Clinical performance of serum prostate-specific antigen isoform [-2]proPSA (p2PSA) and its derivatives, %p2PSA and the prostate health index (PHI), in men with a family history of prostate cancer: results from a multicentre European study, the PROMEtheuS

2013 ◽  
Vol 112 (3) ◽  
pp. 313-321 ◽  
Author(s):  
Massimo Lazzeri ◽  
Alexander Haese ◽  
Alberto Abrate ◽  
Alexandre de la Taille ◽  
Joan Palou Redorta ◽  
...  
2016 ◽  
Vol 15 (13) ◽  
pp. e1562 ◽  
Author(s):  
A. Sanchis-Bonet ◽  
N. Morales-Palacios ◽  
M. Barrionuevo-González ◽  
L.E. Ortega-Polledo ◽  
J.C. Tamayo-Ruiz ◽  
...  

Author(s):  
Manuel M. Garrido ◽  
José C. Marta ◽  
Rui M. Bernardino ◽  
João Guerra ◽  
Francisco Fernandes ◽  
...  

Context.— There is a need to avoid the overdiagnosis of prostate cancer (PCa) and to find more specific biomarkers. Objective.— To evaluate the clinical utility of [−2]pro–prostate-specific antigen ([−2]proPSA) derivatives in detecting clinically significant PCa (csPCa) and to compare it with prostate-specific antigen (PSA) and with the percentage of free PSA (%fPSA). Design.— Two hundred thirty-seven men (PSA: 2–10 ng/mL) scheduled for a prostate biopsy were enrolled. Parametric and nonparametric tests, receiver operating characteristic (ROC) curves, and logistic regression analysis were applied. Outcomes were csPCa and overall PCa. Results.— Both [−2]proPSA derivatives were significantly higher in csPCa and overall PCa (P < .001). The areas under the curves for the prediction of csPCa were higher for the percentage of [−2]proPSA (%[−2]proPSA) (0.781) and the prostate health index (PHI) (0.814) than for PSA (0.651) and %fPSA (0.724). There was a gain of 11% in diagnostic accuracy when %[−2]proPSA or PHI were added to a base model with PSA and %fPSA. Twenty-five percent to 29% of biopsies could have been spared with %[−2]proPSA (cutoff: ≥1.25%) and PHI (cutoff: ≥27), missing 10% of csPCa's. The same results could have been achieved by using [−2]proPSA as a reflex test, when %fPSA was 25% or less (cutoffs: ≥1.12% and ≥24 for %[−2]proPSA and PHI, respectively). Conclusions.— The [−2]proPSA derivatives improve the diagnostic accuracy of csPCa, when the PSA value is between 2 and 10 ng/mL, allowing to spare unnecessary biopsies and to select patients for active surveillance. [−2]proPSA can be used as a reflex test when %fPSA is 25% or less, without reducing the diagnostic accuracy for csPCa and the number of spared biopsies.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5074-5074
Author(s):  
Martin Boegemann ◽  
Sebastien Vincendeau ◽  
Carsten Stephan ◽  
Alain Houlgatte ◽  
Laura-Maria Krabbe ◽  
...  

5074 Background: Although prostate-specific antigen (tPSA) screening reduced prostate cancer (PCa) mortality recent recommendations do not endorse PSA-screening due to overdiagnosis and overtreatment and the resulting harm afflicted to patients. Screening studies showed the maximum benefit in young men < 65 years of age. tPSA and percent free PSA (%fPSA) lack specifity in the diagnosis of PCa. [-2]proPSA and the prostate health index (phi) improved this diagnostic specifity. Markers to diagnose clinicaly relevant cancers in young men are needed. Methods: The clinical performance of [-2]proPSA and phi was evaluated in a multicenter study. A total of 1362 patients scheduled for initial or repeated prostate biopsy (668 with, 694 without PCa, each ≥ 10 core biopsies) were recruited in 4 different sites based on PSA level 1.6 – 8.0 ng/mL WHO-calibrated (2-10 ng/mL classically calibrated). Serum samples taken prior to digital rectal examination (DRE) were measured for the concentration of tPSA, fPSA and [-2]proPSA with Beckman Coulter immunoassays on Access 2 or DxI800 instruments. Phi was calculated as [-2]proPSA/fPSA*√tPSA. Results: In univariate analysis [-2]proPSA/fPSA (%[-2]proPSA) and phi were the best predictors of PCa detection in patients at initial biopsy (AUC: 0,72 and 0,73) and repeated biopsy (AUC: 0,74 and 0,74). Analysis of the data for men ≤ 65 years of age (n=593) showed that %[-2]proPSA and phi significantly improved PCa dectection (AUC: 0,72 and 0,73) as compared with tPSA (AUC: 0,54) or %fPSA (AUC: 0,62). In the detection of significant PCa (based on PRIAS criteria) %[-2]proPSA and phi demonstrated the best performance in the whole cohort and in young men (≤ 65) years as well (AUC 0,68 and 0,73). Conclusions: This multicenter study showed that [-2]proPSA and phi have a superior clinical performance in detecting PCa in the PSA range of 2-10 ng/mL compared with tPSA and %fPSA at initial and repeated biopsies. This superiority is maintained for the detection of PCa in young men (≤ 65 years of age).


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