Prostate-Specific Antigen (PSA) Isoform p2PSA in Combination with Total PSA and Free PSA Improves Diagnostic Accuracy in Prostate Cancer Detection

Jansen, Frank-Willem; Schaik, Ron H.N. van; Kurstjens, Joep; Horninger, Wolfgang; Klocker, Helmut; Bektic, Jasmin; Wildhagen, Mark F.; Roobol, Monique J.; Bangma, Chris H.; Bartsch, Georg

doi:10.1016/j.eururo.2010.02.003

Cited by 226 publications

(171 citation statements)

References 20 publications

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“…All patients underwent TRUS-guided biopsy with at least 8 cores (range [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Local pathology institutions performed histological analysis and Gleason score grading.…”

Section: Methodsmentioning

confidence: 99%

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The percentage of prostate‐specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

Boegemann¹,

Stephan

Cammann

et al. 2015

BJU International

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ObjectivesTo prospectively test the diagnostic accuracy of the percentage of prostate specific antigen (PSA) isoform [-2]proPSA (%p2PSA) and the Prostate Health Index (PHI), and to determine their role for discrimination between significant and insignificant prostate cancer at initial and repeat prostate biopsy in men aged ≤65 years. Patients and MethodsThe diagnostic performance of %p2PSA and PHI were evaluated in a multicentre study. In all, 769 men aged ≤65 years scheduled for initial or repeat prostate biopsy were recruited in four sites based on a total PSA (t-PSA) level of 1.6-8.0 ng/mL World Health Organization (WHO) calibrated (2-10 ng/mL Hybritechcalibrated). Serum samples were measured for the concentration of t-PSA, free PSA (f-PSA) and p2PSA with Beckman Coulter immunoassays on Access-2 or DxI800 instruments. PHI was calculated as (p2PSA/f-PSA 9 √t-PSA). Uni-and multivariable logistic regression models and an artificial neural network (ANN) were complemented by decision curve analysis (DCA). ResultsIn univariate analysis %p2PSA and PHI were the best predictors of prostate cancer detection in all patients In multivariate analysis PHI we added to a base model of age, prostate volume, digital rectal examination, t-PSA and %f-PSA. PHI was strongest in predicting prostate cancer in all patients, at initial and repeat biopsy and for significant prostate cancer (AUC 0.73, 0.68, 0.78 and 0.72, respectively). In DCA for all patients the ANN showed the broadest threshold probability and best net benefit. PHI as single parameter and the base model + PHI were equivalent with threshold probability and net benefit nearing those of the ANN. For significant cancers the ANN was the strongest parameter in DCA. ConclusionThe present multicentre study showed that %p2PSA and PHI have a superior diagnostic performance for detecting prostate cancer in the PSA range of 1.6-8.0 ng/mL compared with t-PSA and %f-PSA at initial and repeat biopsy and for predicting significant prostate cancer in men aged ≤65 years. They are equally superior for counselling patients before biopsy.

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Section: Methodsmentioning

confidence: 99%

“…Based on p2PSA, the 'Prostate Health Index' (PHI) has been developed (a formula that includes p2PSA, f-PSA and t-PSA) and PHI was shown to improve the diagnostic accuracy for prostate cancer [14,15].…”

Section: Introductionmentioning

confidence: 99%

The percentage of prostate‐specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

Boegemann¹,

Stephan

Cammann

et al. 2015

BJU International

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“…19,20 Access Hybritech p2PSA has being investigated for use with Access Hybritech PSA and fPSA to calculate a multivariate index developed by Beckman Coulter (Brea, CA, USA) to determine the individuals' relative risk of prostate cancer. [21][22][23] Currently, a multicenter clinical study in the United States sponsored by Beckman Coulter suggests that, at 95% sensitivity, this prostate cancer risk index doubled the specificity of prostate cancer detection relative to %fPSA for individuals with PSA 2-10 ng ml À1 (ref. 21).…”

Section: Introductionmentioning

confidence: 99%

“…13,29,30,[43][44][45] Therefore, the 2009 AUA PSA Best Practice Policy 3 emphasizes that the prostate biopsy decision should consider PSA and digital rectal examination results, as well as multiple factors. Two recent studies 22,23 reported that a mathematical formula combining total PSA, fPSA and p2PSA to calculate the index shows improved specificity for detecting prostate cancer. Jansen et al 22 reported a specificity of 31% for the index at 90% sensitivity, compared with total PSA (10%) and %fPSA (12%).…”

mentioning

confidence: 99%

“…Two recent studies 22,23 reported that a mathematical formula combining total PSA, fPSA and p2PSA to calculate the index shows improved specificity for detecting prostate cancer. Jansen et al 22 reported a specificity of 31% for the index at 90% sensitivity, compared with total PSA (10%) and %fPSA (12%). Comprehensive prostate cancer risk calculators have been developed to assess individual risk 32,46 of cancer or need for biopsy and follow-up.…”

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Budget impact analysis of a new prostate cancer risk index for prostate cancer detection

Nichol

et al. 2011

Prostate Cancer Prostatic Dis

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The objective of this study was to evaluate the budget impact of a new prostate cancer risk index for detecting prostate cancer. The index is calculated as the combination of serum prostate-specific antigen (PSA), free PSA and a precursor form p2PSA. We constructed two budget impact models using PSA cutoff values of X2 ng ml À1 (model #1) and X4 ng ml À1 (model #2) for recommending a prostate biopsy in a hypothetical health plan with 100 000 male members aged 50-75 years old. The budgetary impact on the 1-year expected total costs for prostate cancer detection was calculated. Adding the index to the current PSA prostate cancer testing strategies including the total PSA and percent free PSA, the number of detected cancer cases decreased by 20 and 5, in models #1 and #2, respectively. The savings on expected 1-year cost for prostate cancer detection were $356 647 (or $0.30 per-member-per-month (PMPM)) in model #1 and $94 219 ($0.08 PMPM) in model #2. The index produced higher cost savings in the model #1 with PSA cutoff X2 ng ml À1 than the model #2 with cutoff X4 ng ml À1 with a small short-term reduction in the number of positive tests.

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Hospital Salt

Satin¹

2013

JAMA Intern Med

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Prostate-Specific Antigen (PSA) Isoform p2PSA in Combination with Total PSA and Free PSA Improves Diagnostic Accuracy in Prostate Cancer Detection

Cited by 226 publications

References 20 publications

The percentage of prostate‐specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

The percentage of prostate‐specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

Budget impact analysis of a new prostate cancer risk index for prostate cancer detection

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