. 2023 Aug 31;7(5):pkad052.

doi: 10.1093/jncics/pkad052.

Use of the Decipher genomic classifier among men with prostate cancer in the United States

Nicholas G Zaorsky^{1

2}, James A Proudfoot³, Angela Y Jia^{1

2}, Raed Zuhour^{1

2}, Randy Vince Jr^{1

2}, Yang Liu³, Xin Zhao³, Jim Hu⁴, Nicola C Schussler⁵, Jennifer L Stevens⁵, Suzanne Bentler⁶, Rosemary D Cress⁷, Jennifer A Doherty^{8

9}, Eric B Durbin¹⁰, Susan Gershman¹¹, Iona Cheng¹², Lou Gonsalves¹³, Brenda Y Hernandez¹⁴, Lihua Liu¹⁵, Bożena M Morawski¹⁶, Maria Schymura¹⁷, Stephen M Schwartz¹⁸, Kevin C Ward¹⁹, Charles Wiggins²⁰, Xiao-Cheng Wu²¹, Jonathan E Shoag^{1

2}, Lee Ponsky^{1

2}, Alan Dal Pra²², Edward M Schaeffer²³, Ashley E Ross²³, Yilun Sun², Elai Davicioni³, Valentina Petkov²⁴, Daniel E Spratt^{1

2}

Affiliations

¹ Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Cleveland, OH, USA.
² Department of Population and Quantitative Health Sciences, Case Western Reserve School of Medicine, Case Western Reserve University, Cleveland, OH, USA.
³ Veracyte, Inc, South San Francisco, CA, USA.
⁴ Department of Urology, Weil Cornell Medicine, New York, NY, USA.
⁵ Information Management Systems, Inc, Calverton, MD, USA.
⁶ Iowa Cancer Registry, The University of Iowa, IA, USA.
⁷ Public Health Institute, Cancer Registry of Greater California, Sacramento, CA, USA.
⁸ Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
⁹ Department of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.
¹⁰ Cancer Research Informatics Shared Resource Facility, Markey Cancer Center, Kentucky Cancer Registry, University of Kentucky, Lexington, KY, USA.
¹¹ Massachusetts Cancer Registry, Boston, MA, USA.
¹² Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
¹³ Connecticut Tumor Registry, Connecticut Department of Public Health, Hartford, CT, USA.
¹⁴ University of Hawaii Cancer Center, HI, USA.
¹⁵ Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
¹⁶ Cancer Data Registry of Idaho, Boise, ID, USA.
¹⁷ School of Public Health Epidemiology & Biostatistics, University at Albany, State University of New York, NY, USA.
¹⁸ Division of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.
¹⁹ Rollins School of Public Health, Emory University, Atlanta, GA, USA.
²⁰ Department of Internal Medicine, University of NM, Albuquerque, NM, USA.
²¹ Department of Epidemiology, School of Medicine, Louisiana State University, New Orleans, LA, USA.
²² Department of Radiation Oncology, University of Miami, Miami, FL, USA.
²³ Department of Urology, Northwestern University, Chicago, IL, USA.
²⁴ Surveillance Research Program, National Cancer Institute, Bethesda, MD, USA.

PMID: 37525535
PMCID: PMC10505256
DOI: 10.1093/jncics/pkad052

Use of the Decipher genomic classifier among men with prostate cancer in the United States

Nicholas G Zaorsky et al. JNCI Cancer Spectr. 2023.

. 2023 Aug 31;7(5):pkad052.

doi: 10.1093/jncics/pkad052.

Authors

Affiliations

¹ Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Cleveland, OH, USA.
² Department of Population and Quantitative Health Sciences, Case Western Reserve School of Medicine, Case Western Reserve University, Cleveland, OH, USA.
³ Veracyte, Inc, South San Francisco, CA, USA.
⁴ Department of Urology, Weil Cornell Medicine, New York, NY, USA.
⁵ Information Management Systems, Inc, Calverton, MD, USA.
⁶ Iowa Cancer Registry, The University of Iowa, IA, USA.
⁷ Public Health Institute, Cancer Registry of Greater California, Sacramento, CA, USA.
⁸ Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
⁹ Department of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.
¹⁰ Cancer Research Informatics Shared Resource Facility, Markey Cancer Center, Kentucky Cancer Registry, University of Kentucky, Lexington, KY, USA.
¹¹ Massachusetts Cancer Registry, Boston, MA, USA.
¹² Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
¹³ Connecticut Tumor Registry, Connecticut Department of Public Health, Hartford, CT, USA.
¹⁴ University of Hawaii Cancer Center, HI, USA.
¹⁵ Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
¹⁶ Cancer Data Registry of Idaho, Boise, ID, USA.
¹⁷ School of Public Health Epidemiology & Biostatistics, University at Albany, State University of New York, NY, USA.
¹⁸ Division of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.
¹⁹ Rollins School of Public Health, Emory University, Atlanta, GA, USA.
²⁰ Department of Internal Medicine, University of NM, Albuquerque, NM, USA.
²¹ Department of Epidemiology, School of Medicine, Louisiana State University, New Orleans, LA, USA.
²² Department of Radiation Oncology, University of Miami, Miami, FL, USA.
²³ Department of Urology, Northwestern University, Chicago, IL, USA.
²⁴ Surveillance Research Program, National Cancer Institute, Bethesda, MD, USA.

PMID: 37525535
PMCID: PMC10505256
DOI: 10.1093/jncics/pkad052

Abstract

Background: Management of localized or recurrent prostate cancer since the 1990s has been based on risk stratification using clinicopathological variables, including Gleason score, T stage (based on digital rectal exam), and prostate-specific antigen (PSA). In this study a novel prognostic test, the Decipher Prostate Genomic Classifier (GC), was used to stratify risk of prostate cancer progression in a US national database of men with prostate cancer.

Methods: Records of prostate cancer cases from participating SEER (Surveillance, Epidemiology, and End Results) program registries, diagnosed during the period from 2010 through 2018, were linked to records of testing with the GC prognostic test. Multivariable analysis was used to quantify the association between GC scores or risk groups and use of definitive local therapy after diagnosis in the GC biopsy-tested cohort and postoperative radiotherapy in the GC-tested cohort as well as adverse pathological findings after prostatectomy.

Results: A total of 572 545 patients were included in the analysis, of whom 8927 patients underwent GC testing. GC biopsy-tested patients were more likely to undergo active active surveillance or watchful waiting than untested patients (odds ratio [OR] =2.21, 95% confidence interval [CI] = 2.04 to 2.38, P < .001). The highest use of active surveillance or watchful waiting was for patients with a low-risk GC classification (41%) compared with those with an intermediate- (27%) or high-risk (11%) GC classification (P < .001). Among National Comprehensive Cancer Network patients with low and favorable-intermediate risk, higher GC risk class was associated with greater use of local therapy (OR = 4.79, 95% CI = 3.51 to 6.55, P < .001). Within this subset of patients who were subsequently treated with prostatectomy, high GC risk was associated with harboring adverse pathological findings (OR = 2.94, 95% CI = 1.38 to 6.27, P = .005). Use of radiation after prostatectomy was statistically significantly associated with higher GC risk groups (OR = 2.69, 95% CI = 1.89 to 3.84).

Conclusions: There is a strong association between use of the biopsy GC test and likelihood of conservative management. Higher genomic classifier scores are associated with higher rates of adverse pathology at time of surgery and greater use of postoperative radiotherapy.In this study the Decipher Prostate Genomic Classifier (GC) was used to analyze a US national database of men with prostate cancer. Use of the GC was associated with conservative management (ie, active surveillance). Among men who had high-risk GC scores and then had surgery, there was a 3-fold higher chance of having worrisome findings in surgical specimens.

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Conflict of interest statement

James Proudfoot, Yang Liu, Xin Zhao, and Elai Davicioni are employees of Veracyte, Inc the makers of the Decipher test. Ashley Ross reports consulting fees as a medical advisor to Veracyte, Inc. The remaining co-authors declare no conflicts of interest.

Figures

**Figure 1.**
CONSORT diagram. SEER = Surveillance, Epidemiology, and End Results.

**Figure 2.**
Test-ordering volume over time. GC = genomic classifier.

**Figure 3.**
Forest plot of GC score distributions by clinical and pathological characteristics for GC biopsy and GC prostatectomy scores, respectively. Data are presented as median (first quartile [Q1], third quartile [Q3]), with low, intermediate, and high regions defined by previously locked commercial cut points. GC = genomic classifier.

**Figure 4.**
Rates of (A) active surveillance/watchful waiting among NCCN low and favorable-intermediate risk men and (B) radiation after radical prostatectomy among men with adverse pathological features (pT3/4, LN+, or pGG 4 to 5) in the GC untested and GC biopsy (A) and prostatectomy (B) tested cohorts. Vertical bars indicate 95% confidence intervals. GC = genomic classifier; LN+ = lymph-node positive; NCCN = National Comprehensive Cancer Network; pGG = pathological grade group.

See this image and copyright information in PMC

References

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Use of the Decipher genomic classifier among men with prostate cancer in the United States

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Use of the Decipher genomic classifier among men with prostate cancer in the United States

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Conflict of interest statement

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