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J Urol. 2018 Jun;199(6):1459-1463. doi: 10.1016/j.juro.2017.11.113. Epub 2017 Dec 6.

A Multi-Institutional Prospective Trial Confirms Noninvasive Blood Test Maintains Predictive Value in African American Men.

Author information

1
Department of Urology, University of Miami and Miami Veterans Affairs Medical Center, Miami, Florida. Electronic address: s.punnen@miami.edu.
2
Cedars-Sinai Medical Center, Los Angeles, California; Durham Veterans Affairs Medical Center, Durham, North Carolina.
3
Durham Veterans Affairs Medical Center, Durham, North Carolina; Duke Cancer Institute, Durham, North Carolina.
4
Department of Urology and Population Health, New York University and Manhattan Veterans Affairs Medical Center, New York, New York.
5
Department of Urology, University of Minnesota and Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota.
6
Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.
7
Pathology and Laboratory Medicine Service, Kansas City Veterans Affairs Medical Center, Kansas City, Missouri.
8
Department of Urology, University of California-Irvine, Irvine, California; Veterans Affairs Long Beach Health System, Long Beach, California.
9
OPKO Diagnostics, Woburn, Massachusetts.
10
Tulane University School of Medicine and Southeast Louisiana Veterans Health Care Center, New Orleans, Louisiana.

Abstract

PURPOSE:

The 4KscoreĀ® test accurately detects aggressive prostate cancer and reduces unnecessary biopsies. However, its performance in African American men has been unknown. We assessed test performance in a cohort of men with a large African American representation.

MATERIALS AND METHODS:

Men referred for prostate biopsy at 8 Veterans Affairs medical centers were prospectively enrolled in the study. All men underwent phlebotomy for 4Kscore test assessment prior to prostate biopsy. The primary outcome was the detection of Grade Group 2 or higher cancer on biopsy. We assessed the discrimination, calibration and clinical usefulness of 4Kscore to predict Grade Group 2 or higher prostate cancer and compared it to a base model consisting of age, digital rectal examination and prostate specific antigen. Additionally, we compared test performance in African American and nonAfrican American men.

RESULTS:

Of the 366 enrolled men 205 (56%) were African American and 131 (36%) had Grade Group 2 or higher prostate cancer. The 4Kscore test showed better discrimination (AUC 0.81 vs 0.74, p <0.01) and higher clinical usefulness on decision curve analysis than the base model. Test prediction closely approximated the observed risk of Grade Group 2 or higher prostate cancer. There was no difference in test performance in African American and nonAfrican American men (0.80 vs 0.84, p = 0.32), The test outperformed the base model in each group.

CONCLUSIONS:

The 4Kscore test accurately predicts aggressive prostate cancer for biopsy decision making in African American and nonAfrican American men.

KEYWORDS:

African Americans; biomarkers; kallikreins; neoplasm grading; prostatic neoplasms; tumor

PMID:
29223389
DOI:
10.1016/j.juro.2017.11.113

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