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前列腺健康指数(PHI)在预测肥胖男性前列腺癌方面的临床性能:来自欧洲多中心前瞻性研究PROMEtheuS项目的数据。

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.

作者信息

Abrate Alberto, Lazzeri Massimo, Lughezzani Giovanni, Buffi Nicolòmaria, Bini Vittorio, Haese Alexander, de la Taille Alexandre, McNicholas Thomas, Redorta Joan Palou, Gadda Giulio M, Lista Giuliana, Kinzikeeva Ella, Fossati Nicola, Larcher Alessandro, Dell'Oglio Paolo, Mistretta Francesco, Freschi Massimo, Guazzoni Giorgio

机构信息

Division of Oncology, Unit of Urology, URI, Milan, Italy.

出版信息

BJU Int. 2015 Apr;115(4):537-45. doi: 10.1111/bju.12907.

DOI:10.1111/bju.12907
PMID:25130593
Abstract

OBJECTIVES

To test serum prostate-specific antigen (PSA) isoform [-2]proPSA (p2PSA), p2PSA/free PSA (%p2PSA) and Prostate Health Index (PHI) accuracy in predicting prostate cancer in obese men and to test whether PHI is more accurate than PSA in predicting prostate cancer in obese patients.

PATIENTS AND METHODS

The analysis consisted of a nested case-control study from the pro-PSA Multicentric European Study (PROMEtheuS) project. The study is registered at http://www.controlled-trials.com/ISRCTN04707454. The primary outcome was to test sensitivity, specificity and accuracy (clinical validity) of serum p2PSA, %p2PSA and PHI, in determining prostate cancer at prostate biopsy in obese men [body mass index (BMI) ≥30 kg/m(2) ], compared with total PSA (tPSA), free PSA (fPSA) and fPSA/tPSA ratio (%fPSA). The number of avoidable prostate biopsies (clinical utility) was also assessed. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision-curve analysis.

RESULTS

Of the 965 patients, 383 (39.7%) were normal weight (BMI <25 kg/m(2) ), 440 (45.6%) were overweight (BMI 25-29.9 kg/m(2) ) and 142 (14.7%) were obese (BMI ≥30 kg/m(2) ). Among obese patients, prostate cancer was found in 65 patients (45.8%), with a higher percentage of Gleason score ≥7 diseases (67.7%). PSA, p2PSA, %p2PSA and PHI were significantly higher, and %fPSA significantly lower in patients with prostate cancer (P < 0.001). In multivariable logistic regression models, PHI significantly increased accuracy of the base multivariable model by 8.8% (P = 0.007). At a PHI threshold of 35.7, 46 (32.4%) biopsies could have been avoided.

CONCLUSION

In obese patients, PHI is significantly more accurate than current tests in predicting prostate cancer.

摘要

目的

检测血清前列腺特异性抗原(PSA)异构体[-2]前体PSA(p2PSA)、p2PSA/游离PSA(%p2PSA)和前列腺健康指数(PHI)在预测肥胖男性前列腺癌方面的准确性,并检测在预测肥胖患者前列腺癌方面PHI是否比PSA更准确。

患者与方法

分析包括来自前体PSA多中心欧洲研究(PROMEtheuS)项目的一项巢式病例对照研究。该研究已在http://www.controlled-trials.com/ISRCTN04707454注册。主要结局是检测血清p2PSA、%p2PSA和PHI在确定肥胖男性[体重指数(BMI)≥30 kg/m²]前列腺活检时前列腺癌方面的敏感性、特异性和准确性(临床有效性),并与总PSA(tPSA)、游离PSA(fPSA)和fPSA/tPSA比值(%fPSA)进行比较。还评估了可避免的前列腺活检数量(临床实用性)。多变量逻辑回归模型辅以预测准确性分析和决策曲线分析。

结果

965例患者中,383例(39.7%)体重正常(BMI<25 kg/m²),440例(45.6%)超重(BMI 25 - 29.9 kg/m²),142例(14.7%)肥胖(BMI≥30 kg/m²)。在肥胖患者中,65例(45.8%)发现前列腺癌,Gleason评分≥7分疾病的比例更高(67.7%)。前列腺癌患者的PSA、p2PSA、%p2PSA和PHI显著更高,而%fPSA显著更低(P<0.001)。在多变量逻辑回归模型中,PHI使基础多变量模型的准确性显著提高了8.8%(P = 0.007)。在PHI阈值为35.7时,46例(32.4%)活检本可避免。

结论

在肥胖患者中,PHI在预测前列腺癌方面比目前的检测方法显著更准确。

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