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    B2012 12794-01%202012%20 eau%20exhibit%20-%20eau%20poster%20abstract%20guide%20r2-jsb[1] B2012 12794-01%202012%20 eau%20exhibit%20-%20eau%20poster%20abstract%20guide%20r2-jsb[1] Presentation Transcript

    • ProstateHealthIndex.org Your path to improved PCa guidance starts with a click. EAU Guide to the Scientific Abstracts Regarding the Prostate Health Index (phi)*ProstateHealthIndex.org is dedicated to give you the resources toanswer the questions you have regarding improving prostate cancer Poster Sessionsdetection with the Prostate Health Index test. Presented at the 27th Annual EAU CongressWith just a click you can find: Paris, France • Information on phi and how it can help your patients • Latest clinical evidence • Online presentations from experts • Directory of authorized phi laboratoriesTools for you and your patients: • Online prostate and phi information for patients • Free educational brochures for your office • Free listings in the phi Physician Network* *Available for phi Network approved physicians and laboratories. Contact your Beckman Coulter representative for details. Exclusive content for 2012 EAU attendeesVisit ProstateHealthIndex.org/EAU2012 • Download the EAU Guide to phi Scientific Poster Presentations to share with your colleagues • Connect with the phi specialists from Beckman Coulter • Contribute your opinions about the Prostate Health Index Stay Connected With your web-enabled camera phone scan the QR Code with a QR Code reader application. Get the latest information at www.ProstateHealthIndex.org Space for FSC Logo Beckman Coulter, the stylized logo, Access and UniCel are registered trademarks of Beckman Coulter, Inc., and are registered in the USPTO. Printed with soy ink For Beckman Coulter’s worldwide office locations and phone numbers, please visit “Contact Us” at www.beckmancoulter.com B2012-12794-01-DG-XX © 2012 Beckman Coulter, Inc. PRINTED IN U.S.A. BR-16561A *Not available in the U.S.
    • Poster Presentation Schedule and Abstract Index Saturday, 25 February, 16:00 – 17:30; Location: Level 2 – Room 251 2 Poster Session 22: Prostate Biopsies 2 Level 4 Level 4 Level 3 Level 2 (259) Serum isoform [-2]proPSA (p2PSA) and its derivates, %p2PSA and phi Level 1 Level 0 (Prostate Health Index), are more accurate than the reference standard test -1 -2 Level -1 (PSA) in men scheduled for repeat biopsy Saturday, 25 February, 16:00 - 17:30; Location: Level 2 - Room 251 3 Poster Session 22: Prostate Biopsies 2 (260) The cost-effectiveness of prostate cancer detection using Beckman Room 251 Room 252 Coulter Prostate Health Index Saturday, 25 February, 16:00 – 17:30; Location: Level 2 – Room 252 A/B Level 2 4 Poster Session 23: Chronic Pelvic Pain Syndrome eURO (278) Correlation of chronic histologic prostatic inflammation (CHPI) in biopsy Auditorium specimens with serum isoform [-2]proPSA (p2PSA), %p2PSA and phi (ProstateFirst Aid Health Index) in men undergoing prostate biopsy for suspected PCaRooms 212 -213 Hall Pas sy Monday, 27 February, 12:15 – 13:45; Location: Level 2 – Room 252 A/B Exhibition 5 Poster Session 76: Prostate Cancer: Biomarkers (909) Clinical cut-offs of isoform [-2]proPSA (p2PSA) derivatives, namely %p2PSA and phi (Prostate Health Index) for guiding biopsy decision in Caucasian population Hall Ternes Monday, 27 February, 12:15 – 13:45; Location: Level 2 – Room 252 A/B Level 1 Hall Neuilly 6 Poster Session 76: Prostate Cancer: Biomarkers (910) Isoform [-2]proPSA (p2PSA) and its derivates, %p2PSA and phi values eURO differ between BPH, ASAP, HG-PIN and PCa in a set of contemporary men Auditorium undergoing prostate biopsy Beckman Coulter Hall Passy Booth No. 1PO6 Hall Paris Monday, 27 February, 12:15 – 13:45; Location: Level 2 – Room 252 A/B 7 Poster Session 76: Prostate Cancer: Biomarkers Exhibition (912) Comparison of phi (Prostate Health Index) and PCA3 assay in the prediction of prostate biopsy (PBx) outcome in patients who have undergone initial and repeated prostatic biopsies 1
    • Abstract 259; Saturday, 25 February 2012 Abstract 260; Saturday, 25 February 2012 Serum isoform [-2]proPSA (p2PSA) and its derivates, %p2PSA and phi (Prostate Health Index), are more The cost-effectiveness of prostate cancer detection accurate than the reference standard test (PSA) in men using Beckman Coulter Prostate Health Index scheduled for repeat biopsy AUTHORS: Lazzeri M1, Lughezzani G1, Larcher A1, Gadda G1, Scattoni V1, Sangalli M1, Nava L2, Bini V3, AUTHORS: Heijnsdijk EAM1, Huang JT2, Denham D2, de Koning HJ1 Maga T1, Bellinzoni P1, Cestari A1, Rigatti P1, Guazzoni G1 CENTERS: 1 Erasmus MC, Department of Public Health, Rotterdam, Netherlands 2 Beckman Coulter, Inc., Brea, California, United States CENTER: 1 University Vita-Salute, Department of Urology, Milan, Italy 2 Fondazione “Opera S. Camillo”, Department of Urology, Milan, Italy 3 University of Perugia, Department of Internal Medicine, Perugia, Italy Introduction & Objectives: Introduction & Objectives: This study tests the hypothesis that [-2]proPSA (p2PSA) and its derivates, namely %p2PSA and phi Clinical trial results suggested that PSA screening may reduce prostate cancer mortality in the EU healthcare (Prostate Health Index), are more accurate than reference standard tests (tPSA, fPSA and %fPSA) in setting. However, the specificity of the PSA of the PSA test for prostate cancer is low, leading to many detecting PCa in men scheduled for repeat biopsy. negative prostate biopsies. The Beckman Coulter Prostate Health Index (phi) demonstrates improved specificity compared to PSA alone, therefore, may reduce negative biopsies. In the present study, the cost- Material & Methods: effectiveness of phi testing is compared with PSA screening. This study was an observational prospective evaluation of a cohort of men with one or two previous negative prostate biopsies, with persistent suspicion of PCa (suspected DRE, elevated tPSA and or Material & Methods: low %fPSA) who were scheduled for repeat biopsy. Men receiving medical therapy known to affect Based on the results of the European Randomized Study of Screening for Prostate Cancer, the ERSPC trial, serum PSA (dutasteride and finasteride), suffering from prostatitis and having had invasive treatment a micro-simulation model was used to evaluate the effects of PSA screening and phi testing for a European for benign prostatic hyperplasia (BPH), such as TURP or HoLEP, were excluded. Serum p2PSA, and it population. The model simulates individual life histories from birth to death, while taking into account that derivates, namely %p2PSA {([-2]proPSA/10)/fPSA)} and Beckman Coulter phi (Prostate Health Index) some individuals will develop prostate cancer, clinically or preclinically. When screening tests are applied to {[[-2]proPSA/fPSA] x squart PSA} were considered the index tests and compared with the reference a person in a preclinical disease state, they may result in cancer detection and alteration of the life history standard tests (tPSA, fPSA and %fPSA). All the patients underwent ambulatory repeated TRUS-guided of this individual. Utility values were obtained from literature. We predicted the numbers of prostate cancers, prostate biopsies (18-22 cores). The primary outcome was to evaluate the accuracy of p2PSA and its negative biopsies, deaths, quality-adjusted life-years (QALYs) gained and the cost-effectiveness of using derivates in detecting PCa. PSA (cut-off ≥3 ng/ml) and phi (cut-off ≥25) testing methods to recommend prostate biopsies. In the phi testing situation, phi was added to the model for men with a PSA between 3 and 10 ng/ml. The model Results: assumed screening of men from age 50 to 75 years old every four years. From June 2010 and June 2011, 222 men underwent repeated biopsy at our single high-volume centre. PCa cancer was found in 71/222 (31.9%) subjects. p2PSA, %p2PSA and phi values were Results: significantly higher (p<0.0001), and %fPSA values significantly lower (p<0.0001) in patients with PCa. When phi was included as part of PSA screening, the model predicted a 29% reduction in negative biopsies, At univariate accuracy analysis, %p2PSA (AUC: 72.5%) and phi (AUC: 67.2%) were the most accurate and a 2% reduction in cancers detected, compared to PSA test alone. This resulted in a 30% increase predictors and significantly outperformed tPSA (AUC: 51.8%). %p2PSA significantly outperformed in testing costs, a 21% reduction in costs for diagnostics, due to the reduction of negative biopsies, and %fPSA (AUC: 60.2%) in the prediction of PCa (p≤0.001), but not phi (p=0.136). For %p2PSA a cut- a 2% reduction in total costs for prostate cancer care. Also, 6% more QALYs were gained and the cost- off of 1.68 showed the best balance between sensitivity and specificity (respectively 67.6 and 66.9%; effectiveness increased by 12%, yet 2% less life years were gained with phi versus PSA alone, due to the 95%C.I 58.8-74.3). For phi a cut-off of 40 showed the best balance between sensitivity and specificity slightly lower clinical sensitivity of phi when preceded by the PSA test. (respectively 62 and 59.6%; 95%C.I 51.3-67.5). At 90% of sensitivity, the cut-off of %p2PSA and phi Conclusions: were respectively of 1.23 and 28.8 with a specificity of 40.4 and 25.2%. At a %p2PSA cut-off of 1.23 The use of phi after a positive PSA test may reduce the number of negative biopsies and potentially improve a total of 153 (68.9%) biopsies could have been avoided; an overall of 6 PCa patients would have been the cost-effectiveness of prostate cancer screening. Further research is needed to evaluate the performance missed but only 1 (5%) patient with a Gleason score of 7 or greater would have been missed. At a phi of phi, especially for various PSA cut-offs, or the use of phi in differentiating indolent and aggressive cancers. cut-off of 28.8 a total of 116 (52.25%) biopsies could have been avoided; an overall of 6 PCa patients would have been missed but no patients with a Gleason score of 7 or greater would have been missed. Conclusions: %p2PSA and phi are more accurate than the reference standard tests (tPSA, fPSA and %fPSA) in predicting repeat prostate biopsy outcome and may be indicative of cancer aggressiveness.2 www.ProstateHealthIndex.org/EAU2012 www.ProstateHealthIndex.org/EAU2012 3
    • Abstract 278; Saturday, 25 February 2012 Abstract 909; Monday, 27 February 2012 Correlation of chronic histologic prostatic inflammation Clinical cut-offs of isoform [-2]proPSA (p2PSA) (CHPI) in biopsy specimens with serum isoform [-2] derivatives, namely %p2PSA and phi (Prostate proPSA (p2PSA), %p2PSA and phi (Prostate Health Health Index) for guiding biopsy decision in Index) in men undergoing prostate biopsy for Caucasian population suspected PCa AUTHORS: Gadda G1, Lazzeri M1, Freschi M2, Sangalli M1, Larcher A2, Scattoni V2, Lughezzani G1, AUTHORS: Lughezzani G1, Lazzeri M1, Scattoni V1, Larcher A1, Gadda G1, Nava L2, Lista G1, Bini V3, Nava L3, Buffi N1, Rigatti P1, Guazzoni G1 Freschi M4, Rigatti L1, Rigatti P1, Guazzoni G1 CENTERS: 1 University Vita-Salute San Raffaele, Department of Urology, Milan, Italy CENTERS: 1 University Vita-Salute San Raffaele, Department of Urology, Milan, Italy 2 University Vita-Salute San Raffaele, Department of Pathology, Milan, Italy 2 Fondazione “Opera S. Camillo”, Department of Urology, Milan, Italy 3 Fondazione “Opera S. Camillo”, Department of Urology, Milan, Italy 3 University, Department of Internal Medicine, Perugia, Italy 4 University Vita-Salute San Raffaele, Department of Pathology, Milan, Italy Introduction & Objectives: Introduction & Objectives: Preliminary data showed that [-2]proPSA (p2PSA) and its derivates, namely %p2PSA and phi (Prostate Preliminary results showed that the isoform [-2]proPSA (p2PSA) and its derivatives, namely %p2PSA Health Index), could discriminate between patients with or without PCa in a range of tPSA between 2.5 and phi (Prostate Health Index), are more accurate of tPSA and %fPSA in predicting prostate cancer and 10 ng/mL. We investigated the correlation between the serum p2PSA, %p2PSA and phi and chronic (PCa) at initial biopsy. The aim of this study is to translate statistical findings into clinical practice cut- histologic prostatic inflammation in men undergoing prostate biopsy for suspected PCa. offs and the percentage of biopsies that could be avoided without missing aggressive PCa. Material & Methods: Material & Methods: The analysis consisted of a nested case-control study from an observational prospective trial for the definition The study is an observational prospective analysis of sensibility, specificity and accuracy of serum of sensibility, specificity and accuracy of p2PSA, %p2PSA {(p2PSA/10)/fPSA)} and Beckman Coulter phi p2PSA, %p2PSA {([-2]proPSA/10)/fPSA)} and Beckman Coulter phi (Prostate Health Index) {[[-2] ([[-2]proPSA/fPSA] x squart PSA) in men who underwent prostatic biopsy for suspected PCa. Exclusion proPSA/fPSA] x squart PSA}, in Caucasian men referred for prostatic biopsy for suspected PCa. criteria included patients with bacterial prostatitis, previous TURP or HoLEP, patients treated with drugs that Patients with bacterial prostatitis, previous TURP or HoLEP, or treated with drugs that may alter serum may alter serum PSA levels, namely Finasteride and Dutasteride. Patients underwent ambulatory TRUS- PSA levels, namely Finasteride and Dutasteride, were excluded. All the patients underwent ambulatory guided prostate biopsies, performed according to a standardized institutional saturation scheme consisting TRUS-guided prostate biopsies, performed according to a standardized institutional saturation scheme in least 18-22 biopsy cores taken from prostate gland in order to obtain the highest detection rate. All cases consisting of at least 18-22 biopsy cores taken from prostate gland in order to obtain the highest in the cohort study that developed the outcome of interest (chronic histologic prostatic inflammation – CHPI detection rate. The primary outcome was to evaluate the clinical practice cut-off of %p2PSA and phi - defined as moderate to large infiltration of lymphomononuclear cells with interstitial and/or glandular at the best balance and at 90% of sensitivity and specificity. A secondary outcome investigated the disruption in absence of PCa) were considered the cases. p2PSA, %p2PSA and phi were considered the potential reduction of unnecessary biopsies and the characteristics of missing PCa. index tests and compared with the established biomarker reference standard tests: tPSA, fPSA, %fPSA. Results: Results: In over 664 patients, PCa cancer was found in 266 (40%) subjects. p2PSA, %p2PSA and phi values In over 664 patients, CHPI was found in 177 (26.7%) patients, benign prostatic hyperplasia (BPH) without were significantly higher (p<0.0001), and %fPSA values significantly lower (p<0.0001) in patients CHPI in 221 (33.3%) and PCa in 266 (40%). Median p2PSA (17.9 pg/ml), %p2PSA (2.07) and phi (51) with PCa. At univariate accuracy analysis, %p2PSA (AUC: 73.4%) and phi (AUC: 72.1%) were the values were significantly higher (p0.05). Median %fPSA was statistically lower in patients with PCa than most accurate predictors and significantly outperformed tPSA (AUC: 51%) and %fPSA (AUC: 62.9%) CHPI or BPH: 14.4% vs. 17.7% and 16.6% respectively (p<0.0001). in the prediction of PCa at biopsy (p≤0.001). For %p2PSA a cut-off of 1.78 showed the best balance between sensitivity and specificity (respectively 66.2 and 67.1%; 95%C.I 62.2-71.7). A cut-off of 42 Conclusions: for phi showed the best balance between sensitivity and specificity (respectively 66.5 and 66.6%; Our findings showed p2PSA, %p2PSA and phi values might discriminate patients with PCa and CHPI or 95%C.I 61.7-71.7). At 90% of sensitivity, the cut-off of %p2PSA and phi were respectively 1.26 and BPH, but not CHPI than BPH. As tPSA failed to distinguish PCa, BPH and CHPI, isoform p2PSA and its 30 with a specificity of 35.4 and 29.1%. At a %p2PSA cut-off of 1.26 a total of 123 (18.5%) biopsies derivates could be useful in biopsy clinical decision making in order to prevent unnecessary biopsies in could have been avoided, but 7 (5.4%) cancers with a Gleason score of 7 or greater would have been patients with CHPI and elevated tPSA value. missed. At a phi cut-off of 30 a total of 125 (18.9%) biopsies could have been avoided and 5 (3.8%) cancers with a Gleason score of 7 or greater would have been missed.4 www.ProstateHealthIndex.org/EAU2012 www.ProstateHealthIndex.org/EAU2012 5
    • Abstract 910; Monday, 27 February 2012 Abstract 912; Monday, 27 February 2012 Comparison of phi (Prostate Health Index) and PCA3 Isoform [-2]proPSA (p2PSA) and its derivates, %p2PSA assay in the prediction of prostate biopsy (PBx) outcome and phi values differ between BPH, ASAP, HG-PIN in patients who have undergone initial and repeated and PCa in a set of contemporary men prostatic biopsies undergoing prostate biopsy AUTHORS: Scattoni V1, Lazzeri M1, De Luca S2, Bollito E2, Randone D2, Lughezzani G1, Larcher A1, Lista G1, Gadda G1, Maccagnano C1, Rigatti P1, Guazzoni G1 AUTHORS: Lista G1, Lughezzani G1, Lazzeri M1, Scattoni V1, Nava L2, Centemero A1, Losa A1, Fabbri F1, CENTERS: 1 University Vita-Salute, Department of Urology, Milan, Italy Bini V3, Rigatti P1, Guazzoni G1 2 Ospedale Gradenigo, Department of Urology, Turin, Italy CENTERS: 1 University Vita-Salute San Raffaele, Department of Urology, Milan, Italy Introduction & Objectives: 2 Fondazione “Opera S. Camillo”, Department of Urology, Milan, Italy 3 University of Perugia, Department of Internal Medicine, Perugia, Italy To compare the diagnostic performance of Beckman Coulter phi and PCA3-Score in men undergoing first and repeat extended PBx. Introduction & Objectives: Preliminary data showed that p2PSA and its derivates, %p2PSA and phi (Prostate Health Index), could Material & Methods: discriminate between patients with or without PCa in a range of tPSA between 2.0 and 10 ng/mL. To The diagnostic performance of phi [(p2PSA/fPSA) x √tPSA)] and PCA3 across different PSA date there have been no published studies which characterized p2PSA, %p2PSA and phi in patients ranges was evaluated in a combined dataset of 194 men (median age 67 yrs, median PSA: 6.4 ng/ with benign prostatic hyperplasia (BPH), high-grade prostate intraepithelial neoplasia (HGPIN), atypical ml±6.9) undergoing first (n=155 cases) or (multiple) repeat PBx (n=39 cases) (12-22 cores) in two small acinar proliferation (ASAP) and prostate cancer. We tested the hypothesis that p2PSA and its centers. Both tests were performed prior to DRE and PBx. The blood samples were processed using derivates may accurately discriminate between BPH, HG-PIN, ASAP and PCa in a set of contemporary UniCel DxI 800 Immunoassay System analyzer (Beckman Coulter, Brea, CA, USA). The PCA3 score men undergoing prostate biopsy. was determined by the PROGENSA PCA3 assay. phi and PCA3 were compared to age, total PSA, prostate volume, DRE, PSA density (PSAD), and %fPSA. Statistical analysis encompassed descriptive Material & Methods: statistics, nonparametric analysis of differences in PBx+ vs. PBx- men, ROC-Analysis and calculation The study design consisted of an observational prospective cohort study for the definition of sensibility, of specificity at a sensitivity of 80% and sensitivity at a specificity of 50%. specificity and accuracy of serum p2PSA, %p2PSA {([p2PSA/fPSA x 1000]x100)} and Beckman Coulter phi (Prostate Health Index) {[[-2]proPSA/fPSA] x squart PSA}, in men referred for prostatic Results: biopsy. Exclusion criteria included patients with bacterial prostatitis, previous TURP or HoLEP, patients Cancer was detected in 63/194 patients (32.4 %) in the whole group (33.1% and 28.9% in the treated with drugs that may alter serum PSA levels, namely finasteride and dutasteride. Patients initial and repeat group, respectively). Only phi (43.8 vs 65.13; p= 0.01) and prostate volume (86.1 vs underwent ambulatory TRUS-guided prostate biopsies, performed according to a standardized 60.1; p=0.04) were significantly different between Bx- and Bx+ men in the whole group. In the initial institutional saturation scheme consisting of at least 18-22 biopsy cores taken from prostate gland setting, age (65.8 vs 68.7; p=0.02), PCA3 score (48.2 vs 63.9; p= 0.04), phi (45.2 vs 67.7; p=0.04) in order to obtain the highest detection rate. The primary endpoint of the study was to determine and prostate volume (86.6 vs 56.6; p=0.04) were significantly different between PBx- and PBx+ men. the diagnostic accuracy of p2PSA, %p2PSA and phi (index tests) compared with the accuracy of On the contrary, no significant differences were found in the parameters in the repeat setting. The established PCa predictors (tPSA, fPSA, %fPSA and PSAD) (reference standard tests). ROC-Analysis showed phi had the highest AUC value in the whole group (0.678) and significantly higher compared to PCA3 (0.544) (p=0.02), and tPSA (0.516) (p=0.003), age (0.53) (p= 0.02), but Results: not %fPSA (0.60) and PSAD (0.57). Likewise, in the initial setting, AUC was highest for phi (0.68) In over 664 patients, a prostate biopsy detected cancer in 266 (40%) patients, BPH in 339 (51%), followed by %fPSA (0.62) PCA3 (0.60), age (0.57), PSA (0.53), PSAD (0.641) and %fPSA (0.608). HGPIN in 43 (6.5%%) and ASAP in 16 (2.5%) of subjects. p2PSA (17.96 pg/ml), %p2PSA (2.07) On the contrary, in the repeat setting, AUC was highest for PCA3 (0.67) compared to phi (0.60) and phi (51) values were significantly higher (p<0.0001), and %fPSA (0.14) values significantly lower %fPSA (0.55), tPSA (0.54) and age (0.64) even if no statistically significant difference was found. In (p<0.0001) in patients with PCa vs. no cancer patients. Patients with PCa were statistically older (66.7 the whole group, with a sensitivity set at 80%, specificity for phi and PCA3 was 36.15% and 20%, yrs.) than BPH ones (62.8 yrs) (p<0.0001), but not in HG-PIN (66.7 yrs.) (p=0.975) or ASAP (65.6 respectively. In the initial setting a 12.3% increase of phi compared to PCA3 was found. In the repeat yrs.) (p=0.948). No significant difference was observed for the median value of %p2PSA and phi setting, a 15.0% increase of specificity of PCA3 compared to phi was reported. At a specificity of 50%, between patients with BPH, HG-PIN and ASAP (1.44; 1.53 and 1.78; 36.8; 39 and 40.5 respectively), sensitivity for phi and PCA3 were 74.5% and 62.5% in the initial setting and 63.3% and 62.8% in the and between PCa and ASAP patients (p=0.493; p=0.219). repeat setting, respectively. Conclusions: Conclusions: %p2PSA and phi values may discriminate patients with PCa from patients with BPH and HG-PIN, but phi seems to be the strongest parameter to predict PBx outcome in the initial setting, while PCA3 fail to distinguish them from ASAP subjects. Further multicentric international studies are mandatory to seems to be more accurate than phi in the repeat setting. confirm our findings.6 www.ProstateHealthIndex.org/EAU2012 www.ProstateHealthIndex.org/EAU2012 7