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|Issue 211||May 2023|
The report is a product of the VA/HSR&D Evidence Synthesis Program.
Prognostic Value of Genomic Classifier Testing for Prostate Cancer: A Systematic Review
Takeaway: Genomic classifier tests for prostate cancer may offer some additional prognostic benefit over existing clinically-based risk schemas and may be helpful when management decisions are uncertain. However, definitive evidence of the prognostic ability of these tests is still needed from current management-era data.
Prostate cancer is the most common malignancy in men, with an estimated 268,490 new cases in the United States in 2022, and 12,500 new diagnoses annually within the VA healthcare system. A major challenge for prostate cancer management is identifying patients who would benefit from treatment and tailoring the intensity of that treatment to personalized risk assessments. Individualized prognosis – beyond clinically-based risk stratification schemas – could inform patient-physician decision-making, reduce unnecessary overtreatment, and improve patient outcomes. A relatively recent advancement in prostate cancer risk stratification is the development of commercially available, tissue-based genomic classifiers.
The VA Evidence Synthesis Program (ESP) Center located at the Durham VA Medical Center conducted a systematic review to evaluate the impact of genomic classifier tests on risk reclassification, treatment recommendations, and key clinical outcomes among patients with prostate cancer at the time of diagnosis and after definitive initial treatment. The genomic classifier tests studied included: Decipher, Oncotype DX GPS (now named Genomic Prostate Score but referred to in this report as Oncotype), and Prolaris. Investigators searched MEDLINE (via Ovid), Embase (via Elsevier), and Web of Science (via Clarivate) databases from 2010 to the present. From more than 1,500 potentially relevant articles, 59 articles (55 unique studies) were included in this review. The 55 studies consisted of 1 randomized controlled trial, 1 secondary analysis of a randomized controlled trial, 1 individual patient-level meta-analysis, 2 case-control studies, and 50 observational cohorts (8 prospective, 42 retrospective). Of the 55 studies, 4 were conducted solely within VA and 7 additional studies included a VA cohort.
Summary of Findings
Overall, investigators found that three genomic classifier tests (Decipher, Oncotype DX GPS, and Prolaris) seemed to provide modest additional prognostic information over existing clinical risk prediction schemas with respect to biochemical recurrence, development of metastatic disease, and prostate-cancer-specific mortality. More specifically:
Significant limitations of the existing literature include that it was largely drawn from patients diagnosed and treated prior to the current era of prostate cancer management (prior to 2000). Investigators were unable to compare across genomic test types, as no identified literature provided a direct comparison. In addition, no study reported harms due to genomic classifier testing.
Implications for VA
Across all included studies, the patient populations were similar to VA patients based on patient characteristics (e.g., age, comorbidities). Several of the identified studies included VA-sourced data. These findings are expected to be generalizable to the VA clinical setting.
To strengthen the body of evidence outlined in this report, investigators suggest the following considerations for future research.
Boyer MJ, Carpenter D, Gingrich JR, et al. Prognostic Value of Genomic Classifier Testing for Prostate Cancer: A Systematic Review. Washington, DC: Evidence Synthesis Program, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-010; 2023.
To view the full report, go to https://vaww.hsrd.research.va.gov/publications/esp/genomics-master.cfm (Intranet only).
ESP is currently soliciting review topics from the broader VA community. Nominations will be accepted electronically using the online Topic Submission Form. If your topic is selected for a synthesis, you will be contacted by an ESP Center to refine the questions and determine a timeline for the report.
This Management e-Brief is provided to inform you about recent HSR&D findings that may be of interest. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. If you have any questions or comments about this Brief, please email CIDER. The Center for Information Dissemination and Education Resources (CIDER) is a VA HSR&D Resource Center charged with disseminating important HSR&D findings and information to policy makers, managers, clinicians, and researchers working to improve the health and care of Veterans.
This report is a product of VA/HSR&D's Evidence Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers –; and to disseminate these reports throughout VA.
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