Prostate Cancer

A Biopsy-based 17-gene Genomic Prostate Score Predicts Recurrence After Radical Prostatectomy and Adverse Surgical Pathology in a Racially Diverse Population of Men with Clinically Low- and Intermediate-risk Prostate Cancer

By: Jennifer Cullen a lowast , Inger L. Rosner b , Timothy C. Brand c , Nan Zhang d , Athanasios C. Tsiatis d , Joel Moncur b , Amina Ali a , Yongmei Chen a , Dejan Knezevic d , Tara Maddala d , H. Jeffrey Lawrence d , Phillip G. Febbo d , Shiv Srivastava a , Isabell A. Sesterhenn e and David G. McLeod b

European Urology, Volume 68 Issue 1, July 2015, Pages 123-131

Published online: 01 July 2015

Keywords: Clinical validation, Gene expression, Molecular diagnostic testing, Neoplasm recurrence, Prostate neoplasms

Abstract Full Text Full Text PDF (2,0 MB) Patient Summary



Biomarkers that are validated in independent cohorts are needed to improve risk assessment for prostate cancer (PCa).


A racially diverse cohort of men (20% African American [AA]) was used to evaluate the association of the clinically validated 17-gene Genomic Prostate Score (GPS) with recurrence after radical prostatectomy and adverse pathology (AP) at surgery.

Design, setting, and participants

Biopsies from 431 men treated for National Comprehensive Cancer Network (NCCN) very low-, low-, or intermediate-risk PCa between 1990 and 2011 at two US military medical centers were tested to validate the association between GPS and biochemical recurrence (BCR) and to confirm the association with AP. Metastatic recurrence (MR) was also evaluated.

Outcome measurements and statistical analysis

Cox proportional hazards models were used for BCR and MR, and logistic regression was used for AP. Central pathology review was performed by one uropathologist. AP was defined as primary Gleason pattern 4 or any pattern 5 and/or pT3 disease.

Results and limitations

GPS results (scale: 0–100) were obtained in 402 cases (93%); 62 men (15%) experienced BCR, 5 developed metastases, and 163 had AP. Median follow-up was 5.2 yr. GPS predicted time to BCR in univariable analysis (hazard ratio per 20 GPS units [HR/20 units]: 2.9;p < 0.001) and after adjusting for NCCN risk group (HR/20 units: 2.7;p < 0.001). GPS also predicted time to metastases (HR/20 units: 3.8;p = 0.032), although the event rate was low (n = 5). GPS was strongly associated with AP (odds ratio per 20 GPS units: 3.3;p < 0.001), adjusted for NCCN risk group. In AA and Caucasian men, the median GPS was 30.3 for both, the distributions of GPS results were similar, and GPS was similarly predictive of outcome.


The association of GPS with near- and long-term clinical end points establishes the assay as a strong independent measure of PCa aggressiveness. Tumor aggressiveness, as measured by GPS, and outcomes were similar in AA and Caucasian men in this equal-access health care system.

Patient summary

Predicting outcomes in men with newly diagnosed prostate cancer is challenging. This study demonstrates that a new molecular test, the Genomic Prostate Score, which can be performed on a patient's original prostate needle biopsy, can predict the aggressiveness of the cancer and help men make decisions regarding the need for immediate treatment of their cancer.

Take Home Message

A biopsy-based 17-gene assay is a strong, independent predictor of near- and long-term clinical outcomes including adverse surgical pathology and recurrence after surgery in both Caucasian and African American men with newly diagnosed clinically very low-, low-, or intermediate-risk prostate cancer.

Keywords: Clinical validation, Gene expression, Molecular diagnostic testing, Neoplasm recurrence, Prostate neoplasms.


a Center for Prostate Disease Research, Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, USA

b Walter Reed National Military Medical Center, Bethesda, MD, USA

c Madigan Army Medical Center, Tacoma, WA, USA

d Genomic Health, Inc., Redwood City, CA, USA

e Joint Pathology Center, Silver Spring, MD, USA

lowast Corresponding author. Department of Defense, Center for Prostate Disease Research, 1530 E. Jefferson Street, Rockville, MD 20852, USA. Tel. +1 240 453 8917; Fax: +1 240 453 8912.

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