The critical role of the pathologist in determining eligibility for active survlnc. as a mgmt. option in patients with prostate cancer: Consensus statement with recommendations supported by the Coll. of Amer. Pathologists, Intl. Soc. of Urological Pathol., Assoc. of Directors of Anat. and Surg. Pathol., the New Zealand Soc. of Pathologists, and the Prostate Cancer Found.

Archives of Pathology and Laboratory Medicine

Volumn 138, Issue 10, 2014, Pages 1387-1405

  Amin, Mahul B ^a   Lin, Daniel W ^b   Gore, John L ^b   Srigley, John R ^d,e   Samaratunga, Hema ^f,g   Egevad, Lars ^h   Rubin, Mark ^i,j   Nacey, John ^k   Carter, H Ballentine ^l   Klotz, Laurence ^m   Sandler, Howard ^a   Zietman, Anthony L ^o   Holden, Stuart ^a   Montironi, Rodolfo ^p   Humphrey, Peter A ^q   Evans, Andrew J ⁿ   Epstein, Jonathan I ^l   Delahunt, Brett ^k   McKenney, Jesse K ^r   Berney, Dan ^s   Wheeler, Thomas M ^t   Chinnaiyan, Arul M ^u   True, Lawrence ^c   Knudsen, Beatrice ^a   Hammond, M Elizabeth H ^v   more..

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d CREDIT VALLEY HOSPITAL   (Canada)

^e MCMASTER UNIVERSITY   (Canada)

^f Aquesta Pathology   (Australia)

^g UNIVERSITY OF QUEENSLAND   (Australia)

^h KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

ⁱ WEILL CORNELL MEDICAL COLLEGE   (United States)

^j NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^k UNIVERSITY OF OTAGO   (New Zealand)

^l JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^m UNIVERSITY OF TORONTO   (Canada)

ⁿ UNIVERSITY HEALTH NETWORK   (Canada)

^o HARVARD MEDICAL SCHOOL   (United States)

^p UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^q YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^r LERNER RESEARCH INSTITUTE   (United States)

^s ROYAL LONDON HOSPITAL   (United Kingdom)

^t BAYLOR COLLEGE OF MEDICINE   (United States)

^u UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^v UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD; CANCER GRADING; CANCER STAGING; CONSENSUS DEVELOPMENT; EVIDENCE BASED MEDICINE; HEALTH CARE ORGANIZATION; HEALTH SERVICE; HUMAN; INTERNATIONAL COOPERATION; MALE; MANPOWER; NEEDLE BIOPSY; NEW ZEALAND; PATHOLOGY; PRACTICE GUIDELINE; PRECANCEROUS CONDITIONS; PROFESSIONAL STANDARD; PROSTATE; PROSTATIC NEOPLASMS; RISK; TUMOR VOLUME; UNITED STATES; WATCHFUL WAITING;

BIOPSY, NEEDLE; EVIDENCE-BASED MEDICINE; HUMANS; INTERNATIONAL AGENCIES; MALE; NEOPLASM GRADING; NEOPLASM STAGING; NEW ZEALAND; PATHOLOGY, CLINICAL; PRACTICE GUIDELINES AS TOPIC; PRECANCEROUS CONDITIONS; PROFESSIONAL ROLE; PROSTATE; PROSTATIC NEOPLASMS; RISK; SOCIETIES, SCIENTIFIC; TUMOR BURDEN; UNITED STATES; VOLUNTARY HEALTH AGENCIES; WATCHFUL WAITING;

EID: 84907652150     PISSN: 00039985     EISSN: 15432165     Source Type: Journal    
DOI: 10.5858/arpa.2014-0219-SA     Document Type: Article

References (177)

1. Ganz PA, Barry JM, Burke W, et al. NIH state-of-the-science conference statement: role of active surveillance in the management of men with localized prostate cancer. NIH Consens State Sci Statements. 2011;28(1):1-27.
2. Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011;61(4):212-236.
3. Cooperberg MR, Broering JM, Litwin MS, et al; CaPSURE Investigators. The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CaPSURE), a national disease registry. J Urol. 2004;171(4):1393-1401.
4. Albertsen PC, Hanley JA, Fine J. 20-year outcomes following conservative management of clinically localized prostate cancer. JAMA. 2005;293(17):2095-2101.
5. Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol. 2010;28(7):1117-1123.
6. Etzioni R, Penson DF, Legler JM, et al. Overdiagnosis due to prostate-specific antigen screening: lessons from U.S. prostate cancer incidence trends. J Natl Cancer Inst. 2002;94(13):981-990.
7. Johansson JE, Andrén O, Andersson SO, et al. Natural history of early, localized prostate cancer. JAMA. 2004;291(22):2713-2719.
8. McGregor M, Hanley JA, Boivin JF, McLean RG. Screening for prostate cancer: estimating the magnitude of overdetection. CMAJ. 1998;159(11):1368-1372.
9. Etzioni R, Tsodikov A, Mariotto A, et al. Quantifying the role of PSA screening in the US prostate cancer mortality decline. Cancer Causes Control. 2008;19(2):175-181.
10. Andriole GL, Grubb RL III, Buys SS, et al PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009; 360(13):1310-1319.
11. Schröder FH, Hugosson J, Roobol MJ, et al; ERSPC Investigators. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360(13):1320-1328.
12. Zeliadt SB, Hoffman RM, Etzioni R, Gore JL, Kessler LG, Lin DW. Influence of publication of US and European prostate cancer screening trials on PSA testing practices. J Natl Cancer Inst. 2011;103(6):520-523.
13. Moyer VA; for U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(2):120-134.
14. Wilt TJ, Brawer MK, Jones KM, et al Prostate Cancer Intervention Versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367(3):203-213.
15. Schwartz LM, Woloshin S, Fowler FJ Jr, Welch HG. Enthusiasm for cancer screening in the United States. JAMA. 2004;291(1):71-78.
16. Ganz PA, Barry JM, Burke W, et al. National Institutes of Health state-of-the-science conference: role of active surveillance in the management of men with localized prostate cancer. Ann Intern Med. 2012;156(8):591-595.
17. Basch E, Oliver TK, Vickers A, et al. Screening for prostate cancer with prostate-specific antigen testing: American Society of Clinical Oncology provisional clinical opinion. J Clin Oncol. 2012;30(24):3020-3025.
18. Cooperberg MR, Broering JM, Kantoff PW, Carroll PR. Contemporary trends in low risk prostate cancer: risk assessment and treatment. J Urol. 2007; 178(3, pt 2):S14-S19.
19. Miller DC, Gruber SB, Hollenbeck BK, Montie JE, Wei JT. Incidence of initial local therapy among men with lower-risk prostate cancer in the United States. J Natl Cancer Inst. 2006;98(16):1134-1141.
20. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013;63(1):11-30.
21. D'Amico AV, Whittington R, Malkowicz SB, et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998;280(11): 969-974.
22. Mohler J, Bahnson RR, Boston B, et al. NCCN clinical practice guidelines in oncology: prostate cancer. J Natl Compr Canc Netw. 2010;8(2):162-200.
23. Lu-Yao GL, Albertsen PC, Moore DF, et al. Outcomes of localized prostate cancer following conservative management. JAMA. 2009;302(11):1202-1209.
24. Heidenreich A, Bellmunt J, Bolla M, et al European Association of Urology. EAU guidelines on prostate cancer, part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011;59(1):61-71.
25. Thompson I, Thrasher JB, Aus G, et al AUA Prostate Cancer Clinical Guideline Update Panel. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol. 2007;177(6):2106-2131.
26. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: prostate cancer [behind firewall]. http://www.nccn.org/professionals/physician-gls/pdf/prostate.pdf. Updated 2010. Accessed April 8, 2014.
27. Dall'Era MA, Cooperberg MR, Chan JM, et al. Active surveillance for early-stage prostate cancer: review of the current literature. Cancer. 2008;112(8): 1650-1659.
28. Xia J, Trock BJ, Cooperberg MR, et al. Prostate cancer mortality following active surveillance versus immediate radical prostatectomy. Clin Cancer Res. 2012;18(19):5471-5478.
29. Parker C. Active surveillance: towards a new paradigm in the management of early prostate cancer. Lancet Oncol. 2004;5(2):101-106.
30. Klotz L, Zhang L, Lam A, Nam R, Mamedov A, Loblaw A. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol. 2010;28(1):126-131.
31. Cooperberg MR, Cowan JE, Hilton JF, et al. Outcomes of active surveillance for men with intermediate-risk prostate cancer. J Clin Oncol. 2011; 29(2):228-234.
32. Carter HB, Kettermann A, Warlick C, et al. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007;178(6):2359-2365.
33. Celma DA, Planas MJ, Morote RJ. Optimization of follow up in prostate cancer active surveillance. Arch Esp Urol. 2014;67(5):442-451.
34. Le JD, Huang J, Marks LS. Targeted prostate biopsy: value of multi-parametric magnetic resonance imaging in detection of localized cancer [published online ahead of print February 28, 2014]. Asian J Androl. doi:10. 4103/1008-682X.122864.
35. Rastinehad AR, Turkbey B, Salami SS, et al. Improving detection of clinically significant prostate cancer: magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy [published online ahead of print December 12, 2013]. J Urol. pii:S0022-5347(13)06089-8. doi:10.1016/j.juro.2013.12.007.
36. Meng MV, Elkin EP, Harlan SR, Mehta SS, Lubeck DP, Carroll PR. Predictors of treatment after initial surveillance in men with prostate cancer: results from CaPSURE. J Urol. 2003;170(6, pt 1):2279-2283.
37. Stephenson AJ, Aprikian AG, Souhami L, et al. Utility of PSA doubling time in follow-up of untreated patients with localized prostate cancer. Urology. 2002;59(5):652-656.
38. Zietman AL, Thakral H, Wilson L, Schellhammer P. Conservative management of prostate cancer in the prostate specific antigen era: the incidence and time course of subsequent therapy. J Urol. 2001;166(5):1702-1706.
39. Ross AE, Loeb S, Landis P, et al. Prostate-specific antigen kinetics during follow-up are an unreliable trigger for intervention in a prostate cancer surveillance program. J Clin Oncol. 2010;28(17):2810-2816.
40. D'Amico AV, Chen MH, Roehl KA, Catalona WJ. Preoperative PSA velocity and the risk of death from prostate cancer after radical prostatectomy. N Engl J Med. 2004;351(2):125-135.
41. Freedland SJ, Humphreys EB, Mangold LA, et al. Risk of prostate cancerspecific mortality following biochemical recurrence after radical prostatectomy. JAMA. 2005;294(4):433-439.
42. Khatami A, Aus G, Damber JE, Lilja H, Lodding P, Hugosson J. PSA doubling time predicts the outcome after active surveillance in screening-detected prostate cancer: results from the European randomized study of screening for prostate cancer, Sweden section. Int J Cancer. 2007;120(1):170- 174.
43. Loblaw A, Zhang L, Lam A, et al. Comparing prostate specific antigen triggers for intervention in men with stable prostate cancer on active surveillance. J Urol. 2010;184(5):1942-1946.
44. Zhang L, Loblaw A, Klotz L. Modeling prostate specific antigen kinetics in patients on active surveillance. J Urol. 2006;176(4, pt 1):1392-1397; discussion 1397-1398.
45. Berglund RK, Masterson TA, Vora KC, Eggener SE, Eastham JA, Guillonneau BD. Pathological upgrading and up staging with immediate repeat biopsy in patients eligible for active surveillance. J Urol. 2008;180(5):1964-1967; discussion 1967-1968.
46. Sundi D, Ross AE, Humphreys EB, et al. African American men with very low-risk prostate cancer exhibit adverse oncologic outcomes after radical prostatectomy: should active surveillance still be an option for them? J Clin Oncol. 2013;31(24):2991-2997.
47. Hodge KK, McNeal JE, Terris MK, Stamey TA. Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate. J Urol. 1989; 142(1):71-74; discussion 74-75.
48. Latini DM, Hart SL, Knight SJ, et al; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol. 2007;178(3, pt 1):826-831; discussion 831-822.
49. Chen RC, Clark JA, Manola J, Talcott JA. Treatment 'mismatch' in early prostate cancer: do treatment choices take patient quality of life into account? Cancer. 2008;112(1):61-68.
50. Manoharan M, Eldefrawy A, Katkoori D, Antebi E, Soloway MS. Comparison of urologist reimbursement for managing patients with low-risk prostate cancer by active surveillance versus total prostatectomy. Prostate Cancer Prostatic Dis. 2010;13(4):307-310.
51. Hamilton AS, Wu XC, Lipscomb J, et al. Regional, provider, and economic factors associated with the choice of active surveillance in the treatment of men with localized prostate cancer. J Natl Cancer Inst Monogr. 2012; 2012(45):213-220.
52. Glass AS, Cooperberg MR, Meng MV, Carroll PR. Role of active surveillance in the management of localized prostate cancer. J Natl Cancer Inst Monogr. 2012;2012(45):202-206.
53. Karram S, Trock BJ, Netto GJ, Epstein JI. Should intervening benign tissue be included in the measurement of discontinuous foci of cancer on prostate needle biopsy?: correlation with radical prostatectomy findings. Am J Surg Pathol. 2011;35(9):1351-1355.
54. Soloway MS, Soloway CT, Williams S, Ayyathurai R, Kava B, Manoharan M. Active surveillance; a reasonable management alternative for patients with prostate cancer: the Miami experience. BJU int. 2008;101(2):165-169.
55. Dall'Era MA, Konety BR, Cowan JE, et al. Active surveillance for the management of prostate cancer in a contemporary cohort. Cancer. 2008;112(12): 2664-2670.
56. Draisma G, Boer R, Otto SJ, et al. Lead times and overdetection due to prostate-specific antigen screening: estimates from the European Randomized Study of Screening for Prostate Cancer. J Natl Cancer Inst. 2003;95(12):868-878.
57. Mahamud O, van der Kwast TH, Downes MR, Downes AJ. Assessing the extent of biopsy core involvement by prostate cancer and its impact on the selection of patients for active surveillance: is "eyeballing" accurate enough [abstract]? Mod Pathol. 2013;26(suppl 2s):232A. doi:10.1038/modpathol.2013.12.
58. Epstein JI. Prognostic significance of tumor volume in radical prostatectomy and needle biopsy specimens. J Urol. 2011;186(3):790-797.
59. Quintal MM, Meirelles LR, Freitas LL, Magna LA, Ferreira U, Billis A. Various morphometric measurements of cancer extent on needle prostatic biopsies: which is predictive of pathologic stage and biochemical recurrence following radical prostatectomy? Int Urol Nephrol. 2011;43(3):697-705.
60. Bismar TA, Lewis JS Jr, Vollmer RT, Humphrey PA. Multiple measures of carcinoma extent versus perineural invasion in prostate needle biopsy tissue in prediction of pathologic stage in a screening population. Am J Surg Pathol. 2003; 27(4):432-440.
61. Park EA, Lee HJ, Kim KG, Kim SH, Lee SE, Choe GY. Prediction of pathological stages before prostatectomy in prostate cancer patients: analysis of 12 systematic prostate needle biopsy specimens. Int J Urol. 2007;14(8):704-708.
62. Brimo F, Vollmer RT, Corcos J, et al. Prognostic value of various morphometric measurements of tumour extent in prostate needle core tissue. Histopathology. 2008;53(2):177-183.
63. Poulos CK, Daggy JK, Cheng L. Prostate needle biopsies: multiple variables are predictive of final tumor volume in radical prostatectomy specimens. Cancer. 2004;101(3):527-532.
64. Sebo TJ, Cheville JC, Riehle DL, et al. Predicting prostate carcinoma volume and stage at radical prostatectomy by assessing needle biopsy specimens for percent surface area and cores positive for carcinoma, perineural invasion, Gleason score, DNA ploidy and proliferation, and preoperative serum prostate specific antigen: a report of 454 cases. Cancer. 2001;91(11):2196-2204.
65. Sebo TJ, Bock BJ, Cheville JC, Lohse C, Wollan P, Zincke H. The percent of cores positive for cancer in prostate needle biopsy specimens is strongly predictive of tumor stage and volume at radical prostatectomy. J Urol. 2000; 163(1):174-178.
66. Lewis JS Jr, Vollmer RT, Humphrey PA. Carcinoma extent in prostate needle biopsy tissue in the prediction of whole gland tumor volume in a screening population. Am J Clin Pathol. 2002;118(3):442-450.
67. Egevad L, Allsbrook WC Jr, Epstein JI. Current practice of diagnosis and reporting of prostate cancer on needle biopsy among genitourinary pathologists. Hum Pathol. 2006;37(3):292-297.
68. Berney DM, Algaba F, Camparo P, et al. Variation in reporting of cancer extent and benign histology in prostate biopsies among European pathologists [published online ahead of print May 2014]. Virchows Arch. 2014;464(5):583- 587.doi:10.1007/s00428-014-1554-1.
69. Descazeaud A, Rubin MA, Allory Y, et al. What information are urologists extracting from prostate needle biopsy reports and what do they need for clinical management of prostate cancer? Eur Urol. 2005;48(6):911-915.
70. Rubin MA, Bismar TA, Curtis S, Montie JE. Prostate needle biopsy reporting: how are the surgical members of the Society of Urologic Oncology using pathology reports to guide treatment of prostate cancer patients? Am J Surg Pathol. 2004;28(7):946-952.
71. D'Amico AV, Whittington R, Malkowicz SB, et al. Biochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen era. Cancer. 2002;95(2):281-286.
72. Srigley JR, Humphrey PA, Amin MB, et al Members of the Cancer Committee, College of American Pathologists. Protocol for the examination of specimens from patients with carcinoma of the prostate gland. Arch Pathol Lab Med. 2009;133(10):1568-1576.
73. Epstein JI, Srigley J, Grignon D, Humphrey P; Association of Directors of Anatomic and Surgical Pathology. Recommendations for the reporting of prostate carcinoma. Hum Pathol. 2007;38(9):1305-1309.
74. Amin M, Boccon-Gibod L, Egevad L, et al. Prognostic and predictive factors and reporting of prostate carcinoma in prostate needle biopsy specimens. Scand J Urol Nephrol Suppl. 2005(216):20-33.
75. Humphrey PA. Tumor amount in prostatic tissues in relation to patient outcome and management. Am J Clin Pathol. 2009;131(1):7-10.
76. Dall'Era MA, Albertsen PC, Bangma C, et al. Active surveillance for prostate cancer: a systematic review of the literature. Eur Urol. 2012;62(6):976-983.
77. Epstein JI, Potter SR. The pathological interpretation and significance of prostate needle biopsy findings: implications and current controversies. J Urol. 2001;166(2):402-410.
78. Schultz L, Maluf CE, da Silva RC, Falashi Rde H, da Costa MV, Schultz MI. Discontinuous foci of cancer in a single core of prostatic biopsy: when it occurs and performance of quantification methods in a private-practice setting. Am J Surg Pathol. 2013;37(12):1831-1836.
79. Kryvenko ON, Carter HC, Trock BJ, Epstein JI. Biopsy criteria for determining appropriateness for active surveillance in the modern era. Urology. 2014;83(4):869-874.
80. Fajardo DA, Epstein JI. Fragmentation of prostatic needle biopsy cores containing adenocarcinoma: the role of specimen submission. BJU Int. 2010; 105(2):172-175.
81. Kao J, Upton M, Zhang P, Rosen S. Individual prostate biopsy core embedding facilitates maximal tissue representation. J Urol. 2002;168(2):496-499.
82. Eble JN, Sauter G, Epstein JI, Sesterhenn IA. Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs. Lyon, France: IARC Press; 2004. World Health Organization Classification of Tumours; vol 6.
83. Elharram M, Margel D, Finelli A, et al. Perineural invasion on prostate biopsy does not predict adverse pathological outcome. Can J Urol. 2012;19(6): 6567-6572.
84. Loeb S, Epstein JI, Humphreys EB, Walsh PC. Does perineural invasion on prostate biopsy predict adverse prostatectomy outcomes? BJU Int. 2010;105(11): 1510-1513.
85. Al-Hussain T, Carter HB, Epstein JI. Significance of prostate adenocarcinoma perineural invasion on biopsy in patients who are otherwise candidates for active surveillance. J Urol. 2011;186(2):470-473.
86. Iczkowski KA. Current prostate biopsy interpretation: criteria for cancer, atypical small acinar proliferation, high-grade prostatic intraepithelial neoplasia, and use of immunostains. Arch Pathol Lab Med. 2006;130(6):835-843.
87. Merrimen JL, Jones G, Hussein SA, Leung CS, Kapusta LR, Srigley JR. A model to predict prostate cancer after atypical findings in initial prostate needle biopsy. J Urol. 2011;185(4):1240-1245.
88. Samaratunga H, Gardiner RA, Yaxley J, Brown I. Atypical prostatic glandular proliferations on needle biopsy: diagnostic implications, use of immunohistochemistry, and clinical significance. Anal Quant Cytol Histol. 2006;28(2):104-110.
89. Montironi R, Scattoni V, Mazzucchelli R, Lopez-Beltran A, Bostwick DG, Montorsi F. Atypical foci suspicious but not diagnostic of malignancy in prostate needle biopsies (also referred to as "atypical small acinar proliferation suspicious for but not diagnostic of malignancy"). Eur Urol. 2006;50(4):666-674.
90. Epstein JI, Herawi M. Prostate needle biopsies containing prostatic intraepithelial neoplasia or atypical foci suspicious for carcinoma: implications for patient care. J Urol. 2006;175(3, pt 1):820-834.
91. Shah RB, Kunju LP, Shen R, LeBlanc M, Zhou M, Rubin MA. Usefulness of basal cell cocktail (34βE12 + p63) in the diagnosis of atypical prostate glandular proliferations. Am J Clin Pathol. 2004;122(4):517-523.
92. Epstein JI, Allsbrook WC Jr, Amin MB, Egevad LL; ISUP Grading Committee. The 2005 International Society of Urological Pathology (ISUP) consensus conference on Gleason grading of prostatic carcinoma. Am J Surg Pathol. 2005;29(9):1228-1242.
93. Epstein JI, Walsh PC, Carmichael M, Brendler CB. Pathologic and clinical findings to predict tumor extent of nonpalpable (stage T1c) prostate cancer. JAMA. 1994;271(5):368-374.
94. Ohori M, Kattan MW, Koh H, et al. Predicting the presence and side of extracapsular extension: a nomogram for staging prostate cancer. J Urol. 2004; 171(5):1844-1849; discussion 1849.
95. Eggener SE, Scardino PT, Carroll PR, et al International Task Force on Prostate Cancer and the Focal Lesion Paradigm. Focal therapy for localized prostate cancer: a critical appraisal of rationale and modalities. J Urol. 2007; 178(6):2260-2267.
96. Ross HM, Kryvenko ON, Cowan JE, Simko JP, Wheeler TM, Epstein JI. Do adenocarcinomas of the prostate with Gleason score (GS) ≤6 have the potential to metastasize to lymph nodes? Am J Surg Pathol. 2012;36(9):1346-1352.
97. Mitchell RE, Shah JB, Desai M, et al. Changes in prognostic significance and predictive accuracy of Gleason grading system throughout PSA era: impact of grade migration in prostate cancer. Urology. 2007;70(4):706-710.
98. Billis A, Guimaraes MS, Freitas LL, Meirelles L, Magna LA, Ferreira U. The impact of the 2005 International Society of Urological Pathology consensus conference on standard Gleason grading of prostatic carcinoma in needle biopsies. J Urol. 2008;180(2):548-552; discussion 552-543.
99. Delahunt B, Lamb DS, Srigley JR, et al. Gleason scoring: a comparison of classical and modified (International Society of Urological Pathology) criteria using nadir PSA as a clinical end point. Pathology. 2010;42(4):339-343.
100. Helpap B, Egevad L. The significance of modified Gleason grading of prostatic carcinoma in biopsy and radical prostatectomy specimens. Virchows Arch. 2006;449(6):622-627.
101. Kuroiwa K, Uchino H, Yokomizo A, Naito S. Impact of reporting rules of biopsy Gleason score for prostate cancer. J Clin Pathol. 2009;62(3):260-263.
102. Ozok HU, Sagnak L, Tuygun C, et al. Will the modification of the Gleason grading system affect the urology practice? Int J Surg Pathol. 2010;18(4):248-254.
103. Tsivian M, Sun L, Mouraviev V, et al. Changes in Gleason score grading and their effect in predicting outcome after radical prostatectomy. Urology. 2009; 74(5):1090-1093.
104. Danneman D, Drevin L, Robinson D, Stattin P, Egevad L. Gleason inflation 1998-2011. a registry study of 97 168 men [published online ahead of print February 19, 2014]. BJU Int. doi:10.1111/bju.12671.
105. Epstein JI. The Gleason Grading System. A Complete Guide for Pathologists and Clinicians. Philadelphia, PA: Lippincott Williams & Wilkins; 2013.
106. Dong F, Wang C, Farris AB, et al. Impact on the clinical outcome of prostate cancer by the 2005 International Society of Urological Pathology modified Gleason grading system. Am J Surg Pathol . 2012;36(6):838-843.
107. Iczkowski KA, Torkko KC, Kotnis GR, et al. Digital quantification of five high-grade prostate cancer patterns, including the cribriform pattern, and their association with adverse outcome. Am J Clin Pathol. 2011;136(1):98-107.
108. O'Brien C, True LD, Higano CS, Rademacher BL, Garzotto M, Beer TM. Histologic changes associated with neoadjuvant chemotherapy are predictive of nodal metastases in patients with high-risk prostate cancer. Am J Clin Pathol. 2010;133(4):654-661.
109. Epstein JI. An update of the Gleason grading system. J Urol. 2010;183(2): 433-440.
110. Brimo F, Montironi R, Egevad L, et al. Contemporary grading for prostate cancer: implications for patient care. Eur Urol. 2013;63(5):892-901.
111. Pierorazio PM, Walsh PC, Partin AW, Epstein JI. Prognostic Gleason grade grouping: data based on the modified Gleason scoring system. BJU int . 2013; 111(5):753-760.
112. Egevad L, Allsbrook WC Jr, Epstein JI. Current practice of Gleason grading among genitourinary pathologists. Hum Pathol. 2005;36(1):5-9.
113. Egevad L, Ahmad AS, Algaba F, et al. Standardization of Gleason grading among 337 European pathologists. Histopathology. 2013;62(2):247-256.
114. Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009;101(21):1446-1452.
115. Shariat SF, Karakiewicz PI, Margulis V, Kattan MW. Inventory of prostate cancer predictive tools. Curr Opin Urol. 2008;18(3):279-296.
116. Kattan MW, Eastham JA, Stapleton AM, Wheeler TM, Scardino PT. A preoperative nomogram for disease recurrence following radical prostatectomy for prostate cancer. J Natl Cancer Inst. 1998;90(10):766-771.
117. Mitchell JA, Cooperberg MR, Elkin EP, et al. Ability of 2 pretreatment risk assessment methods to predict prostate cancer recurrence after radical prostatectomy: data from CaPSURE. J Urol. 2005;173(4):1126-1131.
118. Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin tables) for the new millennium. Urology. 2001;58(6):843-848.
119. Kattan MW, Vickers AJ, Yu C, et al. Preoperative and postoperative nomograms incorporating surgeon experience for clinically localized prostate cancer. Cancer. 2009;115(5):1005-1010.
120. Kattan MW, Eastham JA, Wheeler TM, et al. Counseling men with prostate cancer: a nomogram for predicting the presence of small, moderately differentiated, confined tumors. J Urol . 2003;170(5):1792-1797.
121. Steyerberg EW, Roobol MJ, Kattan MW, van der Kwast TH, de Koning HJ, Schröder FH. Prediction of indolent prostate cancer: validation and updating of a prognostic nomogram. J Urol. 2007;177(1):107-112.
122. Glinsky GV, Berezovska O, Glinskii AB. Microarray analysis identifies a death-from-cancer signature predicting therapy failure in patients with multiple types of cancer. J Clin Invest. 2005;115(6):1503-1521.
123. Singh D, Febbo PG, Ross K, et al. Gene expression correlates of clinical prostate cancer behavior. Cancer Cell. 2002;1(2):203-209.
124. Lapointe J, Li C, Higgins JP, et al. Gene expression profiling identifies clinically relevant subtypes of prostate cancer. Proc Natl Acad Sci U S A. 2004; 101(3):811-816.
125. Yu YP, Landsittel D, Jing L, et al. Gene expression alterations in prostate cancer predicting tumor aggression and preceding development of malignancy. J Clin Oncol. 2004;22(14):2790-2799.
126. Penney KL, Sinnott JA, Fall K, et al. mRNA expression signature of Gleason grade predicts lethal prostate cancer. J Clin Oncol . 2011;29(17):2391- 2396.
127. Sotiriou C, Wirapati P, Loi S, et al. Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis. J Natl Cancer Inst. 2006;98(4):262-272.
128. van de Vijver MJ, He YD, van't Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002;347(25):1999- 2009.
129. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27): 2817-2826.
130. Fan C, Oh DS, Wessels L, et al. Concordance among gene-expression-based predictors for breast cancer. N Engl J Med. 2006;355(6):560-569.
131. Carlson RW, Allred DC, Anderson BO, et al NCCN Breast Cancer Clinical Practice Guidelines Panel. Breast cancer: clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2009;7(2):122-192.
132. Hornberger J, Alvarado MD, Rebecca C, Gutierrez HR, Yu TM, Gradishar WJ. Clinical validity/utility, change in practice patterns, and economic implications of risk stratifiers to predict outcomes for early-stage breast cancer: a systematic review. J Natl Cancer Inst. 2012;104(14):1068-1079.
133. Hornberger J, Chien R. Meta-analysis of the decision impact of the 21-gene breast cancer recurrence score® in clinical practice [Abstract]. In: Proceedings from the 33rd San Antonio Breast Cancer Symposium; December 8-12, 2010; San Antonio, TX. Abstract 20609.
134. Bishoff JT, Freedland SJ, Gerber L, et al. Prognostic utility of the CCP score generated from biopsy in men treated with prostatectomy [publishing online ahead of print February 7, 2014]. J Urol. pii:S0022-5347(14)00248-1. doi:10.1016/j.juro.2014.02.003.
135. Cooperberg MR, Simko JP, Cowan JE, et al. Validation of a cell-cycle progression gene panel to improve risk stratification in a contemporary prostatectomy cohort. J Clin Oncol. 2013;31(11):1428-1434.
136. Cuzick J, Berney DM, Fisher G, et al Transatlantic Prostate Group. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 2012;106(6):1095-1099.
137. Cuzick J, Swanson GP, Fisher G, et al Transatlantic Prostate Group. Prognostic value of an RNA expression signature derived from cell cycle proliferation genes in patients with prostate cancer: a retrospective study. Lancet Oncol . 2011;12(3):245-255.
138. True L, Coleman I, Hawley S, et al. A molecular correlate to the Gleason grading system for prostate adenocarcinoma. Proc Natl Acad Sci U S A. 2006; 103(29):10991-10996.
139. Berger MF, Lawrence MS, Demichelis F, et al. The genomic complexity of primary human prostate cancer. Nature. 2011;470(7333):214-220.
140. Cuzick J, Berney DM, Fisher G, et al Transatlantic Prostate Group. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 2012;106(6):1095-1099.
141. Cheng J, Kapranov P, Drenkow J, et al. Transcriptional maps of 10 human chromosomes at 5-nucleotide resolution. Science. 2005;308(5725):1149-1154.
142. Birney E, Stamatoyannopoulos JA, Dutta A, et al ENCODE Project Consortium. Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project. Nature . 2007;447(7146):799-816.
143. Carninci P, Kasukawa T, Katayama S, et al FANTOM Consortium; RIKEN Genome Exploration Research Group and Genome Science Group (Genome Network Project Core Group). The transcriptional landscape of the mammalian genome [published correction appears in Science. 2006; 311(5768):1713]. Science. 2005;309(5740):1559-1563.
144. Oudejans CB, Go AT, Visser A, et al. Detection of chromosome 21-encoded mRNA of placental origin in maternal plasma. Clin Chem. 2003;49(9): 1445-1449.
145. Bussemakers MJ, van Bokhoven A, Verhaegh GW, et al. DD3: a new prostate-specific gene, highly overexpressed in prostate cancer. Cancer Res. 1999;59(23):5975-5979.
146. de Kok JB, Verhaegh GW, Roelofs RW, et al. DD3(PCA3), a very sensitive and specific marker to detect prostate tumors. Cancer Res. 2002;62(9):2695- 2698.
147. Hessels D, Klein Gunnewiek JM, van Oort I, et al. DD3(PCA3)-based molecular urine analysis for the diagnosis of prostate cancer. Eur Urol. 2003; 44(1):8-15; discussion 15-16.
148. Hessels D, van Gils MP, van Hooij O, et al. Predictive value of PCA3 in urinary sediments in determining clinico-pathological characteristics of prostate cancer. Prostate. 2010;70(1):10-16.
149. Laxman B, Morris DS, Yu J, et al. A first-generation multiplex biomarker analysis of urine for the early detection of prostate cancer. Cancer Res. 2008; 68(3):645-649.
150. Sokoll LJ, Ellis W, Lange P, et al. A multicenter evaluation of the PCA3 molecular urine test: pre-analytical effects, analytical performance, and diagnostic accuracy. Clin Chim Acta. 2008;389(1-2):1-6.
151. Keller A, Leidinger P, Bauer A, et al. Toward the blood-borne miRNome of human diseases. Nat Methods. 2011;8(10):841-843.
152. Lin DW, Newcomb LF, Brown EC, et al Canary Prostate Active Surveillance Study Investigators. Urinary TMPRSS2:ERG and PCA3 in an active surveillance cohort: results from a baseline analysis in the Canary Prostate Active Surveillance Study [published online ahead of print May 1, 2013]. Clin Cancer Res. 2013;19(9):2442-2450.
153. Tomlins SA, Aubin SM, Siddiqui J, et al. Urine TMPRSS2:ERG fusion transcript stratifies prostate cancer risk in men with elevated serum PSA. Sci Transl Med. 2011;3(94):94ra72. doi: 10.1126/scitranslmed.3001970.
154. Tomlins SA, Rhodes DR, Perner S, et al. Recurrent fusion of TMPRSS2 and ETS transcription factor genes in prostate cancer. Science. 2005;310(5748):644-648.
155. Barbieri CE, Baca SC, Lawrence MS, et al. Exome sequencing identifies recurrent SPOP, FOXA1 and MED12 mutations in prostate cancer. Nat Genet. 2012;44(6):685-689.
156. Nagai Y, Kojima T, Muro Y, et al. Identification of a novel nuclear speckletype protein, SPOP. FEBS Lett. 1997;418(1-2):23-26.
157. Zhuang M, Calabrese MF, Liu J, et al. Structures of SPOP-substrate complexes: insights into molecular architectures of BTB-Cul3 ubiquitin ligases. Mol Cell. 2009;36(1):39-50.
158. Kan Z, Jaiswal BS, Stinson J, et al. Diverse somatic mutation patterns and pathway alterations in human cancers. Nature. 2010;466(7308):869-873.
159. Kaiser J. Clinical medicine: biomarker tests need closer scrutiny, IOM concludes. Science. 2012;335(6076):1554.
160. Deutsch EW, Ball CA, Berman JJ, et al. Minimum information specification for in situ hybridization and immunohistochemistry experiments (MISFISHIE). Nat Biotechnol. 2008;26(3):305-312.
161. Henry NL, Hayes DF. Cancer biomarkers. Mol Oncol. 2012;6(2):140-146.
162. Wei JT. Limitations of a contemporary prostate biopsy: the blind march forward. Urol Oncol. 2010;28(5):546-549.
163. Liss MA, Santos R, Osann K, Lau A, Ahlering TE, Ornstein DK. PCA3 molecular urine assay for prostate cancer: association with pathologic features and impact of collection protocols. World J Urol. 2011;29(5):683-688.
164. Leyten GH, Hessels D, Jannink SA, et al. Prospective multicentre evaluation of PCA3 and TMPRSS2-ERG gene fusions as diagnostic and prognostic urinary biomarkers for prostate cancer. Eur Urol. 2012.
165. van Gils MP, Hessels D, Hulsbergen-van de Kaa CA, et al. Detailed analysis of histopathological parameters in radical prostatectomy specimens and PCA3 urine test results. Prostate. 2008;68(11):1215-1222.
166. Andriole GL, Crawford ED, Grubb RL III, et al PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360(13):1310-1319.
167. Raaijmakers R, Kirkels WJ, Roobol MJ, Wildhagen MF, Schrder FH. Complication rates and risk factors of 5802 transrectal ultrasound-guided sextant biopsies of the prostate within a population-based screening program. Urology. 2002;60(5):826-830.
168. Sala E, Akin O, Moskowitz CS, et al. Endorectal MR imaging in the evaluation of seminal vesicle invasion: diagnostic accuracy and multivariate feature analysis. Radiology. 2006;238(3):929-937.
169. Wang L, Hricak H, Kattan MW, Chen HN, Scardino PT, Kuroiwa K. Prediction of organ-confined prostate cancer: incremental value of MR imaging and MR spectroscopic imaging to staging nomograms. Radiology. 2006;238(2): 597-603.
170. Vargas HA, Akin O, Afaq A, et al. Magnetic resonance imaging for predicting prostate biopsy findings in patients considered for active surveillance of clinically low risk prostate cancer. J Urol. 2012;188(5):1732-1738.
171. Somford DM, Hoeks CM, Hulsbergen-van de Kaa CA, et al MR-PRIAS Collaboration Group. Evaluation of diffusion-weighted MR imaging at inclusion in an active surveillance protocol for low-risk prostate cancer. Invest Radiol. 2013;48(3):152-157.
172. Selvadurai ED, Singhera M, Thomas K, et al. Medium-term outcomes of active surveillance for localised prostate cancer. Eur Urol. 2013;64(6):981-987.
173. Adamy A, Yee DS, Matsushita K, et al. Role of prostate specific antigen and immediate confirmatory biopsy in predicting progression during active surveillance for low risk prostate cancer. J Urol. 2011;185(2):477-482.
174. Bul M, Zhu X, Valdagni R, et al. Active surveillance for low-risk prostate cancer worldwide: the PRIAS study. Eur Urol. 2013;63(4):597-603.
175. Patel HD, Feng Z, Landis P, Trock BJ, Epstein JI, Carter HB. Prostate specific antigen velocity risk count predicts biopsy reclassification for men with very low risk prostate cancer. J Urol. 2014;191(3):629-637.
176. Newcomb LF, Brooks JD, Carroll PR, et al. Canary prostate active surveillance study: design of a multi-institutional active surveillance cohort and biorepository. Urology. 2010;75(2):407-413.
177. Tosoian JJ, Trock BJ, Landis P, et al. Active surveillance program for prostate cancer: an update of the Johns Hopkins experience. J Clin Oncol. 2011; 29(16):2185-2190.