Molecular Biomarkers for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis
Tài liệu tham khảo
Sung, 2021, Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, Cancer J Clin, 71, 209, 10.3322/caac.21660
Torre, 2016, Global cancer incidence and mortality rates and trends—an update, Cancer Epidemiol Biomarkers Prev, 25, 16, 10.1158/1055-9965.EPI-15-0578
Bell, 2015, Prevalence of incidental prostate cancer: a systematic review of autopsy studies, Int J Cancer, 137, 1749, 10.1002/ijc.29538
Ferlay, 2020, 419
National Cancer Institute, 2019
Fenton, 2018, Prostate-specific antigen-based screening for prostate cancer: evidence report and a systematic review for the U.S. Preventive Services Task Force, JAMA, 319, 1914, 10.1001/jama.2018.3712
Mottet N, Bellmunt J, Briers E, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG guidelines on prostate cancer. 2021.
Loeb, 2017, Whom to biopsy: prediagnostic risk stratification with biomarkers, nomograms, and risk calculators, Urol Clin North Am, 44, 517, 10.1016/j.ucl.2017.07.001
Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. Cochrane Collaboration; 2011.
Page, 2021, The PRISMA 2020 statement: an updated guideline for reporting systematic reviews, BMJ, 372
Sterne, 2019, RoB 2: a revised tool for assessing risk of bias in randomised trials, Br Med J, 366
Whiting, 2011, QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies, Ann Intern Med, 155, 529, 10.7326/0003-4819-155-8-201110180-00009
Deeks, 2005, The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed, J Clin Epidemiol, 58, 882, 10.1016/j.jclinepi.2005.01.016
Dwamena, 2007, MIDAS: Stata module for meta-analytical integration of diagnostic test accuracy studies, Statistical Software Components
Higgins, 2003, Measuring inconsistency in meta-analyses, Br Med J, 327, 557, 10.1136/bmj.327.7414.557
Schünemann, 2019, GRADE guidelines: 22. The GRADE approach for tests and strategies—from test accuracy to patient-important outcomes and recommendations, J Clin Epidemiol, 111, 69, 10.1016/j.jclinepi.2019.02.003
Parekh, 2015, A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer, Eur Urol, 68, 464, 10.1016/j.eururo.2014.10.021
Bollito, 2012, Prostate cancer gene 3 urine assay cutoff in diagnosis of prostate cancer: a validation study on an Italian patient population undergoing first and repeat biopsy, Anal Quant Cytol Histol, 34, 96
Hennenlotter, 2020, Age-adapted prostate cancer gene 3 score interpretation—suggestions for clinical use, Clin Lab, 66, 10.7754/Clin.Lab.2019.190714
Schulze, 2020, Use of the Prostate Health Index and density in 3 outpatient centers to avoid unnecessary prostate biopsies, Urol Int, 104, 181, 10.1159/000506262
Steuber, 2022, PROPOSe: a real-life prospective study of Proclarix, a novel blood-based test to support challenging biopsy decision-making in prostate cancer, Eur Urol Oncol, 5, 321, 10.1016/j.euo.2020.12.003
Babajide, 2021, Performance of Prostate Health Index in biopsy naïve black men, J Urol, 205, 718, 10.1097/JU.0000000000001453
Cao, 2018, Combination of prostate cancer antigen 3 and prostate-specific antigen improves diagnostic accuracy in men at risk of prostate cancer, Arch Pathol Lab Med, 142, 1106, 10.5858/arpa.2017-0185-OA
Catalona, 2011, A multi-center study of [−2]pro-prostate-specific antigen (PSA) in combination with PSA and free PSA for prostate cancer detection in the 2.0 to 10.0 ng/ml PSA range, J Urol, 185, 1650, 10.1016/j.juro.2010.12.032
De La Calle, 2015, Multicenter evaluation of the prostate health index to detect aggressive prostate cancer in biopsy naïve men, J Urol, 194, 65, 10.1016/j.juro.2015.01.091
Druskin, 2018, Combining Prostate Health Index density, magnetic resonance imaging and prior negative biopsy status to improve the detection of clinically significant prostate cancer, BJU Int, 121, 619, 10.1111/bju.14098
Falagario, 2021, Using biomarkers in patients with positive multiparametric magnetic resonance imaging: 4Kscore predicts the presence of cancer outside the index lesion, Int J Urol, 28, 47, 10.1111/iju.14385
Hansen, 2013, Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay, Eur Urol, 63, 201, 10.1016/j.eururo.2012.07.030
Loeb, 2015, The prostate health index selectively identifies clinically significant prostate cancer, J Urol, 193, 1163, 10.1016/j.juro.2014.10.121
Loeb, 2017, Prostate Health Index improves multivariable risk prediction of aggressive prostate cancer, BJU Int, 120, 61, 10.1111/bju.13676
McKiernan, 2016, A novel urine exosome gene expression assay to predict high-grade prostate cancer at initial biopsy, JAMA Oncol, 2, 882, 10.1001/jamaoncol.2016.0097
Bertok, 2020, Validating fPSA glycoprofile as a prostate cancer biomarker to avoid unnecessary biopsies and re-biopsies, Cancers (Basel), 12, 2988, 10.3390/cancers12102988
O’Malley, 2017, Racial variation in the utility of urinary biomarkers PCA3 and T2ERG in a large multicenter study, J Urol, 198, 42, 10.1016/j.juro.2017.01.058
Punnen, 2018, A multi-institutional prospective trial confirms noninvasive blood test maintains predictive value in African American men, J Urol, 199, 1459, 10.1016/j.juro.2017.11.113
Sanda, 2017, Association between combined TMPRSS2:ERG and PCA3 RNA urinary testing and detection of aggressive prostate cancer, JAMA Oncol, 3, 1085, 10.1001/jamaoncol.2017.0177
Shore, 2019, Urinary molecular biomarker test impacts prostate biopsy decision making in clinical practice, Urol Pract, 6, 256, 10.1016/j.urpr.2018.09.002
Tomlins, 2016, Urine TMPRSS2:ERG plus PCA3 for individualized prostate cancer risk assessment, Eur Urol, 70, 45, 10.1016/j.eururo.2015.04.039
Tosoian, 2017, Prostate Health Index density improves detection of clinically significant prostate cancer, BJU Int, 120, 793, 10.1111/bju.13762
Tosoian, 2017, Longitudinal assessment of urinary PCA3 for predicting prostate cancer grade reclassification in favorable-risk men during active surveillance, Prostate Cancer Prostatic Dis, 20, 339, 10.1038/pcan.2017.16
Tosoian, 2021, Use of the MyProstateScore test to rule out clinically significant cancer: validation of a straightforward clinical testing approach, J Urol, 205, 732, 10.1097/JU.0000000000001430
Wei, 2014, Can urinary PCA3 supplement PSA in the early detection of prostate cancer?, J Clin Oncol, 32, 4066, 10.1200/JCO.2013.52.8505
Wysock, 2020, Concordance and performance of 4Kscore and SelectMDx for informing decision to perform prostate biopsy and detection of prostate cancer, Urology, 141, 119, 10.1016/j.urology.2020.02.032
Chiu, 2016, Extended use of prostate health index and percentage of [-2]pro-prostate-specific antigen in Chinese men with prostate specific antigen 10–20 ng/mL and normal digital rectal examination, Investig Clin Urol, 57, 336, 10.4111/icu.2016.57.5.336
Zappala, 2017, The 4Kscore blood test accurately identifies men with aggressive prostate cancer prior to prostate biopsy with or without DRE information, Int J Clin Pract, 71, e12943, 10.1111/ijcp.12943
Filella, 2014, The influence of prostate volume in prostate health index performance in patients with total PSA lower than 10μg/L, Clin Chim Acta, 436, 303, 10.1016/j.cca.2014.06.019
Foj, 2020, Development and internal validation of a novel PHI-nomogram to identify aggressive prostate cancer, Clin Chim Acta, 501, 174, 10.1016/j.cca.2019.10.039
Morote, 2016, Eficacia del índice de salud prostática para identificar cánceres de próstata agresivos. Una validación institucional, Actas Urol Esp, 40, 378, 10.1016/j.acuro.2016.01.004
Sanchís-Bonet, 2018, Validation of the prostate health index in a predictive model of prostate cancer, Actas Urol Esp, 42, 25, 10.1016/j.acuro.2017.06.003
Roumiguié, 2020, Independent evaluation of the respective predictive values for high-grade prostate cancer of clinical information and RNA biomarkers after upfront MRI and image-guided biopsies, Cancers (Basel), 12, 285, 10.3390/cancers12020285
Ruffion, 2013, PCA3 and PCA3-based nomograms improve diagnostic accuracy in patients undergoing first prostate biopsy, Int J Mol Sci, 14, 17767, 10.3390/ijms140917767
Ruffion, 2014, Additional value of PCA3 density to predict initial prostate biopsy outcome, World J Urol, 32, 917, 10.1007/s00345-014-1251-3
Seisen, 2015, Accuracy of the prostate health index versus the urinary prostate cancer antigen 3 score to predict overall and significant prostate cancer at initial biopsy, Prostate, 75, 103, 10.1002/pros.22898
Leyten, 2015, Identification of a candidate gene panel for the early diagnosis of prostate cancer, Clin Cancer Res, 21, 3061, 10.1158/1078-0432.CCR-14-3334
Chiu, 2016, Prostate Health Index (PHI) and prostate-specific antigen (PSA) predictive models for prostate cancer in the Chinese population and the role of digital rectal examination-estimated prostate volume, Int Urol Nephrol, 48, 1631, 10.1007/s11255-016-1350-8
Van Neste, 2016, Detection of high-grade prostate cancer using a urinary molecular biomarker–based risk score, Eur Urol, 70, 740, 10.1016/j.eururo.2016.04.012
Foley, 2016, European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculators significantly outperform the Prostate Cancer Prevention Trial (PCPT) 2.0 in the prediction of prostate cancer: a multi-institutional study, BJU Int, 118, 706, 10.1111/bju.13437
Busetto, 2020, Prospective assessment of two-gene urinary test with multiparametric magnetic resonance imaging of the prostate for men undergoing primary prostate biopsy, World J Urol, 39, 1869, 10.1007/s00345-020-03359-w
Guazzoni, 2011, Prostate-specific antigen (PSA) isoform p2PSA significantly improves the prediction of prostate cancer at initial extended prostate biopsies in patients with total PSA between 2.0 and 10 ng/ml: results of a prospective study in a clinical setting, Eur Urol, 60, 214, 10.1016/j.eururo.2011.03.052
Mearini, 2014, Evaluation of prostate-specific antigen isoform p2PSA and its derivates, %p2PSA, prostate health index and prostate dimension-adjusted related index in the detection of prostate cancer at first biopsy: an exploratory, prospective study, Urol Int, 93, 135, 10.1159/000356240
Furuya, 2017, Measurement of serum isoform [–2]proPSA derivatives shows superior accuracy to magnetic resonance imaging in the diagnosis of prostate cancer in patients with a total prostate-specific antigen level of 2–10 ng/ml, Scand J Urol, 51, 251, 10.1080/21681805.2017.1298155
Choi, 2020, Correlation between Gleason score distribution and prostate health index in patients with prostate-specific antigen values of 2.5–10 ng/ml, Investig Clin Urol, 61, 582, 10.4111/icu.20200084
Park, 2018, Diagnostic performance of %[-2]proPSA and Prostate Health Index for prostate cancer: prospective, multi-institutional study, J Korean Med Sci, 33, e94, 10.3346/jkms.2018.33.e94
Barisiene, 2020, Prostate Health Index and Prostate Health Index density as diagnostic tools for improved prostate cancer detection, Biomed Res Int, 2020, 9872146, 10.1155/2020/9872146
Kim, 2020, Clinical utility and cost modelling of the phi test to triage referrals into image-based diagnostic services for suspected prostate cancer: the PRIM (Phi to RefIne Mri) study, BMC Med, 18, 95, 10.1186/s12916-020-01548-3
Na, 2017, Prostate Health Index significantly reduced unnecessary prostate biopsies in patients with PSA 2–10 ng/mL and PSA >10 ng/mL: results from a multicenter study in China, Prostate, 77, 1221, 10.1002/pros.23382
Kotova, 2020, Identification of clinically significant prostate cancer by combined PCA3 and AMACR mRNA detection in urine samples, Res Reports Urol, 12, 403, 10.2147/RRU.S262310
Tan, 2017, Prospective validation of %p2PSA and the Prostate Health Index, in prostate cancer detection in initial prostate biopsies of Asian men, with total PSA 4–10 ng ml1, Asian J Androl, 19, 286, 10.4103/1008-682X.168687
Nordström, 2014, 339 A head to head comparison between a 4-kallikrein panel and a [-2]proPSA derivative model, Eur Urol Suppl, 13, e339, 10.1016/S1569-9056(14)60334-1
Nordström, 2021, Identifying prostate cancer among men with lower urinary tract symptoms, Eur Urol Open Sci, 24, 11, 10.1016/j.euros.2020.12.004
Mortezavi, 2021, Head-to-head comparison of conventional, and image- and biomarker-based prostate cancer risk calculators, Eur Urol Focus, 7, 546, 10.1016/j.euf.2020.05.002
Nygård, 2015, Prostate cancer antigen-3 (PCA3) and PCA3-based nomograms in the diagnosis of prostate cancer: an external validation of Hansen’s nomogram on a Norwegian cohort, Scand J Urol, 49, 8, 10.3109/21681805.2014.949841
Hsieh, 2020, Combining prostate health index and multiparametric magnetic resonance imaging in the diagnosis of clinically significant prostate cancer in an Asian population, World J Urol, 38, 1207, 10.1007/s00345-019-02889-2
Fan, 2019, Prostate Health Index outperforms other PSA derivatives in predicting a positive biopsy in men with tPSA <10 ng/mL: Largest prospective cohort in Taiwan, J Chin Med Assoc, 82, 772, 10.1097/JCMA.0000000000000160
Abrate, 2015, Clinical performance of the Prostate Health Index (PHI) for the prediction of prostate cancer in obese men: data from the PROMEtheuS project, a multicentre European prospective study, BJU Int, 115, 537, 10.1111/bju.12907
Boegemann, 2016, The percentage of prostate-specific antigen (PSA) isoform [-2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men, BJU Int, 117, 72, 10.1111/bju.13139
Na, 2014, Performance of serum prostate-specific antigen isoform [-2]proPSA (p2PSA) and the Prostate Health Index (PHI) in a Chinese hospital-based biopsy population, Prostate, 74, 1569, 10.1002/pros.22876
Chiu, 2019, A multicentre evaluation of the role of the Prostate Health Index (PHI) in regions with differing prevalence of prostate cancer: adjustment of PHI reference ranges is needed for European and Asian settings, Eur Urol, 75, 558, 10.1016/j.eururo.2018.10.047
Haese, 2019, Multicenter optimization and validation of a 2-Gene mRNA urine test for detection of clinically significant prostate cancer before initial prostate biopsy, J Urol, 202, 256, 10.1097/JU.0000000000000293
Scattoni, 2013, Head-to-head comparison of prostate health index and urinary PCA3 for predicting cancer at initial or repeat biopsy, J Urol, 190, 496, 10.1016/j.juro.2013.02.3184
Lazzeri, 2016, Clinical performance of prostate health index in men with tPSA>10 ng/ml: results from a multicentric European study, Urol Oncol, 34, 415.e13, 10.1016/j.urolonc.2016.04.003
Woo, 2020, Urine extracellular vesicle GATA2 mRNA discriminates biopsy result in men with suspicion of prostate cancer, J Urol, 204, 691, 10.1097/JU.0000000000001066
Wang, 2017, Prostate cancer antigen 3 moderately improves diagnostic accuracy in Chinese patients undergoing first prostate biopsy, Asian J Androl, 19, 238, 10.4103/1008-682X.167715
Yu, 2016, Performance of the Prostate Health Index in predicting prostate biopsy outcomes among men with a negative digital rectal examination and transrectal ultrasonography, Asian J Androl, 18, 633, 10.4103/1008-682X.172823
Wu, 2019, Establishment of reference intervals for serum [−2]propsa (P2PSA), %P2PSA and Prostate Health Index in healthy men, Onco Targets Ther, 12, 6453, 10.2147/OTT.S212340
Grönberg, 2018, Prostate cancer diagnostics using a combination of the Stockholm3 blood test and multiparametric magnetic resonance imaging, Eur Urol, 74, 722, 10.1016/j.eururo.2018.06.022
Hendriks, 2017, A urinary biomarker-based risk score correlates with multiparametric MRI for prostate cancer detection, Prostate, 77, 1401, 10.1002/pros.23401
Foley, 2016, Improving multivariable prostate cancer risk assessment using the Prostate Health Index, BJU Int, 117, 409, 10.1111/bju.13143
Huang, 2020, Cost-effectiveness analysis of Prostate Health Index in decision making for initial prostate biopsy, Front Oncol, 10, 10.3389/fonc.2020.565382
Wu, 2019, PHI-based risk calculators performed better in the prediction of prostate cancer in the Chinese population, Asian J Androl, 21, 592, 10.4103/aja.aja_125_18
Barisiene, 2021, Prostate Health Index and Prostate Health Index density as diagnostic tools for improved prostate cancer detection, BJU Int, 2020, 718
Filella, 2014, Clinical utility of %p2PSA and prostate health index in the detection of prostate cancer, Clin Chem Lab Med, 52, 1347, 10.1515/cclm-2014-0027
Lazzeri, 2013, Serum isoform [-2]proPSA derivatives significantly improve prediction of prostate cancer at initial biopsy in a total PSA range of 2–10 ng/ml: a multicentric European study, Eur Urol, 63, 986, 10.1016/j.eururo.2013.01.011
Nordström, 2015, Comparison between the four-kallikrein panel and prostate health index for predicting prostate cancer, Eur Urol, 68, 139, 10.1016/j.eururo.2014.08.010
Tosoian, 2017, Use of the Prostate Health Index for detection of prostate cancer: results from a large academic practice, Prostate Cancer Prostatic Dis, 20, 228, 10.1038/pcan.2016.72
Nygård, 2016, A positive real-time elastography (RTE) combined with a Prostate Cancer Gene 3 (PCA3) score above 35 convey a high probability of intermediate- or high-risk prostate cancer in patient admitted for primary prostate biopsy, BMC Urol, 16, 1, 10.1186/s12894-016-0159-1
Russo, 2017, A systematic review and meta-analysis of the diagnostic accuracy of Prostate Health Index and 4-Kallikrein Panel score in predicting overall and high-grade prostate cancer, Clin Genitourin Cancer, 15, 429, 10.1016/j.clgc.2016.12.022
Muñoz Rodríguez, 2020, Diagnostic accuracy of prostate cancer antigen 3 (PCA3) prior to first prostate biopsy: a systematic review and meta-analysis, Can Urol Assoc J, 14, 1
Lee, 2020, Diagnostic performance of the prostate cancer antigen 3 test in prostate cancer: systematic review and meta-analysis, Clin Genitourin Cancer, 18, 402, 10.1016/j.clgc.2020.03.005
García-Perdomo, 2018, Association between TMPRSS2:ERG fusion gene and the prostate cancer: systematic review and meta-analysis, Cent Eur J Urol, 71, 410
Filella, 2013, Evaluation of [-2] proPSA and prostate health index (phi) for the detection of prostate cancer: a systematic review and meta-analysis, Clin Chem Lab Med, 51, 729, 10.1515/cclm-2012-0410
Zappala, 2017, Clinical performance of the 4Kscore test to predict high-grade prostate cancer at biopsy: a meta-analysis of us and European clinical validation study results, Rev Urol, 19, 149
Acosta, 2017, Biomarcadores de pronóstico en pacientes con cáncer de próstata localizado, Rev Colomb Cancerol, 21, 113, 10.1016/j.rccan.2016.07.004
Olleik, 2018, Evaluation of new tests and interventions for prostate cancer management: a systematic review, JNCCN J Natl Compr Cancer Netw, 16, 1340, 10.6004/jnccn.2018.7055