Definition of Outcome-Based Prostate-Specific Antigen (PSA) Thresholds for Advanced Prostate Cancer Risk Prediction.
Definition of Outcome-Based Prostate-Specific Antigen (PSA) Thresholds for Advanced Prostate Cancer Risk Prediction.
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DOI：
10.3390/cancers13143381
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发表时间：
2021-07-06
期刊：
影响因子：
5.2
通讯作者：
Panteghini M
中科院分区：
文献类型：
--
作者：
Ferraro S;Bussetti M;Bassani N;Rossi RS;Incarbone GP;Bianchi F;Maggioni M;Runza L;Ceriotti F;Panteghini M
在这项研究中，我们使用一个校准良好的风险预测模型来定义前列腺特异性抗原(PSA)阈值，以识别或排除晚期前列腺癌(PCA)，以帮助个性化诊断检查。PSA浓度≤4.1(65岁)和≤3.7μg/L(≥65岁)排除了无腺炎性疾病的晚期PCa，而PSA5.7(65岁)和>；6.1μg/L(≥65岁)建议转介活检。在存在腺体炎症的情况下，PSA不能提供晚期癌症风险的有效估计，因为标记物的变异性更高，而在这一组中，PCa的预试概率很低。建议的PSA阈值可能允许个性化的诊断检查方法，帮助患者做出明智的决定。然而，无症状前列腺炎患者不能从该模型的使用中受益，因为他们不能在活检前被识别。我们从一个校准良好的风险预测模型中定义了前列腺特异性抗原(PSA)阈值，用于识别和排除晚期前列腺癌(PCa)。我们用活检前PSA测定(罗氏试验)检索了902例活检患者。通过校正图法和Hosmer-Lemesow拟合优度检验，建立了包括主要影响因素[即PSA、年龄、腺体炎症的组织学证据(GI)]的Pca预测的Logistic回归模型。PSA阈值是通过假设总体和进展期/低分化性PCa的诊断灵敏度分别为95%(排除)和80%(排除)得出的。在无胃肠道感染的患者中，血清PSA4.1(65岁)和≤3.7μg/L(≥65岁)排除了进展期前列腺癌(定义为活检时的格里森评分≥7)，其阴性预测值分别为95.1%[95%可信区间：83.0~98.7]和88.8%(CI：80.2~93.9)，而PSA5.7(65岁)和6.1μg/L(≥65)应考虑活检转诊。在GI存在的情况下，PSA不能提供晚期癌症风险的有效估计，因为它具有较高的变异性和较低的Pca预测概率。建议的PSA阈值可支持活检决策，但不能在活检前识别的无症状前列腺炎患者除外。
In this study, we used a well calibrated risk prediction model to define prostate-specific antigen (PSA) thresholds for identifying or excluding advanced prostate cancer (PCa) as an aid to personalize management of the diagnostic workup. PSA concentrations ≤ 4.1 (<65 years old) and ≤3.7 μg/L (≥65 years old) excluded an advanced PCa in patients without glandular inflammation, while PSA > 5.7 (<65) and >6.1 μg/L (≥65) suggested a biopsy referral. In the presence of glandular inflammation, PSA does not provide a valid estimate for risk of advanced cancer since the marker variability is higher and the pre-test probability of PCa is low in this group. The proposed PSA thresholds may allow an individualized approach to the diagnostic workup, assisting patients in making an informed decision. However, patients with asymptomatic prostatitis cannot benefit from the use of this model since they cannot be pre-biopsy identified. We defined prostate-specific antigen (PSA) thresholds from a well calibrated risk prediction model for identifying and excluding advanced prostate cancer (PCa). We retrieved 902 biopsied patients with a pre-biopsy PSA determination (Roche assay). A logistic regression model predictive for PCa including the main effects [i.e., PSA, age, histological evidence of glandular inflammation (GI)] was built after testing the accuracy by calibration plots and Hosmer-Lemeshow test for goodness of fit. PSA thresholds were derived by assuming a diagnostic sensitivity of 95% (rule-out) and 80% (rule-in) for overall and advanced/poorly differentiated PCa. In patients without GI, serum PSA concentrations ≤ 4.1 (<65 years old) and ≤3.7 μg/L (≥65 years old) excluded an advanced PCa (defined as Gleason score ≥ 7 at biopsy), with a negative predictive value of 95.1% [95% confidence interval (CI): 83.0–98.7] and 88.8% (CI: 80.2–93.9), respectively, while PSA > 5.7 (<65) and >6.1 μg/L (≥65) should address biopsy referral. In presence of GI, PSA did not provide a valid estimate for risk of advanced cancer because of its higher variability and the low pre-test probability of PCa. The proposed PSA thresholds may support biopsy decision except for patients with asymptomatic prostatitis who cannot be pre-biopsy identified.
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