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
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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. / Lazzeri, Massimo; Haese, Alexander; de la Taille, Alexandre; Palou Redorta, Joan; McNicholas, Thomas; Lughezzani, Giovanni; Scattoni, Vincenzo; Bini, Vittorio; Freschi, Massimo; Sussman, Amy; Ghaleh, Bijan; Le Corvoisier, Philippe; Alberola Bou, Josep; Esquena Fernández, Salvador; Graefen, Markus; Guazzoni, Giorgio.
In: EUR UROL, Vol. 63, No. 6, 01.06.2013, p. 986-94.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - 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
AU - Lazzeri, Massimo
AU - Haese, Alexander
AU - de la Taille, Alexandre
AU - Palou Redorta, Joan
AU - McNicholas, Thomas
AU - Lughezzani, Giovanni
AU - Scattoni, Vincenzo
AU - Bini, Vittorio
AU - Freschi, Massimo
AU - Sussman, Amy
AU - Ghaleh, Bijan
AU - Le Corvoisier, Philippe
AU - Alberola Bou, Josep
AU - Esquena Fernández, Salvador
AU - Graefen, Markus
AU - Guazzoni, Giorgio
N1 - Copyright © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.
PY - 2013/6/1
Y1 - 2013/6/1
N2 - BACKGROUND: Strategies to reduce prostate-specific antigen (PSA)-driven prostate cancer (PCa) overdiagnosis and overtreatment seem to be necessary.OBJECTIVE: To test the accuracy of serum isoform [-2]proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (fPSA; %p2PSA) and the Prostate Health Index (PHI)-called index tests-in discriminating between patients with and without PCa.DESIGN, SETTING, AND PARTICIPANTS: This was an observational, prospective cohort study of patients from five European urologic centers with a total PSA (tPSA) range of 2-10 ng/ml who were subjected to initial prostate biopsy for suspected PCa.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was to evaluate the specificity, sensitivity, and diagnostic accuracy of index tests in determining the presence of PCa at prostate biopsy in comparison to tPSA, fPSA, and percentage of fPSA to tPSA (%fPSA) (standard tests) and the number of prostate biopsies that could be spared using these tests. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis.RESULTS AND LIMITATIONS: Of >646 patients, PCa was diagnosed in 264 (40.1%). Median tPSA (5.7 vs 5.8 ng/ml; p=0.942) and p2PSA (15.0 vs 14.7 pg/ml) did not differ between groups; conversely, median fPSA (0.7 vs 1 ng/ml; p<0.001), %fPSA (0.14 vs 0.17; p<0.001), %p2PSA (2.1 vs 1.6; p<0.001), and PHI (48.2 vs 38; p<0.001) did differ significantly between men with and without PCa. In multivariable logistic regression models, p2PSA, %p2PSA, and PHI significantly increased the accuracy of the base multivariable model by 6.4%, 5.6%, and 6.4%, respectively (all p<0.001). At a PHI cut-off of 27.6, a total of 100 (15.5%) biopsies could have been avoided. The main limitation is that cases were selected on the basis of their initial tPSA values.CONCLUSIONS: In patients with a tPSA range of 2-10 ng/ml, %p2PSA and PHI are the strongest predictors of PCa at initial biopsy and are significantly more accurate than tPSA and %fPSA.
AB - BACKGROUND: Strategies to reduce prostate-specific antigen (PSA)-driven prostate cancer (PCa) overdiagnosis and overtreatment seem to be necessary.OBJECTIVE: To test the accuracy of serum isoform [-2]proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (fPSA; %p2PSA) and the Prostate Health Index (PHI)-called index tests-in discriminating between patients with and without PCa.DESIGN, SETTING, AND PARTICIPANTS: This was an observational, prospective cohort study of patients from five European urologic centers with a total PSA (tPSA) range of 2-10 ng/ml who were subjected to initial prostate biopsy for suspected PCa.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was to evaluate the specificity, sensitivity, and diagnostic accuracy of index tests in determining the presence of PCa at prostate biopsy in comparison to tPSA, fPSA, and percentage of fPSA to tPSA (%fPSA) (standard tests) and the number of prostate biopsies that could be spared using these tests. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis.RESULTS AND LIMITATIONS: Of >646 patients, PCa was diagnosed in 264 (40.1%). Median tPSA (5.7 vs 5.8 ng/ml; p=0.942) and p2PSA (15.0 vs 14.7 pg/ml) did not differ between groups; conversely, median fPSA (0.7 vs 1 ng/ml; p<0.001), %fPSA (0.14 vs 0.17; p<0.001), %p2PSA (2.1 vs 1.6; p<0.001), and PHI (48.2 vs 38; p<0.001) did differ significantly between men with and without PCa. In multivariable logistic regression models, p2PSA, %p2PSA, and PHI significantly increased the accuracy of the base multivariable model by 6.4%, 5.6%, and 6.4%, respectively (all p<0.001). At a PHI cut-off of 27.6, a total of 100 (15.5%) biopsies could have been avoided. The main limitation is that cases were selected on the basis of their initial tPSA values.CONCLUSIONS: In patients with a tPSA range of 2-10 ng/ml, %p2PSA and PHI are the strongest predictors of PCa at initial biopsy and are significantly more accurate than tPSA and %fPSA.
KW - Adenocarcinoma
KW - Aged
KW - Biopsy
KW - Cohort Studies
KW - Diagnostic Errors
KW - Humans
KW - Kallikreins
KW - Logistic Models
KW - Male
KW - Middle Aged
KW - Multivariate Analysis
KW - Predictive Value of Tests
KW - Prospective Studies
KW - Prostate
KW - Prostate-Specific Antigen
KW - Prostatic Neoplasms
KW - Protein Precursors
KW - ROC Curve
KW - Tumor Markers, Biological
U2 - 10.1016/j.eururo.2013.01.011
DO - 10.1016/j.eururo.2013.01.011
M3 - SCORING: Journal article
C2 - 23375961
VL - 63
SP - 986
EP - 994
JO - EUR UROL
JF - EUR UROL
SN - 0302-2838
IS - 6
ER -