A Multi-institutional Prospective Trial in the Veterans Affairs Health System confirms the 4Kscore maintains its Predictive value among African American Men

The 4Kscore test accurately detects aggressive prostate cancer and reduces unnecessary biopsies, however, its performance in African American (AA) men is unknown. This study assessed the performance of the 4Kscore test in a cohort of men with a large AA representation.

Men referred for a biopsy of the prostate at eight Veteran's Affairs Medical centers were prospectively enrolled. All men underwent phlebotomy for 4Kscore test assessment prior to biopsy of the prostate. The primary outcome was the detection of Grade Group 2 (GG2) or higher cancer on biopsy. We assessed the discrimination, calibration, and clinical utility of the 4Kscore test for predicting GG2 or higher prostate cancer, and compared it to a base model consisting of age, digital rectal exam, and PSA. Additionally, we compared the performance of the 4Kscore test in AA and non-AA men.

Among the 366 men enrolled, 205 (56%) were AA, and 131 (36%) had GG2 or higher prostate cancer. The 4Kscore test exhibited better discrimination (AUC: 0.81 vs. 0.74, p<0.01) and higher clinical utility on decision curve analysis than the base model. The 4Kscore test prediction closely approximated the observed risk of GG2 or higher prostate cancer. There was no difference in the performance of the 4Kscore test in AA and non-AA men (0.80 vs. 0.84; p=0.32), and the 4Kscore outperformed the base model in both groups.

The 4Kscore test accurately predicts aggressive prostate cancer for biopsy decision making in both AA and non-AA men.

The Journal of urology. 2017 Dec 06 [Epub ahead of print]

Sanoj Punnen, Stephen J Freedland, Thomas J Polascik, Stacy Loeb, Michael C Risk, Stephen Savage, Sharad C Mathur, Edward Uchio, Yan Dong, Jonathan L Silberstein

Department of Urology, University of Miami and Miami Veterans Affairs Medical Center. Electronic address: ., Cedars-Sinai Medical Center and Durham Veterans Affairs Medical Center., Duke Cancer Institute and Durham Veterans Affairs Medical Center., Department of Urology and Population Health, New York University and Manhattan Veterans Affairs Medical Center., Department of Urology, University of Minnesota and Minneapolis Veterans Affairs Medical Center., Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center., Pathology and Laboratory Medicine Service, Kansas City Veterans Affairs Medical Center., Department of Urology, University of California, Irvine and Veterans Affairs Long Beach Health System., OPKO Diagnostics., Tulane University School of Medicine and Southeast Louisiana Veterans Health Care Center.

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