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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 Veterans Health Administration (VHA). 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. Risk stratification traditionally has been based on readily available clinical features; however, multiple options exist for treatment, and there is variability in patient outcomes not otherwise explained by currently recognized risk factors. Individualized prognosis beyond clinically based risk stratification schemas could inform patient-physician decisionmaking, 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. This systematic review addresses the impact of 3 commercial genomic classifier tests—Decipher, Oncotype DX GPS (now named Genomic Prostate Score but referred to in this report as Oncotype), and Prolaris—on risk classification, treatment choice and harms, and the prognostic ability of these tests beyond the clinical features of patients diagnosed with or treated for localized prostate cancer. (See Appendix A for guidelines for the 3 tests.)
Contents
- PREFACE
- ACKNOWLEDGMENTS
- ABBREVIATIONS TABLE
- EXECUTIVE SUMMARY
- INTRODUCTION
- METHODS
- RESULTS
- LITERATURE FLOW
- LITERATURE OVERVIEW
- KEY QUESTION 1: AMONG INDIVIDUALS WITH LOCALIZED PROSTATE CANCER WHO ARE CONSIDERING FIRST-LINE DEFINITIVE TREATMENT, DOES THE ADDITION OF A TISSUE-BASED GENOMIC TEST TO EXISTING CLINICAL RISK MODELS IMPACT RISK CLASSIFICATION?
- KEY QUESTION 2: DOES TISSUE-BASED GENOMIC TESTING IMPACT THE CHOICE OF TREATMENT INTENSITY OR HARMS AMONG A) INDIVIDUALS WITH LOCALIZED PROSTATE CANCER BEFORE FIRST-LINE DEFINITIVE TREATMENT OR B) INDIVIDUALS WHO HAVE UNDERGONE RADICAL PROSTATECTOMY?
- KEY QUESTION 3: AMONG PATIENTS WITH LOCALIZED PROSTATE CANCER, WHAT IS THE PROGNOSTIC EFFECT OF TISSUE-BASED GENOMIC TESTS AFTER ADJUSTING FOR EXISTING PROGNOSTIC CLINICAL FEATURES ON KEY CLINICAL OUTCOMES (eg, BIOCHEMICAL RECURRENCE-FREE SURVIVAL, METASTASES-FREE SURVIVAL) FOLLOWING DEFINITIVE TREATMENT?
- DISCUSSION
- REFERENCES
- APPENDIX A. GENOMIC CLASSIFIER GUIDELINE TABLES
- APPENDIX B. SEARCH STRATEGIES
- APPENDIX C. CONCEPTUAL FRAMEWORK
- APPENDIX D. EXCLUDED STUDIES
- APPENDIX E. STUDY CHARACTERISTICS
- APPENDIX F. PEER REVIEW DISPOSITION
- APPENDIX G. ONGOING STUDIES
Suggested citation:
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.
This report was prepared by the Evidence Synthesis Program Center located at the Durham VA Medical Center, directed by Jennifer M. Gierisch, PhD, MPH, and Karen M. Goldstein, MD, MSPH, and funded by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development.
The findings and conclusions in this document are those of the author(s) who are responsible for its contents and do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report.
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