Investig Clin Urol.  2016 Sep;57(5):336-342. 10.4111/icu.2016.57.5.336.

Extended use of Prostate Health Index and percentage of [-2]pro-prostate-specific antigen in Chinese men with prostate specific antigen 10–20 ng/mL and normal digital rectal examination

• Chiu PK
• Teoh JY
• Lee WM
• Yee CH
• Chan ES
• Hou SM
• Ng CF

• KMID: 2427012
• DOI: http://doi.org/10.4111/icu.2016.57.5.336

Abstract

PURPOSE
We investigated the extended use of Prostate Health Index (PHI) and percentage of [-2]pro-prostate-specific antigen (%p2PSA) in Chinese men with prostate-specific antigen (PSA) 10-20 ng/mL and normal digital rectal examination (DRE).
MATERIALS AND METHODS
All consecutive Chinese men with PSA 10-20 ng/mL and normal DRE who agreed for transrectal ultrasound (TRUS)-guided 10-core prostate biopsy were recruited. Blood samples were taken immediately before TRUS-guided prostate biopsy. The performances of total PSA (tPSA), %free-to-total PSA (%fPSA), %p2PSA, and PHI were compared using logistic regression, receiver operating characteristic, and decision curve analyses (DCA).
RESULTS
From 2008 to 2015, 312 consecutive Chinese men were included. Among them, 53 out of 312 (17.0%) men were diagnosed to have prostate cancer on biopsy. The proportions of men with positive biopsies were 6.7% in PHI < 35, 22.8% in PHI 35-55, and 54.5% in PHI>55 (chi-square test, p < 0.001). The area under curves (AUC) of the base model including age, tPSA and status of initial/repeated biopsy was 0.64. Adding %p2PSA and PHI to the base model improved the AUC to 0.79 (p < 0.001) and 0.78 (p < 0.001), respectively, and provided net clinical benefit in DCA. The positive biopsy rates of Gleason 7 or above prostate cancers were 2.2% for PHI < 35, 7.9% for PHI 35-55, and 36.4% for PHI>55 (chi-square test, p < 0.001). By utilizing the PHI cutoff of 35 to men with PSA 10-20 ng/mL and normal DRE, 57.1% (178 of 312) biopsies could be avoided.
CONCLUSIONS
Both PHI and %p2PSA performed well in predicting prostate cancer and high grade prostate cancer. The use of PHI and %p2PSA should be extended to Chinese men with PSA 10-20 ng/mL and normal DRE.

Keyword

Biomarkers; Biopsy; Prostate; Prostate neoplasms; Prostate-specific antigen

MeSH Terms

Aged
Aged, 80 and over
Biopsy, Large-Core Needle/methods
*Digital Rectal Examination
Humans
Male
Middle Aged
Predictive Value of Tests
Prospective Studies
Prostate-Specific Antigen/*blood
Prostatic Neoplasms/*diagnosis/pathology
Protein Precursors/blood
ROC Curve
Ultrasonography, Interventional/methods
Protein Precursors

Figure

• 

  Fig. 1 Decision curve analysis for prediction of prostate cancer diagnosis, comparing total prostate-specific antigen (PSA), %free-to-total PSA (%fPSA), percentage of [-2]pro-prostate-specific antigen (%p2PSA), and Prostate Health Index (PHI). X-axis (threshold probability) is the probability of prostate cancer diagnosis that the patient would opt for prostate biopsy. Y-axis is the net clinical benefit for different models.

• 

  Fig. 2 Decision curve analysis for prediction of prostate cancer diagnosis, comparing base model, base model+%free-to-total PSA (%fPSA), base model+percentage of [-2]pro-prostate-specific antigen (%p2PSA), and base model+Prostate Health Index (PHI). Base model included age, total PSA, and status of initial/repeated biopsy. X-axis (threshold probability) is the probability of prostate cancer diagnosis that the patient would opt for prostate biopsy. Y-axis is the net clinical benefit for different models.

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