The Prostate Health Index Selectively Identifies Clinically Significant Prostate Cancer

Abstract

Purpose The Prostate Health Index (phi) is a new test combining total, free and [-2]proPSA into a single score. It was recently approved by the FDA and is now commercially available in the U.S., Europe and Australia. We investigate whether phi improves specificity for detecting clinically significant prostate cancer and can help reduce prostate cancer over diagnosis. Materials and Methods From a multicenter prospective trial we identified 658 men age 50 years or older with prostate specific antigen 4 to 10 ng/ml and normal digital rectal examination who underwent prostate biopsy. In this population we compared the performance of prostate specific antigen, % free prostate specific antigen, [-2]proPSA and phi to predict biopsy results and, specifically, the presence of clinically significant prostate cancer using multiple criteria. Results The Prostate Health Index was significantly higher in men with Gleason 7 or greater and “Epstein significant” cancer. On receiver operating characteristic analysis phi had the highest AUC for overall cancer (AUCs phi 0.708, percent free prostate specific antigen 0.648, [-2]proPSA 0.550 and prostate specific antigen 0.516), Gleason 7 or greater (AUCs phi 0.707, percent free prostate specific antigen 0.661, [-2]proPSA 0.558, prostate specific antigen 0.551) and significant cancer (AUCs phi 0.698, percent free prostate specific antigen 0.654, [-2]proPSA 0.550, prostate specific antigen 0.549). At the 90% sensitivity cut point for phi (a score less than 28.6) 30.1% of patients could have been spared an unnecessary biopsy for benign disease or insignificant prostate cancer compared to 21.7% using percent free prostate specific antigen. Conclusions The new phi test outperforms its individual components of total, free and [-2]proPSA for the identification of clinically significant prostate cancer. Phi may be useful as part of a multivariable approach to reduce prostate biopsies and over diagnosis.

Prostate Health Index (PHI) Predicts High-stage Pathology in African American Men

“…The largest AA population identified in the literature includes 57 men, but race was not considered in this assessment. 6 In a separate study, Catalona and colleagues identified no significant difference in age, PSA, p2PSA, %fPSA, or PHI between Caucasians and AA men with a PSA between 2 and 10 ng/mL; however, they did not assess racial differences when examining prostate biopsy pathology. 2 There is a need to better understand how PHI and other biomarkers can be utilized in the AA population, as multiple studies have demonstrated higher rates of non-organ-confined disease, GS upgrading, positive surgical margins, and BCR after RP in AA men.…”

“…[2][3][4][5][6][7][8][9][10][11][12] Although promising data exist within the overall population, little is known about the use of PHI in the AA population. Our findings demonstrate that PHI obtained at or soon after diagnosis was significantly higher in AA men found to have pT3 on surgical pathology.…”

Canadian Urological Association recommendations on prostate cancer screening and early diagnosis

“…78 Subsequent validation studies have confirmed this finding, showing that PHI can outperform total and percent free PSA in predicting high-risk disease, including in biopsy-naive men. 79,80 Additionally, in a large, multicentre, prospective study, PHI significantly improved the performance of the PCPT and ERSPC risk calculators (see below) in men with a PSA between 2 and 10 ng/ml for predicting the risk of Gleason ≥7 prostate cancer. 81 A multicentre cohort study evaluating the clinical utility of PHI found that it reduced unnecessary biopsies by 36% and only missed 2.5% of highgrade cancers.…”

Prostate cancer: unmet clinical needs and RAD9 as a candidate biomarker for patient management

“…The Prostate Health Index ( phi ) is commercialized by Beckman Coulter Inc. and is an U.S. Food & Drug Administration (FDA) approved blood test used as an aid in distinguishing prostate cancer from benign prostatic conditions [www.beckmancoulter.com; (6)]. It is a calculation based on an algorithm combining total PSA, free PSA, and another form of PSA, namely [-2]proPSA.…”