on PC detection 4 yrs later was assessed by logistic regression analysis. Results: $WQGVFUHHQLQJPHQ RI KDGD36$! QJPO PHQELRSVLHG DQG 3&ZHUHGHWHFWHG 339 &'5 7KHᚏJXUHVKRZVWKHSRVLWLYHFRUUHODWLRQRI3 SRVE with an elevated PSA level and PC detection 4 yrs later. Men with a baseline P(posb) < 5% ( 72% of WRWDOFRKRUW KDYHDFKDQFHRIKDYLQJD36$! QJPO DQGDFKDQFH of a biopsy detectable PC 4 yrs later (26/26+2285). The odds ratio of P(posb) was 1.2 (univariate, p < 0.001). Correcting for PSA,DRE,TRUS and prostate volume at 2nd screening the P(posb) remained a VLJQSUHGLFWRU RGGVUDWLRS Conclusions: The risk calculator® (http://www.uroweb.org/) is capable of independently predicting PC risk at least 4 yrs before diagnosis. Data show that the majority of asymptomatic men in the age range ZLWKD36$ QJPOKDYHDYHU\ORZ3 SRVE ZKLFKUHPDLQVFRQVWDQWGXULQJWKHDWOHDVW IROORZLQJ \UV 7KLV LV FRQVLVWHQW ZLWK GDWD RI &RQQROO\ HW DO>@ WKDW VKRZ WKDW 3& DQG GHDWK IURP 3& is rare in men with low PSA levels. The risk calculator® can be of help in the awareness of the likelihood of having a diagnosis of PC and in determining an individualized screening interval with the goal to reduce PSA testing and prostate biopsies that lead to unnecessary anxiety and costs. 1. Kranse et al. submitted 2. Conolly et al. AUA 2007,#1890
Eur Urol Suppl 2008;7(3):273
808 SATURATION VS. EXTENDED (EPBX) TECHNIQUE (10 CORES) AS AN INITIAL PROSTATE BIOPSY (PBX) STRATEGY: RESULTS OF A PROSPECTIVE RANDOMISED COMPARATIVE STUDY
Pryalukhin A.E.1, Topuzov M.E.1, Urbansky A.I.2 1
Mechnikov St. Petersburg State Medical Academy, Dept. of Urology, Saint Petersburg, Russia, Federal State Institution Russian Research Centre for Radiology and Surgical Technologies, Dept. of Pathomorphology, Saint Petersburg, Russia
2
Introduction & Objectives: The probability of prostate cancer detecting is related to the amount of tissue represented. During conventional processing of biopsy specimens, the shape of the VSHFLPHQVLVRIWHQFKDQJHGEHFDXVHRIᚏ[DWLRQᚐRDWLQJIUHHLQIRUPDOLQᚏOOHGFRQWDLQHUV:KHQ a non-cylindrical prostate biopsy specimen is embedded in a block, less tissue is evaluated EHFDXVHLWLVGLᚑFXOWWRHPEHGWKHVSHFLPHQLQDVLQJOHSODQH,IWKHVSHFLPHQVWUHWFKHGWKHUHDO extension of pathological tissue structures can not be measured. The authors suppose that, for optimal tissue representation, the specimens should preserve their regular cylindrical shape and should not be stretched. Our objective was to invent and to test a new pre-embedding method by using a new glass cassette. Material & Methods: )RUWKDWSXUSRVHPHQZLWKSURVWDWHVSHFLᚏFDQWLJHQOHYHO QJPO and non-remarkable digital rectal examination underwent transrectal ultrasonography-guided 12core prostate biopsy due to clinical suspicious of neoplasia.The patients were randomized into JURXSVRI,QWKHᚏUVWJURXSRISDWLHQWVDOOELRSV\VSHFLPHQVZHUHFRQYHQWLRQDOO\VXEPLWWHG ᚐRDWLQJ IUHH LQ IRUPDOLQᚏOOHG FRQWDLQHUV,Q WKH VHFRQG JURXS DOO ELRSV\ VSHFLPHQV ZHUH SUH WUHDWHGDFFRUGLQJWRWKHRSWLPL]HGSUHHPEHGGLQJSURFHGXUH%HIRUHᚏ[DWLRQELRSV\VSHFLPHQV ZHUHSXWLQWRDJODVVFDVVHWWHZKLFKFRQWDLQHGVHSDUDWHJURRYHV7KHᚏUVWJURRYHZDVPDUNHG and the specimens were put into the grooves according to a conventional scheme. The depth DQGZLGWKRIDJURRYHFRQIRUPHGWRWKHELRSV\QHHGOHGLDPHWHU WKHOHQJWKFRQIRUPHGWRWKHVL]H of specimens (19 mm). The glass cassette with the specimens in the grooves was covered with a WKLQQ\ORQVSRQJHDQGDJODVVSODWH7KHZKROHFRQVWUXFWLRQZDVPHFKDQLFDOO\ᚏ[HGDQGGLSSHG LQIRUPDOLQ:HDQDO\]HGVHFWLRQVRIHDFKVSHFLPHQ
Brausi M.A.1, Castagnetti G.2, Giliberto G.L.1, Viola M.1, Gavioli M.1, La Vecchia S.1, Olmi R.1 1 AUSL Modena, Dept. of Urology, Modena, Italy, 2AUSL Modena, Dept. of Urology, Sassuolo, Italy
Introduction & Objectives: Saturation technique has been suggested as an initial PBx strategy for the diagnosis of prostate cancer in patients with an elevated PSA with no improvement in cancer detection. However no randomised, prospective studies are available till now supporting this. The objectives of our study were to evaluate in a prospective, randomized setting if saturation technique of PBx could detect more cancers than EPBx, to observe and compare the complication rates and costs of the 2 techniques. Material & Methods: In 2006, 1282 PBx have been performed in 2 urological centres. After review board approval and patients informed consent 66 pts. with an elevated PSA were UDQGRPLVHGWRUHFHLYHG6DWXUDWLRQ%[RU(3%[DVWKHLQLWLDOGLDJQRVWLFSURFHGXUHSDWLHQWV UHFHLYHGVDWXUDWLRQELRSV\ *URXS$ DQGSWV(3%[ *URXS% 7UDQVUHFWDOURXWHZDV XVHG LQ ERWK JURXSV )OXRUFKLQRORQHV GD\ EHIRUH DQG GD\V DIWHU ELRSV\ ZDV DOZD\V prescribed. Saturation Bx was performed under local anesthesia or sedation in a day hospital VHWWLQJ KRXUV DFFRUGLQJWRWKHVWDQGDUGWHFKQLTXHZKLOH(3%[ZHUHREWDLQHGLQWKHRᚑFH without anesthesia according to the technique described by Gore et al. The number of cores REWDLQHGLQ*URXS$YDULHGIURPWR PHDQ DQGLQ*URXS%7KHPHDQSDWLHQW DJHLQ*URXS$ZDVYVLQ*URXS%0HDQ3VDLQ*URXS$ZDV UDQJH QJPO YV UDQJH QJPO LQ *URXS % 0HDQ SURVWDWH YROXPH FF LQ *URXS $ UDQJHFF YVFF UDQJHFF
Results: 7KH DXWKRUV FRPSDUHG WKH LQᚐXHQFH RI D FRQYHQWLRQDO DQG DQ RSWLPL]HG VXEPLWWLQJ method of prostate core needle biopsy specimens on the frequency of cancer detected.In the ᚏUVW DQG WKH VHFRQG JURXSV SURVWDWH FDQFHU ZDV GHWHFWHG LQ DQG RI SDWLHQWV UHVSHFWLYHO\7KHQHZPHWKRGDOVROHGWRDQLQFUHDVHRIVPDOOWXPRXUIRFL GLPHQVLRQV PP GHWHFWLRQ LQWKHVHFRQGJURXSWKHDQDO\VLVGHWHFWHGVPDOOWXPRXUIRFLLQRIVSHFLPHQV WKH UHVXOW LQ WKH ᚏUVW JURXS ZDV 'LᚎHUHQFHV ZHUH UHJDUGHG DV VWDWLVWLFDOO\ VLJQLᚏFDQW (P<0.05).
Results: ,Q *URXS $ SWV KDG FDQFHU YV LQ *URXS % 0HDQ QXPEHURISRVLWLYHELRSVLHV *URXS$ UDQJH *URXS% UDQJH *UDGH *URXS $ *OHDVRQVFRUH SWV *URXS% *OHDVRQVFRUH SWV 8 = 1. Complications: Prostatitis with fever developed in 1 patient in each group and was treated with intensive antibiotic therapy. 1 pt. required hospitalisation. Rectal bleeding was common but only 2 men in Group A and 1 in Group B required intensive treatment (tampon) DQGVKRUWKRVSLWDOLVDWLRQ&RVWV 6DWXUDWLRQELRSV\LQDGD\VHWWLQJFRVWHG (XURYV IRUWKHRᚑFHEDVHG(3%[$PRQH\JDLQRISHU(3%[FDQEHREWDLQHG
Conclusions: The new pre-embedding method resulted in cylindrical, non-stretched core ELRSV\ VSHFLPHQV DIWHU ᚏ[DWLRQ 7KH SURVWDWH FDQFHU GHWHFWLRQ UDLVHG LQFOXGLQJ WKH GHWHFWLRQ RI VPDOO WXPRXU IRFL GLPHQVLRQV PP RI SURVWDWH FDQFHU 7KH RSWLPL]LQJ RI VSHFLPHQ VKDSHVLJQLᚏFDQWO\LPSURYHVWKHKLVWRORJLF\LHOGSHUVHFWLRQOHYHODQGDOORZVPHDVXULQJWKHUHDO extension of pathological tissue structures.
Conclusions: 7KHUHVXOWVRIRXUVWXG\VKRZHGWKDWVDWXUDWLRQELRSV\ZLWKFRUHVGLG QRWGHWHFWPRUHSURVWDWHFDQFHUVWKDQ(3%[LWLVQRWFRVWHᚎHFWLYH LIDSSOLHGLQDGD\VHWWLQJ and should not be applied routinely as initial diagnostic strategy.
809 FALSE-NEGATIVE PROSTATE BIOPSY FOR ADENOCARCINOMA: INCIDENCE AND FOLLOW-UP IN A HIGH-RISK SCREENED POPULATION Wolters T.1, Schröder F.H.2, Van Den Bergh R.C.N.2, Roobol M.J.2, Bangma C.H.2, Leenders G.J.L.H., European Randomized Study of Screening for Prostate Cancer 1
810 THE RISK INDICATOR® AND THE FUTURE RISK OF HAVING A BIOPSY DETECTABLE PROSTATE CANCER Roobol M.J.1, Kranse R.2, Schröder F.H.1 1 Erasmus Medical Centre, Dept. of Urology, Rotterdam, The Netherlands, 2Comprehensive Cancer Centre, Rotterdam, Rotterdam, The Netherlands
2
Erasmus Medical Centre, Dept. of Urology and Pathology, Rotterdam, The Netherlands, Erasmus Medical Centre, Dept. of Urology, Rotterdam, The Netherlands, Erasmus Medical Centre, Dept. of Pathology, Rotterdam, The Netherlands, Introduction & Objectives: In the literature, false-negative pathological examination has been described. This holds true for prostate biopsy as well. The magnitude of this phenomenon and its implications for the patient are unknown. The objective of this study was to assess the prevalence and clinical consequences of false-negative prostate biopsy in a high-risk population for having a prior missed prostate cancer (PC) lesion. Material & Methods: All men included were participants of the European Randomized Study of Screening for Prostate Cancer, Rotterdam section, and diagnosed with PC during screening after a previous negative biopsy 4 years earlier. A ODWHUDOL]HGVH[WDQWELRSV\ZDVLQGLFDWHGE\D36$! QJPO$XURJHQLWDOSDWKRORJLVWUHYLHZHGWKHQHJDWLYHELRSVLHV Gleason score (GS) and number of positive cores (NP) of the missed lesions were compared to those of the PC detected four years later. In addition, clinical tumor stage (cT) and PSA value were compared. Results: A total of 121 biopsy specimens were reviewed and 12 (9.9%) PC cases were detected. GS, NP, cT and PSA values at time of the missed lesions and four years later during PC detection are shown in the table. Missed lesion PSA (ng/ml) Clinical tumor stage
Gleason score Number of positive cores
PC detected 4 years later mean median T1c T2a T2c 7D 7F 1 2 4 5
5.0 4.1 10
1 1 11 1 8 4
8.1 7.0 7 1 1 10 2 7 1 1
36$ZDVVLJQLᚏFDQWO\KLJKHUDWWLPHRI3&GHWHFWLRQ :LOFR[RQWHVWS &RQVLGHULQJGLᚎHUHQFHVLQ*613DQGF7 DIWHU\HDUVOHVVIDYRXUDEOHIHDWXUHVZHUHIRXQGLQFDVHV LQQ RQO\WKH13LQFUHDVHGLQQ RQO\F7LQFUHDVHG DQGLQQ 13DQG*6LQFUHDVHG ,QWKHUHPDLQLQJFDVHVQRGLᚎHUHQFHVZHUHIRXQG Q RUPRUHIDYRXUDEOHIHDWXUHV were found (in n=2 only NP decreased and in n=1 cT decreased). Conclusions: Primarily, it should be noted that the false-negative rate of 9.9% found in this study is not indicative for the general population, but an over-estimation. All men were diagnosed with PC four years later and were therefore at increased risk of a prior missed lesion. Secondly, the review performed in this study was biased by the knowledge that every man was diagnosed with PC 4 years later. Although general features become less favourable in most men with a prior missed lesion of PC, the majority still seems to be in a curable stage. An explanation for this could be the preclinical phase in which the screen-detected PC is found, with a mean lead time estimated to be around 10 years in RXUSRSXODWLRQ7KLVPD\LPSO\WKDWWKHHᚎHFWVRIPLVVLQJD3&OHVLRQ\HDUVHDUOLHUDUHQRWQHFHVVDULO\QHJDWLYHIRU patient outcome in this screened cohort. However, as follow-up is not long enough to establish whether the PC detected DIWHUPLVVLQJDOHVLRQZDVFOLQLFDOO\VLJQLᚏFDQWFXUDEOHLQFXUDEOHRUHYHQIDWDOWKHWUXHLPSOLFDWLRQVRIPLVVLQJD3& lesion on biopsy specimens remain unclear.
Introduction & Objectives: 5HFHQWO\ ZH GHYHORSHG D PXOWLVWHS ULVN FDOFXODWRU >@ 7KH ᚏUVW VWHSV (based on data of 6,288 men screened at the 1st screening round of the Dutch part of the European Randomised study of Screening for prostate cancer (ERSPC)are meant for lay men and can be used to estimate the risk of having a biopsy detectable PC ((P)posb) using basal information such as age DQGIDPLO\KLVWRU\6WHSHQDEOHVXURORJLVWVWRHVWLPDWHDPDQಬVFXUUHQW 3 SRVEDQGLVEDVHGRQWKH screening results (serum PSA level, result of DRE and TRUS, prostate volume and biopsy outcome) of PHQ+HUHZHUHODWHWKLVFXUUHQWULVNWRVFUHHQLQJUHVXOWV\UVODWHU Material & Methods: :LWKWKHULVNFDOFXODWRUZHFDOFXODWHGWKH3 SRVE RIPHQZLWKDQLQLWLDO36$ OHYHORI QJPO7KHVHPHQZHUHQRWELRSVLHGEXWUHLQYLWHGIRUDQGVFUHHQLQJYLVLW\UVODWHU 6WUDWLᚏHG3 SRVE ZHUHUHODWHGWRQXPEHURIPHQZLWK36$! QJPODQG3&GHWHFWLRQ\UVODWHU and the predictive value of the calculated P(posb) on PC detection 4 yrs later was assessed by logistic regression analysis. Results: $WQGVFUHHQLQJPHQ RI KDGD36$! QJPO PHQELRSVLHG DQG 3&ZHUHGHWHFWHG 339 &'5 7KHᚏJXUHVKRZVWKHSRVLWLYHFRUUHODWLRQRI3 SRVE with an elevated PSA level and PC detection 4 yrs later. Men with a baseline P(posb) < 5% ( 72% of WRWDOFRKRUW KDYHDFKDQFHRIKDYLQJD36$! QJPO DQGDFKDQFH of a biopsy detectable PC 4 yrs later (26/26+2285). The odds ratio of P(posb) was 1.2 (univariate, p < 0.001). Correcting for PSA,DRE,TRUS and prostate volume at 2nd screening the P(posb) remained a VLJQSUHGLFWRU RGGVUDWLRS Conclusions: The risk calculator® (http://www.uroweb.org/) is capable of independently predicting PC risk at least 4 yrs before diagnosis. Data show that the majority of asymptomatic men in the age range ZLWKD36$ QJPOKDYHDYHU\ORZ3 SRVE ZKLFKUHPDLQVFRQVWDQWGXULQJWKHDWOHDVW IROORZLQJ \UV 7KLV LV FRQVLVWHQW ZLWK GDWD RI &RQQROO\ HW DO>@ WKDW VKRZ WKDW 3& DQG GHDWK IURP 3& is rare in men with low PSA levels. The risk calculator® can be of help in the awareness of the likelihood of having a diagnosis of PC and in determining an individualized screening interval with the goal to reduce PSA testing and prostate biopsies that lead to unnecessary anxiety and costs. 1. Kranse et al. submitted 2. Conolly et al. AUA 2007,#1890
Eur Urol Suppl 2008;7(3):273