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DISTRIBUTION OF HIGH CHROMOGRANIN A (CGA) SERUM LEVELS IN PATIENTS WITH NON-METASTATIC AND METASTATIC PROSTATE ADENOCARCINOMA
621
622
ANALYSIS OF THE EPSTEIN CRITERIA FOR INSIGNIFICANT PROSTATE CANCER IN AUSTRALIA
CHRONIC INFLAMMATION OF THE PROSTATE AS A RISK FACTOR FOR PROSTATE CANCER: A 4 YEAR FOLLOW UP STUDY
Thanigasalam R.1, Stricker D.2, Sutherland S.1, Sutherland L.1, Haynes M.1, Henshall M.1, Rasiah K.1
Reissigl A.1, Wiunig Ch.1, Neyer M.1, Grunser H.1, Remzi M.2, Pointner J.1
1
Garvan Institute of Medical Research, Dept. of Prostate Cancer Research, Sydney, Australia, 2St. Vincent’s Clinic, Dept. of Urology, Sydney, Australia Introduction & Objectives: The 1994 Epstein criteria remain widely used by clinicians WRDVVHVVIRUFOLQLFDOO\ಯLQVLJQLᚏFDQWರSURVWDWHFDQFHU ,3&D (SVWHLQಬVRULJLQDO VWXG\ DFFXUDWHO\SUHGLFWHGRISDWLHQWVZLWK,3&DDQGKDGDSRVLWLYHSUHGLFWLYHYDOXHRI Studies in Europe and North America have tested the validity of the Epstein criteria, however these criteria have not been validated in a large cohort of Australasian patients. We tested the clinico-pathological validity of the criteria using prospectively collected data from a large prostate cancer database of Australian men who have undergone radical prostatectomy as a monotherapy for localised prostate cancer. Material & Methods: Between June 1st 1997 and July 1st 2007, 2248 radical prostatectomies for clinically localised prostate cancer were performed at a single Sydney hospital (SVH), of WKHVH ZHUHIRUFOLQLFDOVWDJH7FWXPRXUVDQG RIWKHVHPHWWKH (SVWHLQ FULWHULD IRU ,3&D SURVWDWHVSHFLᚏF DQWLJHQ GHQVLW\ QJP/ ELRSV\ *OHDVRQ VXPIHZHUWKDQFRUHVFRQWDLQLQJSURVWDWHFDUFLQRPDDQGQRPRUHWKDQWXPRXU LQYROYHPHQWRIDQ\FRUHZLWKSURVWDWHFDUFLQRPD7KHSRVWVXUJLFDOSDWKRORJLFDOᚏQGLQJVRI extra-capsular extension (ECE), seminal vesicle involvement (SVI), lymph node invasion (LNI) and rate of a higher grade prostate cancer (Gleason 7-10) at radical prostatectomy were used as separate end points. Absence of these features of more aggressive disease progression, were examined for potential correlation with IPCa. Results: 2IWKHSDWLHQWVWKDWPHWWKH(SVWHLQFULWHULD(&(ZDVSUHVHQWLQ SVI in 4 (2.0%), LNI in 0 (0%) and a higher grade PCa (Gleason 7-10) in 86 (42%). Combined DEVHQFH RI (&( 69, /1, DQG KLJKHU JUDGH 3& ZDV QRWHG LQ SDWLHQWV 7KH presence of any adverse characteristics (ECE, SVI, LNI and higher grade PCa) was noted in SDWLHQWV7KHVHQVLWLYLW\RIWKH(SVWHLQFULWHULDLQGHWHFWLQJFOLQLFDOO\LQVLJQLᚏFDQW SURVWDWHFDQFHULQDQ$XVWUDOLDQSRSXODWLRQZDV &, 7KHFRQᚏGHQFH Interval was based on a binomial exact distribution. Conclusions: The Epstein criteria have a relatively high error rate when validated in an $XVWUDOLDQSRSXODWLRQIRULQVLJQLᚏFDQWSURVWDWHFDQFHUZLWK RISDWLHQWVKDYLQJFOLQLFDOO\ VLJQLᚏFDQWGLVHDVHDQGEHLQJXSVWDJHGWRDKLJKHUJUDGH3&D *OHDVRQ :LWK the predictive accuracy of the criteria being 55%, our study provides a stark demonstration WKDWWKHYDOLGLW\RIWKH(SVWHLQFULWHULDLQSUHGLFWLQJFOLQLFDOO\LQVLJQLᚏFDQWSURVWDWHFDQFHULQ an Australian population needs to be re-assessed.
1
Landeskrankenhaus Bregenz, Dept. of Urology, Bregenz, Austria, Allgemeines Krankenhaus- Universitätskliniken Wien, Dept. of Urology, Vienna, Austria
2
Introduction & Objectives: &KURQLF LQᚐDPPDWLRQ RI WKH SURVWDWH KDV IUHTXHQWO\ EHHQ LGHQWLᚏHG LQ ELRSVLHV EDVHG RQ SURVWDWH VSHFLᚏF DQWLJHQ (PSA) elevation. In recent studies has been suggested that prostate HSLWKHOLXPH[SRVHGWRFKURQLFHᚎHFWVRILQᚐDPPDWLRQPD\OHDGWRPDOLJQDQW alterations based on genetic changes. We studied the correlation of biopsy SURYHQFKURQLFSURVWDWLWLVZLWKᚏQGLQJVLQVXEVHTXHQWELRSVLHVLQWKHVDPH patients. Material & Methods: Overall 205 consecutive men were included, 105 men who initially were diagnosed with chronic prostatitis and 100 men ZLWKRXWLQᚐDPPDWLRQZHUHIXUWKHULQYHVWLJDWHGDQGIROORZXSELRSVLHVZHUH correlated with the initial results. Results: ,QUHSHDWELRSVLHVSHUIRUPHGZLWKLQ\HDUV SURVWDWHFDQFHUV ZHUHGLDJQRVHG LQWKHFKURQLFLQᚐDPPDWLRQJURXS2IWKHVHFDQFHUV GHWHFWHG ZHUH IRXQG LQ SDWLHQWV ZLWK H[FOXVLYHO\ FKURQLF LQᚐDPPDWLRQ results, 10 occurred in patients with post atrophic hyperplasia and chronic prostatitis and 1 was found in a patient with initially detected high grade SURVWDWLF LQWUDHSLWKHOLDO QHRSODVLD +*3,1 DQG FKURQLF LQᚐDPPDWLRQ Further more, isolated HG-PIN was newly diagnosed in 10 patients. In the VHFRQG VWXG\ JURXS ZLWKRXW FKURQLF LQᚐDPPDWLRQ SURVWDWH FDQFHU ZDV IRXQGLQSDWLHQWV 7KHUHZHUHRQO\VOLJKWGLᚎHUHQFHVLQPHDQ36$ values and mean PSA velocity between both groups (p-value 0.07, 0.08). Conclusions: 7KHVHᚏQGLQJVVXJJHVWWKDWFKURQLFLQᚐDPPDWLRQPD\EHD risk factor for prostate cancer development.
623
1016
DISTRIBUTION OF HIGH CHROMOGRANIN A (CGA) SERUM LEVELS IN PATIENTS WITH NON-METASTATIC AND METASTATIC PROSTATE ADENOCARCINOMA
THE ABILITY OF PROSTATE HISTOSCANNING[TM] TO IDENTIFY LOW VOLUME PROSTATE CANCER TUMOUR FOCI
Sciarra A., Gentile V., Salciccia S., Autran Gomez A., Alfarone A., Iannotta L., Di Silverio F. University Sapienza, Dept. of Urology, Rome, Italy Introduction & Objectives: we analyzed the incidence of elevated serum levels of CgA ( as marker of neuroendocrine activity ) in non metastatic and metastatic prostate cancer populations. Material & Methods: 264 consecutive men with non metastatic prostate adenocarcinoma considered for radical prostatectomy (Group 1) and 89 consecutive men with metastatic prostate adenocarcinoma (Group UHSUHVHQWHG RXU SRSXODWLRQ ,Q DOO FDVHV D EORRG VDPSOH IRU WKH determination of serum total PSA and CgA levels was obtained (RIA). Two GLᚎHUHQWFXWRᚎIRUHOHYDWHGVHUXP&J$OHYHOVZHUHXVHG !QJPODQG > 90 ng/ml. Results: ,Q *URXS RI FDVHV SUHVHQWHG &J$ OHYHOV ! QJPO and 6.4 % > 90 ng/ml. In Group 2, 100 % cases presented a CgA levels > 60 ng/ml and 69.7% > 90 ng/ml. The OR for CgA level > 60 ng/ml and > QJPOVLJQLᚏFDQWO\LQFUHDVHGIURPQRQPHWDVWDWLFWRPHWDVWDWLFFDVHV p= 0.0001). In Group 1 the percentage of cases with CgA > 60 ng/ml was LQ*OHDVRQVFRUHื DQGLQ*OHDVRQVFRUHุ (p= 0.0001). In Group 2, the percentage of cases with CgA > 90 ng/ml was LQ*OHDVRQVFRUHื DQGLQ*OHDVRQVFRUHุ (p= 0.0028). Conclusions: ZH GHVFULEHG D VLJQLᚏFDQW LQFLGHQFH RI HOHYDWHG VHUXP OHYHOV RI &J$ HLWKHU LQ QRQ PHWDVWDWLF XVLQJ QJPO DV FXW Rᚎ RU LQ PHWDVWDWLF XVLQJ QJPODVFXWRᚎ SURVWDWHDGHQRFDUFLQRPDFDVHV
Eur Urol Suppl 2008;7(3):226
Braeckmann J.1, Marichal M.2, Michielson D.1, Garbar C.2, Soviany C., Nir R., Nir D., Bleiberg H.4, Autier P.5, Egevard L.6, Emberton M.7 1 UZ Brussel,Vrije Universiteit, Dept. of Urology, Brussels, Belgium, 2UZ Brussel,Vrije Universiteit, Dept. of Pathology, Brussels, Belgium, Advanced Medical Diagnostics, Dept. of R&D, Waterloo, Belgium, 4Advanced Medical Diagnostics, 'HSWRI0HGLFDO$ᚎDLUV:DWHUORR%HOJLXP 5International Agency for Research on Cancer, Dept. of Biostatistics and Epidemiology, Lyon, France, 6International Agency for Research on Cancer, Dept. of Cancer Research, Lyons, France, 7 University College London, Division of Surgery and Interventional Science, London, United Kingdom
Introduction & Objectives: To date, imaging has not been particularly helpful in characterizing prostate cancer tumour foci, particularly if the foci in question are those less than 0.5cc in volume. At present the best method available to us LV D PXOWLVHTXHQFH 05, VFDQ WKDW LQFRUSRUDWHV 7 DQG 7 '\QDPLF SKDVHV LQ FRQMXQFWLRQ ZLWK GLᚎXVLRQ PDSV DQG spectroscopy. The best results in the literature show PPVs of 86% and 77% for lesions measuring 0.2 and 0.5cc, respectively. We report an analysis of data derived from a Phase 1 diagnostic study in order to establish the extent to which Prostate HistoScanningTM (PHS) can reach equivalence or superiority to these levels of diagnostic accuracy. Material & Methods: SDWLHQWV XQGHUZHQW 3+6 HYDOXDWLRQ SULRU WR D VFKHGXOHG UDGLFDO SURVWDWHFWRP\ 7KH 3+6 evaluation involves an analysis of the backscattered raw signal generated by transrectal ultrasound of the prostate. This backscatter is subjected to tissue characterization algorithms that determine the presence or absence of prostate cancer lesions. The PHS volume detection threshold was set at 0.2cc and 0.5cc, chosen in line with published data UHODWHGWRRWKHUPRGDOLWLHV7KHYHULᚏFDWLRQRIWKHGHWHFWHGYROXPHVZDVDFKLHYHGE\KLVWRORJLFDOUHYLHZRIPPVWHS sectioned whole prostates. Results: ,QWRWDOFDQFHUOHVLRQVZHUHLGHQWLᚏHGLQSDWKRORJ\7KHPDMRULW\ RIWKHVHOHVLRQVZHUH FFDQG PD\EHFRQVLGHUHGFOLQLFDOO\LQGROHQW3+6LGHQWLᚏHGDOOOHVLRQVH[FHSWIRUZKLFKKDGDYROXPHRIFF:KHQWKH volume detection threshold was set at 0.2cc both the sensitivity and the PPV were 95% for cancer lesions >0.2cc. When set at 0.5cc both the sensitivity and the PPV were 100% for cancer lesions >0.5cc. The results are summarised below. Summary of results with PHS volume detection thresholds set at 0.2cc and 0.5cc: Volume of cancer lesions as measured at histology 0.2-0.49 1* 4 8
>0.5 0 0 12 12
Total 162 4 15 181
Volume of cancer lesions as measured by PHS (cc) Below PHS 0.2 threshold 0.2-0.49 >0.5 Total
<0.01
0.01-0.049
0.05-0.09
0.1-0.19
67 0 0 67
72 0 0 72
14 0 0 14
8 0 0 8
* False negative: Volume of 0.20 at histology Sensitivity 3&DุFF 95% 75%
PPV 3&DุFF 100% 100%
3&DุFF 95% 100%
3&DุFF 60% 100%
PHS volume detection threshold 0.2cc 0.5cc
Conclusions: PHS, when set to detect lesions greater than or equal to 0.2cc or 0.5cc, showed a high sensitivity in both detection and volume estimation of small cancerous lesions within the prostrate when compared with histological examination of the whole gland. The sensitivity and PPVs attained in this phase 1 diagnostic study demonstrate at least equivalent and possibly superior results compared to those published to date using other imaging modalities. These early results show that HistoScanning is a promising method of characterizing prostate cancer lesions of various volumes. Further studies are required both in this setting and in areas of screening, staging, therapy triaging and surveillance.
622
ANALYSIS OF THE EPSTEIN CRITERIA FOR INSIGNIFICANT PROSTATE CANCER IN AUSTRALIA
CHRONIC INFLAMMATION OF THE PROSTATE AS A RISK FACTOR FOR PROSTATE CANCER: A 4 YEAR FOLLOW UP STUDY
Thanigasalam R.1, Stricker D.2, Sutherland S.1, Sutherland L.1, Haynes M.1, Henshall M.1, Rasiah K.1
Reissigl A.1, Wiunig Ch.1, Neyer M.1, Grunser H.1, Remzi M.2, Pointner J.1
1
Garvan Institute of Medical Research, Dept. of Prostate Cancer Research, Sydney, Australia, 2St. Vincent’s Clinic, Dept. of Urology, Sydney, Australia Introduction & Objectives: The 1994 Epstein criteria remain widely used by clinicians WRDVVHVVIRUFOLQLFDOO\ಯLQVLJQLᚏFDQWರSURVWDWHFDQFHU ,3&D (SVWHLQಬVRULJLQDO VWXG\ DFFXUDWHO\SUHGLFWHGRISDWLHQWVZLWK,3&DDQGKDGDSRVLWLYHSUHGLFWLYHYDOXHRI Studies in Europe and North America have tested the validity of the Epstein criteria, however these criteria have not been validated in a large cohort of Australasian patients. We tested the clinico-pathological validity of the criteria using prospectively collected data from a large prostate cancer database of Australian men who have undergone radical prostatectomy as a monotherapy for localised prostate cancer. Material & Methods: Between June 1st 1997 and July 1st 2007, 2248 radical prostatectomies for clinically localised prostate cancer were performed at a single Sydney hospital (SVH), of WKHVH ZHUHIRUFOLQLFDOVWDJH7FWXPRXUVDQG RIWKHVHPHWWKH (SVWHLQ FULWHULD IRU ,3&D SURVWDWHVSHFLᚏF DQWLJHQ GHQVLW\ QJP/ ELRSV\ *OHDVRQ VXPIHZHUWKDQFRUHVFRQWDLQLQJSURVWDWHFDUFLQRPDDQGQRPRUHWKDQWXPRXU LQYROYHPHQWRIDQ\FRUHZLWKSURVWDWHFDUFLQRPD7KHSRVWVXUJLFDOSDWKRORJLFDOᚏQGLQJVRI extra-capsular extension (ECE), seminal vesicle involvement (SVI), lymph node invasion (LNI) and rate of a higher grade prostate cancer (Gleason 7-10) at radical prostatectomy were used as separate end points. Absence of these features of more aggressive disease progression, were examined for potential correlation with IPCa. Results: 2IWKHSDWLHQWVWKDWPHWWKH(SVWHLQFULWHULD(&(ZDVSUHVHQWLQ SVI in 4 (2.0%), LNI in 0 (0%) and a higher grade PCa (Gleason 7-10) in 86 (42%). Combined DEVHQFH RI (&( 69, /1, DQG KLJKHU JUDGH 3& ZDV QRWHG LQ SDWLHQWV 7KH presence of any adverse characteristics (ECE, SVI, LNI and higher grade PCa) was noted in SDWLHQWV7KHVHQVLWLYLW\RIWKH(SVWHLQFULWHULDLQGHWHFWLQJFOLQLFDOO\LQVLJQLᚏFDQW SURVWDWHFDQFHULQDQ$XVWUDOLDQSRSXODWLRQZDV &, 7KHFRQᚏGHQFH Interval was based on a binomial exact distribution. Conclusions: The Epstein criteria have a relatively high error rate when validated in an $XVWUDOLDQSRSXODWLRQIRULQVLJQLᚏFDQWSURVWDWHFDQFHUZLWK RISDWLHQWVKDYLQJFOLQLFDOO\ VLJQLᚏFDQWGLVHDVHDQGEHLQJXSVWDJHGWRDKLJKHUJUDGH3&D *OHDVRQ :LWK the predictive accuracy of the criteria being 55%, our study provides a stark demonstration WKDWWKHYDOLGLW\RIWKH(SVWHLQFULWHULDLQSUHGLFWLQJFOLQLFDOO\LQVLJQLᚏFDQWSURVWDWHFDQFHULQ an Australian population needs to be re-assessed.
1
Landeskrankenhaus Bregenz, Dept. of Urology, Bregenz, Austria, Allgemeines Krankenhaus- Universitätskliniken Wien, Dept. of Urology, Vienna, Austria
2
Introduction & Objectives: &KURQLF LQᚐDPPDWLRQ RI WKH SURVWDWH KDV IUHTXHQWO\ EHHQ LGHQWLᚏHG LQ ELRSVLHV EDVHG RQ SURVWDWH VSHFLᚏF DQWLJHQ (PSA) elevation. In recent studies has been suggested that prostate HSLWKHOLXPH[SRVHGWRFKURQLFHᚎHFWVRILQᚐDPPDWLRQPD\OHDGWRPDOLJQDQW alterations based on genetic changes. We studied the correlation of biopsy SURYHQFKURQLFSURVWDWLWLVZLWKᚏQGLQJVLQVXEVHTXHQWELRSVLHVLQWKHVDPH patients. Material & Methods: Overall 205 consecutive men were included, 105 men who initially were diagnosed with chronic prostatitis and 100 men ZLWKRXWLQᚐDPPDWLRQZHUHIXUWKHULQYHVWLJDWHGDQGIROORZXSELRSVLHVZHUH correlated with the initial results. Results: ,QUHSHDWELRSVLHVSHUIRUPHGZLWKLQ\HDUV SURVWDWHFDQFHUV ZHUHGLDJQRVHG LQWKHFKURQLFLQᚐDPPDWLRQJURXS2IWKHVHFDQFHUV GHWHFWHG ZHUH IRXQG LQ SDWLHQWV ZLWK H[FOXVLYHO\ FKURQLF LQᚐDPPDWLRQ results, 10 occurred in patients with post atrophic hyperplasia and chronic prostatitis and 1 was found in a patient with initially detected high grade SURVWDWLF LQWUDHSLWKHOLDO QHRSODVLD +*3,1 DQG FKURQLF LQᚐDPPDWLRQ Further more, isolated HG-PIN was newly diagnosed in 10 patients. In the VHFRQG VWXG\ JURXS ZLWKRXW FKURQLF LQᚐDPPDWLRQ SURVWDWH FDQFHU ZDV IRXQGLQSDWLHQWV 7KHUHZHUHRQO\VOLJKWGLᚎHUHQFHVLQPHDQ36$ values and mean PSA velocity between both groups (p-value 0.07, 0.08). Conclusions: 7KHVHᚏQGLQJVVXJJHVWWKDWFKURQLFLQᚐDPPDWLRQPD\EHD risk factor for prostate cancer development.
623
1016
DISTRIBUTION OF HIGH CHROMOGRANIN A (CGA) SERUM LEVELS IN PATIENTS WITH NON-METASTATIC AND METASTATIC PROSTATE ADENOCARCINOMA
THE ABILITY OF PROSTATE HISTOSCANNING[TM] TO IDENTIFY LOW VOLUME PROSTATE CANCER TUMOUR FOCI
Sciarra A., Gentile V., Salciccia S., Autran Gomez A., Alfarone A., Iannotta L., Di Silverio F. University Sapienza, Dept. of Urology, Rome, Italy Introduction & Objectives: we analyzed the incidence of elevated serum levels of CgA ( as marker of neuroendocrine activity ) in non metastatic and metastatic prostate cancer populations. Material & Methods: 264 consecutive men with non metastatic prostate adenocarcinoma considered for radical prostatectomy (Group 1) and 89 consecutive men with metastatic prostate adenocarcinoma (Group UHSUHVHQWHG RXU SRSXODWLRQ ,Q DOO FDVHV D EORRG VDPSOH IRU WKH determination of serum total PSA and CgA levels was obtained (RIA). Two GLᚎHUHQWFXWRᚎIRUHOHYDWHGVHUXP&J$OHYHOVZHUHXVHG !QJPODQG > 90 ng/ml. Results: ,Q *URXS RI FDVHV SUHVHQWHG &J$ OHYHOV ! QJPO and 6.4 % > 90 ng/ml. In Group 2, 100 % cases presented a CgA levels > 60 ng/ml and 69.7% > 90 ng/ml. The OR for CgA level > 60 ng/ml and > QJPOVLJQLᚏFDQWO\LQFUHDVHGIURPQRQPHWDVWDWLFWRPHWDVWDWLFFDVHV p= 0.0001). In Group 1 the percentage of cases with CgA > 60 ng/ml was LQ*OHDVRQVFRUHื DQGLQ*OHDVRQVFRUHุ (p= 0.0001). In Group 2, the percentage of cases with CgA > 90 ng/ml was LQ*OHDVRQVFRUHื DQGLQ*OHDVRQVFRUHุ (p= 0.0028). Conclusions: ZH GHVFULEHG D VLJQLᚏFDQW LQFLGHQFH RI HOHYDWHG VHUXP OHYHOV RI &J$ HLWKHU LQ QRQ PHWDVWDWLF XVLQJ QJPO DV FXW Rᚎ RU LQ PHWDVWDWLF XVLQJ QJPODVFXWRᚎ SURVWDWHDGHQRFDUFLQRPDFDVHV
Eur Urol Suppl 2008;7(3):226
Braeckmann J.1, Marichal M.2, Michielson D.1, Garbar C.2, Soviany C., Nir R., Nir D., Bleiberg H.4, Autier P.5, Egevard L.6, Emberton M.7 1 UZ Brussel,Vrije Universiteit, Dept. of Urology, Brussels, Belgium, 2UZ Brussel,Vrije Universiteit, Dept. of Pathology, Brussels, Belgium, Advanced Medical Diagnostics, Dept. of R&D, Waterloo, Belgium, 4Advanced Medical Diagnostics, 'HSWRI0HGLFDO$ᚎDLUV:DWHUORR%HOJLXP 5International Agency for Research on Cancer, Dept. of Biostatistics and Epidemiology, Lyon, France, 6International Agency for Research on Cancer, Dept. of Cancer Research, Lyons, France, 7 University College London, Division of Surgery and Interventional Science, London, United Kingdom
Introduction & Objectives: To date, imaging has not been particularly helpful in characterizing prostate cancer tumour foci, particularly if the foci in question are those less than 0.5cc in volume. At present the best method available to us LV D PXOWLVHTXHQFH 05, VFDQ WKDW LQFRUSRUDWHV 7 DQG 7 '\QDPLF SKDVHV LQ FRQMXQFWLRQ ZLWK GLᚎXVLRQ PDSV DQG spectroscopy. The best results in the literature show PPVs of 86% and 77% for lesions measuring 0.2 and 0.5cc, respectively. We report an analysis of data derived from a Phase 1 diagnostic study in order to establish the extent to which Prostate HistoScanningTM (PHS) can reach equivalence or superiority to these levels of diagnostic accuracy. Material & Methods: SDWLHQWV XQGHUZHQW 3+6 HYDOXDWLRQ SULRU WR D VFKHGXOHG UDGLFDO SURVWDWHFWRP\ 7KH 3+6 evaluation involves an analysis of the backscattered raw signal generated by transrectal ultrasound of the prostate. This backscatter is subjected to tissue characterization algorithms that determine the presence or absence of prostate cancer lesions. The PHS volume detection threshold was set at 0.2cc and 0.5cc, chosen in line with published data UHODWHGWRRWKHUPRGDOLWLHV7KHYHULᚏFDWLRQRIWKHGHWHFWHGYROXPHVZDVDFKLHYHGE\KLVWRORJLFDOUHYLHZRIPPVWHS sectioned whole prostates. Results: ,QWRWDOFDQFHUOHVLRQVZHUHLGHQWLᚏHGLQSDWKRORJ\7KHPDMRULW\ RIWKHVHOHVLRQVZHUH FFDQG PD\EHFRQVLGHUHGFOLQLFDOO\LQGROHQW3+6LGHQWLᚏHGDOOOHVLRQVH[FHSWIRUZKLFKKDGDYROXPHRIFF:KHQWKH volume detection threshold was set at 0.2cc both the sensitivity and the PPV were 95% for cancer lesions >0.2cc. When set at 0.5cc both the sensitivity and the PPV were 100% for cancer lesions >0.5cc. The results are summarised below. Summary of results with PHS volume detection thresholds set at 0.2cc and 0.5cc: Volume of cancer lesions as measured at histology 0.2-0.49 1* 4 8
>0.5 0 0 12 12
Total 162 4 15 181
Volume of cancer lesions as measured by PHS (cc) Below PHS 0.2 threshold 0.2-0.49 >0.5 Total
<0.01
0.01-0.049
0.05-0.09
0.1-0.19
67 0 0 67
72 0 0 72
14 0 0 14
8 0 0 8
* False negative: Volume of 0.20 at histology Sensitivity 3&DุFF 95% 75%
PPV 3&DุFF 100% 100%
3&DุFF 95% 100%
3&DุFF 60% 100%
PHS volume detection threshold 0.2cc 0.5cc
Conclusions: PHS, when set to detect lesions greater than or equal to 0.2cc or 0.5cc, showed a high sensitivity in both detection and volume estimation of small cancerous lesions within the prostrate when compared with histological examination of the whole gland. The sensitivity and PPVs attained in this phase 1 diagnostic study demonstrate at least equivalent and possibly superior results compared to those published to date using other imaging modalities. These early results show that HistoScanning is a promising method of characterizing prostate cancer lesions of various volumes. Further studies are required both in this setting and in areas of screening, staging, therapy triaging and surveillance.