Validation of the Decipher Test for predicting adverse pathology in candidates for prostate cancer active surveillance

• Published in: Prostate cancer and prostatic diseases Vol. 22; no. 3; pp. 399 - 405
• Main Authors: Kim, Hyung L., Li, Ping, Huang, Huei-Chung, Deheshi, Samineh, Marti, Tara, Knudsen, Beatrice, Abou-Ouf, Hatem, Alam, Ridwan, Lotan, Tamara L., Lam, Lucia L. C., du Plessis, Marguerite, Davicioni, Elai, Fleshner, Neil, Lane, Brian R., Ross, Ashley E., Davis, John W., Mohler, James L., Trock, Bruce J., Klein, Eric A., Tosoian, Jeffrey J., Hyndman, M. Eric, Bismar, Tarek A.
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.09.2019; Nature Publishing Group
• Subjects: 38/39; 45/61; 45/90; 692/53/2422; 692/699/67/589/466; Aged; Biomarkers, Tumor - genetics; Biomedical and Life Sciences; Biomedicine; Biopsy; Cancer Research; Care and treatment; Confidence intervals; Diagnostic systems; Disease Progression; Feasibility Studies; Gene Expression Profiling - methods; Genetic screening; Health risks; Humans; Life span; Lymph nodes; Male; Metastases; Methods; Middle Aged; Oligonucleotide Array Sequence Analysis; Pathology; Patient Selection; Prognosis; Prospective Studies; Prostate - pathology; Prostate - surgery; Prostate cancer; Prostatectomy; Prostatic Neoplasms - genetics; Prostatic Neoplasms - pathology; Prostatic Neoplasms - surgery; Retrospective Studies; Risk assessment; Risk Assessment - methods; Surveillance; Watchful Waiting; Watchful waiting (Medical care); Canada; United States
• ISSN: 1365-7852; 1476-5608
• DOI: 10.1038/s41391-018-0101-6

Abstact Background Many men diagnosed with prostate cancer are active surveillance (AS) candidates. However, AS may be associated with increased risk of disease progression and metastasis due to delayed therapy. Genomic classifiers, e.g., Decipher, may allow better risk-stratify newly diagnosed prostate cancers for AS. Methods Decipher was initially assessed in a prospective cohort of prostatectomies to explore the correlation with clinically meaningful biologic characteristics and then assessed in diagnostic biopsies from a retrospective multicenter cohort of 266 men with National Comprehensive Cancer Network (NCCN) very low/low and favorable-intermediate risk prostate cancer. Decipher and Cancer of the Prostate Risk Assessment (CAPRA) were compared as predictors of adverse pathology (AP) for which there is universal agreement that patients with long life-expectancy are not suitable candidates for AS (primary pattern 4 or 5, advanced local stage [pT3b or greater] or lymph node involvement). Results Decipher from prostatectomies was significantly associated with adverse pathologic features ( p -values < 0.001). Decipher from the 266 diagnostic biopsies (64.7% NCCN-very-low/low and 35.3% favorable-intermediate) was an independent predictor of AP (odds ratio 1.29 per 10% increase, 95% confidence interval [CI] 1.03–1.61, p -value 0.025) when adjusting for CAPRA. CAPRA area under curve (AUC) was 0.57, (95% CI 0.47–0.68). Adding Decipher to CAPRA increased the AUC to 0.65 (95% CI 0.58–0.70). NPV, which determines the degree of confidence in the absence of AP for patients, was 91% (95% CI 87–94%) and 96% (95% CI 90–99%) for Decipher thresholds of 0.45 and 0.2, respectively. Using a threshold of 0.2, Decipher was a significant predictor of AP when adjusting for CAPRA ( p -value 0.016). Conclusion Decipher can be applied to prostate biopsies from NCCN-very-low/low and favorable-intermediate risk patients to predict absence of adverse pathologic features. These patients are predicted to be good candidates for active surveillance.