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PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs
Future Research Needs Papers, No. 24
Investigators: Steven I Gutman, MD, MBA, Denise M Oliansky, MA, MLIS, Suzanne Belinson, PhD, MPH, and Naomi Aronson, PhD.
Author Information and AffiliationsStructured Abstract
Background:
Cancer of the prostate is the second most common cancer and the second leading cause of cancer deaths in men in the United States. Screening to detect disease using the total prostate-specific antigen test is a common but controversial practice. The prostate cancer antigen-3 gene (PCA3) has recently been found to be overexpressed in prostate cancers, is measurable in urine, and may be a useful biomarker for improving the results of cancer screening programs.
Objectives:
The objective of this report was to generate prioritized topics for future research on PCA3, building on evidence gaps identified in a prior draft Comparative Effectiveness Review (CER) and following an explicit stakeholder-driven nomination and prioritization process.
Data sources:
Data sources included a draft CER on PCA3, a comprehensive literature search, and input from members of the Stakeholder Panel.
Methods:
Building on evidence gaps identified in a draft CER on PCA3, a preliminary list of future research needs was developed. This was reviewed and refined using input from a diverse group of stakeholders with a common interest in prostate cancer. Stakeholders were asked to prioritize topics using the following elements: current importance, potential for significant health impact, incremental value, and feasibility. An iterative process, including the use of teleconferences and SurveyMonkey®, an online survey tool, was used to prioritize research needs and questions.
Results:
Three high-priority research needs were identified, as well as seven research questions. These included the need for information on the comparative performance of PCA3 versus currently used prostate cancer biomarkers, studies on how PCA3 affects biopsy decisionmaking, and studies on how PCA3 affects long-term health outcomes.
Conclusions:
A variety of future research needs were identified and prioritized to inform future study of PCA3. This research should help to determine the role PCA3 should play in the diagnosis and management of patients with prostate cancer.
Contents
- Preface
- Acknowledgments
- Stakeholder Panel
- Executive Summary
- Background
- Methods
- Results
- Discussion
- References
- Appendix A Conclusions From Draft Comparative Effectiveness Review of PCA3 for Detection and Treatment of Prostate Cancer
- Appendix B Methodological and Statistical Gaps in Knowledge About PCA3 Testing
- Appendix C Search Strategy for Recently Published and Ongoing Studies on PCA3 Testing
- Appendix D Literature Relevant to PCA3 Research Needs
- Appendix E SurveyMonkey® Form for Prioritizing PCA3 Research Needs
- Appendix F Results From PCA3 Research Needs Prioritization Survey
- Appendix G SurveyMonkey® Form for Prioritizing PCA3 Research Questions
- Appendix H Results From PCA3 Research Questions Prioritization Survey
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10058-I, Prepared by: Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center, Chicago, IL
Suggested citation:
Gutman SI, Oliansky DM, Belinson S, Aronson N. PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs. Future Research Needs Paper No. 24. (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-2007-10058-I.) AHRQ Publication No. 13-EHC005-EF. Rockville, MD: Agency for Healthcare Research and Quality. April 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10058-I). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care researchers and funders of research make well-informed decisions in designing and funding research and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of scientific judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical research and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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