Construction and Validation of a Clinical Predictive Nomogram for Improving the Cancer Detection of Prostate Naive Biopsy Based on Chinese Multicenter Clinical Data

Tao Tao, Changming Wang, Weiyong Liu, Lei Yuan, Qingyu Ge, Lang Zhang, Biming He, Lei Wang, Ling Wang, Caiping Xiang, Haifeng Wang, Shuqiu Chen, Jun Xiao, Tao Tao, Changming Wang, Weiyong Liu, Lei Yuan, Qingyu Ge, Lang Zhang, Biming He, Lei Wang, Ling Wang, Caiping Xiang, Haifeng Wang, Shuqiu Chen, Jun Xiao

Abstract

Objectives: Prostate biopsy is a common approach for the diagnosis of prostate cancer (PCa) in patients with suspicious PCa. In order to increase the detection rate of prostate naive biopsy, we constructed two effective nomograms for predicting the diagnosis of PCa and clinically significant PCa (csPCa) prior to biopsy.

Materials and methods: The data of 1,428 patients who underwent prostate biopsy in three Chinese medical centers from January 2018 to June 2021 were used to conduct this retrospective study. The KD cohort, which consisted of 701 patients, was used for model construction and internal validation; the DF cohort, which consisted of 385 patients, and the ZD cohort, which consisted of 342 patients, were used for external validation. Independent predictors were selected by univariate and multivariate binary logistic regression analysis and adopted for establishing the predictive nomogram. The apparent performance of the model was evaluated via internal validation and geographically external validation. For assessing the clinical utility of our model, decision curve analysis was also performed.

Results: The results of univariate and multivariate logistic regression analysis showed prostate-specific antigen density (PSAD) (P<0.001, OR:2.102, 95%CI:1.687-2.620) and prostate imaging-reporting and data system (PI-RADS) grade (P<0.001, OR:4.528, 95%CI:2.752-7.453) were independent predictors of PCa before biopsy. Therefore, a nomogram composed of PSAD and PI-RADS grade was constructed. Internal validation in the developed cohort showed that the nomogram had good discrimination (AUC=0.804), and the calibration curve indicated that the predicted incidence was consistent with the observed incidence of PCa; the brier score was 0.172. External validation was performed in the DF and ZD cohorts. The AUC values were 0.884 and 0.882, in the DF and ZD cohorts, respectively. Calibration curves elucidated greatly predicted the accuracy of PCa in the two validation cohorts; the brier scores were 0.129 in the DF cohort and 0.131 in the ZD cohort. Decision curve analysis showed that our model can add net benefits for patients. A separated predicted model for csPCa was also established and validated. The apparent performance of our nomogram for PCa was also assessed in three different PSA groups, and the results were as good as we expected.

Conclusions: In this study, we put forward two simple and convenient clinical predictive models comprised of PSAD and PI-RADS grade with excellent reproducibility and generalizability. They provide a novel calculator for the prediction of the diagnosis of an individual patient with suspicious PCa.

Keywords: PI-RADS score; PSAD; mpMRI; nomogram; prostate biopsy; prostate cancer.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Tao, Wang, Liu, Yuan, Ge, Zhang, He, Wang, Wang, Xiang, Wang, Chen and Xiao.

Figures

Figure 1
Figure 1
Diagnostic nomogram for predicting the outcome of prostate biopsy. It was established by the development cohort. A total point was calculated by combining PSAD and PI-RADS grade, which parallels to a risk value of PCa.
Figure 2
Figure 2
Internal validation of nomogram (PCa) in the KD cohort by bootstrap method (500 resamples). (A) Discrimination of the nomogram was evaluated by the ROC curve; AUC=0.804 which is equal to a c-statistic. (B) Calibration curves illuminate the agreement between the predicted risks of PCa and the observed incidence of PCa. The blue dotted line represents an ideal flawless model.
Figure 3
Figure 3
External validation of the nomogram (PCa) in the DF cohort and the ZD cohort. (A, B) Discrimination of the nomogram was evaluated by the ROC curve; AUC was 0.884 in the DF cohort and 0.882 in the ZD cohort. Calibration curves of the DF cohort (C) and the ZD cohort (D) illuminate the great agreement between the predicted risks of PCa and the observed incidence of PCa. The blue dotted line represents an ideal flawless model.
Figure 4
Figure 4
Decision curve analysis was exhibited to estimate the clinical usefulness of the nomogram (PCa). The quantified net benefits can be measured at different threshold probabilities. The y-axis denotes the standardized net benefit, and the x-axis denotes the threshold probabilities. The red line represents our nomogram, the gray line represents the condition that all patients have PCa, and the black line represents the condition that none have PCa.

References

    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin (2021) 71(1):7–33. doi: 10.3322/caac.21654
    1. Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, et al. . Cancer Statistics in China, 2015. CA Cancer J Clin (2016) 66(2):115–32. doi: 10.3322/caac.21338
    1. Hübner N, Shariat S, Remzi M. Prostate Biopsy: Guidelines and Evidence. Curr Opin Urol (2018) 28(4):354–9. doi: 10.1097/mou.0000000000000510
    1. Xue J, Qin Z, Cai H, Zhang C, Li X, Xu W, et al. . Comparison Between Transrectal and Transperineal Prostate Biopsy for Detection of Prostate Cancer: A Meta-Analysis and Trial Sequential Analysis. Oncotarget (2017) 8(14):23322–36. doi: 10.18632/oncotarget.15056
    1. Park BK. Image-Guided Prostate Biopsy: Necessity for Terminology Standardization. J Ultrasound Med (2020) 39(1):191–6. doi: 10.1002/jum.15083
    1. Moul JW. Comparison of DRE and PSA in the Detection of Prostate Cancer. J Urol (2017) 197(2s):S208–9. doi: 10.1016/j.juro.2016.11.031
    1. Naji L, Randhawa H, Sohani Z, Dennis B, Lautenbach D, Kavanagh O, et al. . Digital Rectal Examination for Prostate Cancer Screening in Primary Care: A Systematic Review and Meta-Analysis. Ann Fam Med (2018) 16(2):149–54. doi: 10.1370/afm.2205
    1. Wang MC, Valenzuela LA, Murphy GP, Chu TM. Purification of a Human Prostate Specific Antigen. J Urol (2017) 197(2s):S148–52. doi: 10.1016/j.juro.2016.10.100
    1. Catalona WJ, Richie JP, Ahmann FR, Hudson MA, Scardino PT, Flanigan RC, et al. . Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer: Results of a Multicenter Clinical Trial of 6,630 Men. J Urol (2017) 197(2s):S200–7. doi: 10.1016/j.juro.2016.10.073
    1. Omri N, Kamil M, Alexander K, Alexander K, Edmond S, Ariel Z, et al. . Association Between PSA Density and Pathologically Significant Prostate Cancer: The Impact of Prostate Volume. Prostate (2020) 80(16):1444–9. doi: 10.1002/pros.24078
    1. Bruno SM, Falagario UG, d’Altilia N, Recchia M, Mancini V, Selvaggio O, et al. . PSA Density Help to Identify Patients With Elevated PSA Due to Prostate Cancer Rather Than Intraprostatic Inflammation: A Prospective Single Center Study. Front Oncol (2021) 11:693684. doi: 10.3389/fonc.2021.693684
    1. Sanguedolce F, Falagario UG, Castellan P, Di Nauta M, Silecchia G, Bruno SM, et al. . Bioptic Intraprostatic Chronic Inflammation Predicts Adverse Pathology at Radical Prostatectomy in Patients With Low-Grade Prostate Cancer. Urol Oncol (2020) 38(10):793.e19–.e25. doi: 10.1016/j.urolonc.2020.02.025
    1. Lamy PJ, Allory Y, Gauchez AS, Asselain B, Beuzeboc P, de Cremoux P, et al. . Prognostic Biomarkers Used for Localised Prostate Cancer Management: A Systematic Review. Eur Urol Focus (2018) 4(6):790–803. doi: 10.1016/j.euf.2017.02.017
    1. Yang Z, Yu L, Wang Z. PCA3 and TMPRSS2-ERG Gene Fusions as Diagnostic Biomarkers for Prostate Cancer. Chin J Cancer Res (2016) 28(1):65–71. doi: 10.3978/j.issn.1000-9604.2016.01.05
    1. Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, et al. . EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment With Curative Intent. Eur Urol (2021) 79(2):243–62. doi: 10.1016/j.eururo.2020.09.042
    1. Carroll PH, Mohler JL. NCCN Guidelines Updates: Prostate Cancer and Prostate Cancer Early Detection. J Natl Compr Canc Netw (2018) 16(5S):620–3. doi: 10.6004/jnccn.2018.0036
    1. Karademir I, Shen DG, Peng YH, Liao S, Jiang YL, Yousuf A, et al. . Prostate Volumes Derived From MRI and Volume-Adjusted Serum Prostate-Specific Antigen: Correlation With Gleason Score of Prostate Cancer. Am J Roentgenol (2013) 201(5):1041–8. doi: 10.2214/Ajr.13.10591
    1. Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, et al. . Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol (2019) 76(3):340–51. doi: 10.1016/j.eururo.2019.02.033
    1. Fang D, Zhao C, Ren D, Yu W, Wang R, Wang H, et al. . Could Magnetic Resonance Imaging Help to Identify the Presence of Prostate Cancer Before Initial Biopsy? The Development of Nomogram Predicting the Outcomes of Prostate Biopsy in the Chinese Population. Ann Surg Oncol (2016) 23(13):4284–92. doi: 10.1245/s10434-016-5438-2
    1. Pabinger I, van Es N, Heinze G, Posch F, Riedl J, Reitter EM, et al. . A Clinical Prediction Model for Cancer-Associated Venous Thromboembolism: A Development and Validation Study in Two Independent Prospective Cohorts. Lancet Haematol (2018) 5(7):e289–98. doi: 10.1016/s2352-3026(18)30063-2
    1. Steyerberg EW, Vergouwe Y. Towards Better Clinical Prediction Models: Seven Steps for Development and an ABCD for Validation. Eur Heart J (2014) 35(29):1925–31. doi: 10.1093/eurheartj/ehu207
    1. Steyerberg EW, Vickers AJ, Cook NR, Gerds T, Gonen M, Obuchowski N, et al. . Assessing the Performance of Prediction Models: A Framework for Traditional and Novel Measures. Epidemiology (2010) 21(1):128–38. doi: 10.1097/EDE.0b013e3181c30fb2
    1. Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, et al. . Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol (2016) 34(18):2157–64. doi: 10.1200/jco.2015.65.9128
    1. Drost FH, Osses D, Nieboer D, Bangma CH, Steyerberg EW, Roobol MJ, et al. . Prostate Magnetic Resonance Imaging, With or Without Magnetic Resonance Imaging-Targeted Biopsy, and Systematic Biopsy for Detecting Prostate Cancer: A Cochrane Systematic Review and Meta-Analysis. Eur Urol (2020) 77(1):78–94. doi: 10.1016/j.eururo.2019.06.023
    1. Miah S, Hosking-Jervis F, Connor MJ, Eldred-Evans D, Shah TT, Arya M, et al. . A Multicentre Analysis of the Detection of Clinically Significant Prostate Cancer Following Transperineal Image-Fusion Targeted and Nontargeted Systematic Prostate Biopsy in Men at Risk. Eur Urol Oncol (2020) 3(3):262–9. doi: 10.1016/j.euo.2019.03.005
    1. Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, et al. . Diagnostic Accuracy of Multi-Parametric MRI and TRUS Biopsy in Prostate Cancer (PROMIS): A Paired Validating Confirmatory Study. Lancet (2017) 389(10071):815–22. doi: 10.1016/s0140-6736(16)32401-1
    1. Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, et al. . MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med (2018) 378(19):1767–77. doi: 10.1056/NEJMoa1801993
    1. Rouvière O, Puech P, Renard-Penna R, Claudon M, Roy C, Mège-Lechevallier F, et al. . Use of Prostate Systematic and Targeted Biopsy on the Basis of Multiparametric MRI in Biopsy-Naive Patients (MRI-FIRST): A Prospective, Multicentre, Paired Diagnostic Study. Lancet Oncol (2019) 20(1):100–9. doi: 10.1016/s1470-2045(18)30569-2
    1. Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, et al. . MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med (2020) 382(10):917–28. doi: 10.1056/NEJMoa1910038
    1. Rapisarda S, Bada M, Crocetto F, Barone B, Arcaniolo D, Polara A, et al. . The Role of Multiparametric Resonance and Biopsy in Prostate Cancer Detection: Comparison With Definitive Histological Report After Laparoscopic/Robotic Radical Prostatectomy. Abdom Radiol (NY) (2020) 45(12):4178–84. doi: 10.1007/s00261-020-02798-8
    1. Grossman DC, Curry SJ, Owens DK, Bibbins-Domingo K, Caughey AB, Davidson KW, et al. . Screening for Prostate Cancer: US Preventive Services Task Force Recommendation Statement. Jama (2018) 319(18):1901–13. doi: 10.1001/jama.2018.3710
    1. Rouvière O, Schoots IG, Mottet N. Multiparametric Magnetic Resonance Imaging Before Prostate Biopsy: A Chain Is Only as Strong as Its Weakest Link. Eur Urol (2019) 75(6):889–90. doi: 10.1016/j.eururo.2019.03.023
    1. Rosenkrantz AB, Ginocchio LA, Cornfeld D, Froemming AT, Gupta RT, Turkbey B, et al. . Interobserver Reproducibility of the PI-RADS Version 2 Lexicon: A Multicenter Study of Six Experienced Prostate Radiologists. Radiology (2016) 280(3):793–804. doi: 10.1148/radiol.2016152542
    1. He BM, Chen R, Sun TQ, Yang Y, Zhang CL, Ren SC, et al. . Prostate Cancer Risk Prediction Models in Eastern Asian Populations: Current Status, Racial Difference, and Future Directions. Asian J Androl (2020) 22(2):158–61. doi: 10.4103/aja.aja_55_19
    1. Yoon DK, Park JY, Yoon S, Park MS, Moon du G, Lee JG, et al. . Can the Prostate Risk Calculator Based on Western Population be Applied to Asian Population? Prostate (2012) 72(7):721–9. doi: 10.1002/pros.21475
    1. Chen R, Xie L, Xue W, Ye Z, Ma L, Gao X, et al. . Development and External Multicenter Validation of Chinese Prostate Cancer Consortium Prostate Cancer Risk Calculator for Initial Prostate Biopsy. Urol Oncol (2016) 34(9):416.e1–7. doi: 10.1016/j.urolonc.2016.04.004
    1. Niu XK, He WF, Zhang Y, Das SK, Li J, Xiong Y, et al. . Developing a New PI-RADS V2-Based Nomogram for Forecasting High-Grade Prostate Cancer. Clin Radiol (2017) 72(6):458–64. doi: 10.1016/j.crad.2016.12.005
    1. Li M, Chen T, Zhao W, Wei C, Li X, Duan S, et al. . Radiomics Prediction Model for the Improved Diagnosis of Clinically Significant Prostate Cancer on Biparametric MRI. Quant Imaging Med Surg (2020) 10(2):368–79. doi: 10.21037/qims.2019.12.06
    1. Li X, Pan Y, Huang Y, Wang J, Zhang C, Wu J, et al. . Developing a Model for Forecasting Gleason Score ≥7 in Potential Prostate Cancer Patients to Reduce Unnecessary Prostate Biopsies. Int Urol Nephrol (2016) 48(4):535–40. doi: 10.1007/s11255-016-1218-y
    1. Tao T, Shen D, Yuan L, Zeng A, Xia K, Li B, et al. . Establishing a Novel Prediction Model for Improving the Positive Rate of Prostate Biopsy. Transl Androl Urol (2020) 9(2):574–82. doi: 10.21037/tau.2019.12.42
    1. Liu J, Dong B, Qu W, Wang J, Xu Y, Yu S, et al. . Using Clinical Parameters to Predict Prostate Cancer and Reduce the Unnecessary Biopsy Among Patients With PSA in the Gray Zone. Sci Rep (2020) 10(1):5157. doi: 10.1038/s41598-020-62015-w
    1. Falagario UG, Silecchia G, Bruno SM, Di Nauta M, Auciello M, Sanguedolce F, et al. . Does Multiparametric Magnetic Resonance of Prostate Outperform Risk Calculators in Predicting Prostate Cancer in Biopsy Naïve Patients? Front Oncol (2020) 10:603384. doi: 10.3389/fonc.2020.603384
    1. Alberts AR, Schoots IG, Roobol MJ. Prostate-Specific Antigen-Based Prostate Cancer Screening: Past and Future. Int J Urol (2015) 22(6):524–32. doi: 10.1111/iju.12750
    1. Falagario UG, Jambor I, Lantz A, Ettala O, Stabile A, Taimen P, et al. . Combined Use of Prostate-Specific Antigen Density and Magnetic Resonance Imaging for Prostate Biopsy Decision Planning: A Retrospective Multi-Institutional Study Using the Prostate Magnetic Resonance Imaging Outcome Database (PROMOD). Eur Urol Oncol (2020) 4(6):971–9. doi: 10.1016/j.euo.2020.08.014
    1. Washino S, Okochi T, Saito K, Konishi T, Hirai M, Kobayashi Y, et al. . Combination of Prostate Imaging Reporting and Data System (PI-RADS) Score and Prostate-Specific Antigen (PSA) Density Predicts Biopsy Outcome in Prostate Biopsy Naïve Patients. BJU Int (2017) 119(2):225–33. doi: 10.1111/bju.13465
    1. Falagario UG, Martini A, Wajswol E, Treacy PJ, Ratnani P, Jambor I, et al. . Avoiding Unnecessary Magnetic Resonance Imaging (MRI) and Biopsies: Negative and Positive Predictive Value of MRI According to Prostate-Specific Antigen Density, 4Kscore and Risk Calculators. Eur Urol Oncol (2020) 3(5):700–4. doi: 10.1016/j.euo.2019.08.015
    1. Maggi M, Del Giudice F, Falagario UG, Cocci A, Russo GI, Di Mauro M, et al. . SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study. Cancers (Basel) (2021) 13(9):2047. doi: 10.3390/cancers13092047
    1. Falagario UG, Ratnani P, Lantz A, Jambor I, Dovey Z, Verma A, et al. . Staging Accuracy of Multiparametric Magnetic Resonance Imaging in Caucasian and African American Men Undergoing Radical Prostatectomy. J Urol (2020) 204(1):82–90. doi: 10.1097/ju.0000000000000774

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