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PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 98 [Internet].


Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC005-EF.
AHRQ Future Research Needs Papers.

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Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center



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.


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 included a draft CER on PCA3, a comprehensive literature search, and input from members of the Stakeholder Panel.


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.


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.


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.

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