The prostate health index selectively identifies clinically significant prostate cancer

Stacy Loeb; Martin G. Sanda; Dennis L. Broyles; Sanghyuk S. Shin; Chris H. Bangma; John T. Wei; Alan W. Partin; George G. Klee; Kevin M. Slawin; Leonard S. Marks; Ron H.N. Van Schaik; Daniel W. Chan; Lori J. Sokoll; Amabelle B. Cruz; Isaac A. Mizrahi; William J. Catalona

doi:10.1016/j.juro.2014.10.121

The prostate health index selectively identifies clinically significant prostate cancer

Stacy Loeb, Martin G. Sanda, Dennis L. Broyles, Sanghyuk S. Shin, Chris H. Bangma, John T. Wei, Alan W. Partin, George G. Klee, Kevin M. Slawin, Leonard S. Marks, Ron H.N. Van Schaik, Daniel W. Chan, Lori J. Sokoll, Amabelle B. Cruz, Isaac A. Mizrahi, William J. Catalona

Laboratory Medicine and Pathology

Research output: Contribution to journal › Article › peer-review

142 Scopus citations

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 prostate 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 prostate 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.

Original language	English (US)
Pages (from-to)	1163-1169
Number of pages	7
Journal	Journal of Urology
Volume	193
Issue number	4
DOIs	https://doi.org/10.1016/j.juro.2014.10.121
State	Published - Apr 1 2015

Keywords

biological markers
early detection of cancer
prostatic neoplasms

ASJC Scopus subject areas

Urology

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10.1016/j.juro.2014.10.121

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Loeb, S., Sanda, M. G., Broyles, D. L., Shin, S. S., Bangma, C. H., Wei, J. T., Partin, A. W., Klee, G. G., Slawin, K. M., Marks, L. S., Van Schaik, R. H. N., Chan, D. W., Sokoll, L. J., Cruz, A. B., Mizrahi, I. A., & Catalona, W. J. (2015). The prostate health index selectively identifies clinically significant prostate cancer. Journal of Urology, 193(4), 1163-1169. https://doi.org/10.1016/j.juro.2014.10.121

Loeb, S, Sanda, MG, Broyles, DL, Shin, SS, Bangma, CH, Wei, JT, Partin, AW, Klee, GG, Slawin, KM, Marks, LS, Van Schaik, RHN, Chan, DW, Sokoll, LJ, Cruz, AB, Mizrahi, IA & Catalona, WJ 2015, 'The prostate health index selectively identifies clinically significant prostate cancer', Journal of Urology, vol. 193, no. 4, pp. 1163-1169. https://doi.org/10.1016/j.juro.2014.10.121

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title = "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 prostate 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 prostate 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.",

keywords = "biological markers, early detection of cancer, prostatic neoplasms",

author = "Stacy Loeb and Sanda, {Martin G.} and Broyles, {Dennis L.} and Shin, {Sanghyuk S.} and Bangma, {Chris H.} and Wei, {John T.} and Partin, {Alan W.} and Klee, {George G.} and Slawin, {Kevin M.} and Marks, {Leonard S.} and {Van Schaik}, {Ron H.N.} and Chan, {Daniel W.} and Sokoll, {Lori J.} and Cruz, {Amabelle B.} and Mizrahi, {Isaac A.} and Catalona, {William J.}",

note = "Publisher Copyright: {\textcopyright} 2015 American Urological Association Education and Research, Inc.",

year = "2015",

month = apr,

day = "1",

doi = "10.1016/j.juro.2014.10.121",

language = "English (US)",

volume = "193",

pages = "1163--1169",

journal = "Journal of Urology",

issn = "0022-5347",

publisher = "Elsevier Inc.",

number = "4",

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T1 - The prostate health index selectively identifies clinically significant prostate cancer

AU - Loeb, Stacy

AU - Sanda, Martin G.

AU - Broyles, Dennis L.

AU - Shin, Sanghyuk S.

AU - Bangma, Chris H.

AU - Wei, John T.

AU - Partin, Alan W.

AU - Klee, George G.

AU - Slawin, Kevin M.

AU - Marks, Leonard S.

AU - Van Schaik, Ron H.N.

AU - Chan, Daniel W.

AU - Sokoll, Lori J.

AU - Cruz, Amabelle B.

AU - Mizrahi, Isaac A.

AU - Catalona, William J.

PY - 2015/4/1

Y1 - 2015/4/1

N2 - 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 prostate 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 prostate 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.

AB - 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 prostate 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 prostate 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.

KW - biological markers

KW - early detection of cancer

KW - prostatic neoplasms

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The prostate health index selectively identifies clinically significant prostate cancer

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