Prostate-Specific Antigen (PSA) Isoform p2PSA Significantly Improves the Prediction of Prostate Cancer at Initial Extended Prostate Biopsies in Patients with Total PSA Between 2.0 and 10 ng/ml: Results of a Prospective Study in a Clinical Setting

Guazzoni, G.; Nava, Luciano; Lazzeri, Massimo; Scattoni, Vincenzo; Lughezzani, Giovanni; Maccagnano, Carmen; Dorigatti, Fernanda; Ceriotti, Ferruccio; Pontillo, Marina; Bini, Vittorio; Freschi, Massimo; Montorsi, Francesco; Rigatti, Patrìzio

doi:10.1016/j.eururo.2011.03.052

Cited by 176 publications

(157 citation statements)

References 16 publications

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“…Both PCA3 and PHI have been shown to improve discrimination between men with and without PCa, mainly in the tPSA range 2.5-10 ng/mL, and between cases of clinically significant and insignificant disease [12,13,15]. As for PCA3, the likelihood of positive PB is 17% for a score < 35, 43% for a score > 35, and 69% for a score > 100 [15].…”

Section: A Gallotta Et Al Cancer Treatment and Research Communicatimentioning

confidence: 98%

“…The proportion of PBs that could be spared if the index test had to be used in the decisional PB pathway was also calculated. Secondary endpoint was the correlation between iXip and PCa aggressiveness, which we defined as any Gleason score (GS)≥7 cancer, in line with previous similar diagnostic studies [12,13].…”

Section: Study Endpointsmentioning

confidence: 99%

“…Most of these cases were GS < 7 cancers. We acknowledge that the definition of tumor aggressiveness by GS ≥7 is prone to criticism, however it was used by two recent similar diagnostic studies [12,13]. iXip, as well as other novel markers, should be correlated with definitive pathology after radical prostatectomy, and, ideally, with oncological outcome after treatment.…”

Section: A Gallotta Et Al Cancer Treatment and Research Communicatimentioning

confidence: 99%

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Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients

Gallotta¹,

Giannarini

Laurini³

et al. 2017

Cancer Treatment and Research Communications

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Section: A Gallotta Et Al Cancer Treatment and Research Communicatimentioning

confidence: 98%

Section: Study Endpointsmentioning

confidence: 99%

Section: A Gallotta Et Al Cancer Treatment and Research Communicatimentioning

confidence: 99%

See 1 more Smart Citation

Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients

Gallotta¹,

Giannarini

Laurini³

et al. 2017

Cancer Treatment and Research Communications

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“…Several early reports on serum p2PSA and PHI found an increased positive predictive value of p2PSA and PHI compared with t-PSA or the percentage of f-PSA (%f-PSA) [15][16][17][18][19][20]. Earlier our own results on a cohort of 1 362 men with an unrestricted age range showed a superior clinical performance for %p2PSA and PHI as compared with t-PSA and %f-PSA in detecting prostate cancer and clinically significant prostate cancer in a t-PSA range between 1.6 and 8.0 ng/mL [21].…”

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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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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“…Cut-off values for biopsy decisions using %p2PSA (p2PSA/free PSA) and PHI are not yet universally accepted and differ with regard to free PSA and total PSA calibration method (Hybritech or WHO), but it seems PHI values above 40 or 45 indicate high and below 21 low risk of prostate cancer. PHI of more than 48.5 was reported as 43% specific at 90% sensitive for detecting prostate cancer at initial prostate biopsy (Guazzoni et al, 2011). Another study reported PHI values above 34.2 to show increased probability for high risk disease (Isharwal et al, 2011).…”

mentioning

confidence: 94%

Future of Prostate Biopsy: Who Will Get It and How?

Hajdinjak¹

2011

Prostate Cancer - Diagnostic and Therapeutic Advances

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Prostate-Specific Antigen (PSA) Isoform p2PSA Significantly Improves the Prediction of Prostate Cancer at Initial Extended Prostate Biopsies in Patients with Total PSA Between 2.0 and 10 ng/ml: Results of a Prospective Study in a Clinical Setting

Cited by 176 publications

References 16 publications

Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients

Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients

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

Future of Prostate Biopsy: Who Will Get It and How?

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