Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay.
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Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay. / Hansen, Jens; Auprich, Marco; Ahyai, Sascha A; de la Taille, Alexandre; van Poppel, Hendrik; Marberger, Michael; Stenzl, Arnulf; Mulders, Peter F A; Huland, Hartwig; Fisch, Margit; Abbou, Clement-Claude; Schalken, Jack A; Fradet, Yves; Marks, Leonard S; Ellis, William; Partin, Alan W; Pummer, Karl; Graefen, Markus; Haese, Alexander; Walz, Jochen; Briganti, Alberto; Shariat, Shahrokh F; Chun, Felix K.
In: EUR UROL, Vol. 63, No. 2, 2, 2013, p. 201-209.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay.
AU - Hansen, Jens
AU - Auprich, Marco
AU - Ahyai, Sascha A
AU - de la Taille, Alexandre
AU - van Poppel, Hendrik
AU - Marberger, Michael
AU - Stenzl, Arnulf
AU - Mulders, Peter F A
AU - Huland, Hartwig
AU - Fisch, Margit
AU - Abbou, Clement-Claude
AU - Schalken, Jack A
AU - Fradet, Yves
AU - Marks, Leonard S
AU - Ellis, William
AU - Partin, Alan W
AU - Pummer, Karl
AU - Graefen, Markus
AU - Haese, Alexander
AU - Walz, Jochen
AU - Briganti, Alberto
AU - Shariat, Shahrokh F
AU - Chun, Felix K
N1 - Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.
PY - 2013
Y1 - 2013
N2 - BACKGROUND: Urinary prostate cancer antigen 3 (PCA3) assay in combination with established clinical risk factors improves the identification of men at risk of harboring prostate cancer (PCa) at initial biopsy (IBX).OBJECTIVE: To develop and validate internally the first IBX-specific PCA3-based nomogram that allows an individual assessment of a man's risk of harboring any PCa and high-grade PCa (HGPCa).DESIGN, SETTING, AND PARTICIPANTS: Clinical and biopsy data including urinary PCA3 score of 692 referred IBX men at risk of PCa were collected within two prospective multi-institutional studies.INTERVENTION: IBX (≥ 10 biopsy cores) with standard risk factor assessment including prebiopsy urinary PCA3 measurement.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PCA3 assay cut-off thresholds were investigated. Regression coefficients of logistic risk factor analyses were used to construct specific sets of PCA3-based nomograms to predict any PCa and HGPCa at IBX. Accuracy estimates for the presence of any PCa and HGPCa were quantified using area under the curve of the receiver operator characteristic analysis and compared with a clinical model. Bootstrap resamples were used for internal validation. Decision curve analyses quantified the clinical net benefit related to the novel PCA3-based IBX nomogram versus the clinical model.RESULTS AND LIMITATIONS: Any PCa and HGPCa were diagnosed in 46% (n=318) and 20% (n=137), respectively. Age, prostate-specific antigen, digital rectal examination, prostate volume, and PCA3 were independent predictors of PCa at IBX (all p<0.001). The PCA3-based IBX nomograms significantly outperformed the clinical models without PCA3 (all p<0.001). Accuracy was increased by 4.5-7.1% related to PCA3 inclusion. When applying nomogram-derived PCa probability thresholds ≤ 30%, only a few patients with HGPCa (≤ 2%) will be missed while avoiding up to 55% of unnecessary biopsies. External validation of the PCA3-based IBX-specific nomogram is warranted.CONCLUSIONS: The internally validated PCA3-based IBX-specific nomogram outperforms a clinical prediction model without PCA3 for the prediction of any PCa, leading to the avoidance of unnecessary biopsies while missing only a few cases of HGPCa. Our findings support the concepts of a combination of novel markers with established clinical risk factors and the superiority of decision tools that are specific to a clinical scenario.
AB - BACKGROUND: Urinary prostate cancer antigen 3 (PCA3) assay in combination with established clinical risk factors improves the identification of men at risk of harboring prostate cancer (PCa) at initial biopsy (IBX).OBJECTIVE: To develop and validate internally the first IBX-specific PCA3-based nomogram that allows an individual assessment of a man's risk of harboring any PCa and high-grade PCa (HGPCa).DESIGN, SETTING, AND PARTICIPANTS: Clinical and biopsy data including urinary PCA3 score of 692 referred IBX men at risk of PCa were collected within two prospective multi-institutional studies.INTERVENTION: IBX (≥ 10 biopsy cores) with standard risk factor assessment including prebiopsy urinary PCA3 measurement.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PCA3 assay cut-off thresholds were investigated. Regression coefficients of logistic risk factor analyses were used to construct specific sets of PCA3-based nomograms to predict any PCa and HGPCa at IBX. Accuracy estimates for the presence of any PCa and HGPCa were quantified using area under the curve of the receiver operator characteristic analysis and compared with a clinical model. Bootstrap resamples were used for internal validation. Decision curve analyses quantified the clinical net benefit related to the novel PCA3-based IBX nomogram versus the clinical model.RESULTS AND LIMITATIONS: Any PCa and HGPCa were diagnosed in 46% (n=318) and 20% (n=137), respectively. Age, prostate-specific antigen, digital rectal examination, prostate volume, and PCA3 were independent predictors of PCa at IBX (all p<0.001). The PCA3-based IBX nomograms significantly outperformed the clinical models without PCA3 (all p<0.001). Accuracy was increased by 4.5-7.1% related to PCA3 inclusion. When applying nomogram-derived PCa probability thresholds ≤ 30%, only a few patients with HGPCa (≤ 2%) will be missed while avoiding up to 55% of unnecessary biopsies. External validation of the PCA3-based IBX-specific nomogram is warranted.CONCLUSIONS: The internally validated PCA3-based IBX-specific nomogram outperforms a clinical prediction model without PCA3 for the prediction of any PCa, leading to the avoidance of unnecessary biopsies while missing only a few cases of HGPCa. Our findings support the concepts of a combination of novel markers with established clinical risk factors and the superiority of decision tools that are specific to a clinical scenario.
KW - Humans
KW - Male
KW - Aged
KW - Middle Aged
KW - Risk Factors
KW - Prospective Studies
KW - Cohort Studies
KW - Age Factors
KW - Reproducibility of Results
KW - Decision Support Techniques
KW - Organ Size
KW - Prostate-Specific Antigen/blood
KW - Nomograms
KW - Antigens, Neoplasm/urine
KW - Prostate/pathology
KW - Risk Assessment/methods
KW - Biological Markers/urine
KW - Biopsy, Large-Core Needle
KW - Digital Rectal Examination/statistics & numerical data
KW - Kallikreins/blood
KW - Prostatic Neoplasms/diagnosis
KW - Humans
KW - Male
KW - Aged
KW - Middle Aged
KW - Risk Factors
KW - Prospective Studies
KW - Cohort Studies
KW - Age Factors
KW - Reproducibility of Results
KW - Decision Support Techniques
KW - Organ Size
KW - Prostate-Specific Antigen/blood
KW - Nomograms
KW - Antigens, Neoplasm/urine
KW - Prostate/pathology
KW - Risk Assessment/methods
KW - Biological Markers/urine
KW - Biopsy, Large-Core Needle
KW - Digital Rectal Examination/statistics & numerical data
KW - Kallikreins/blood
KW - Prostatic Neoplasms/diagnosis
U2 - 10.1016/j.eururo.2012.07.030
DO - 10.1016/j.eururo.2012.07.030
M3 - SCORING: Journal article
C2 - 22854248
VL - 63
SP - 201
EP - 209
JO - EUR UROL
JF - EUR UROL
SN - 0302-2838
IS - 2
M1 - 2
ER -
