Figure A depicts the framework for KQ1 with the patient population of male patients with an elevated PSA level and/or abnormal digital rectal exam (DRE). This figure depicts the comparative effectiveness of using PCA3 testing versus other tests (e.g., PSA) for intermediate outcomes and long-term health outcomes. Direct evidence of testing impact on health outcomes (e.g. reduced mortality/morbidity, quality of life) is shown by Link A. In the indirect chain of evidence, Link B addresses the diagnostic accuracy (clinical validity) of the PCA3 test and designated comparators. Link C addresses the impact of test results on the decision to proceed to the initial prostate biopsy, which, in turn, impacts the intermediate outcomes (Link D) and may affect health outcomes (Link E). Intermediate outcomes may have an association with long term health outcomes (Link F). Link G on the on the left focuses on adverse events/personal harms related to biopsy left addresses potential personal and clinical harms related to the effect of testing on the decision about biopsy, and on the right focuses on adverse events/personal harms related to biopsy. The framework for KQ2 is essentially the same, except the population is male patients with elevated PSA and/or DRE, as well as one or more previous negative prostate biopsies. Link C in this case addresses the impact of test results on the decision to proceed to repeat prostate biopsy.

Figure AFuture research needs for PCA3 testing: analytic framework for PCA3 as a diagnostic indicator for biopsy or rebiopsy in patients with elevated tPSA and/or abnormal digital rectal examination (Key Questions 1 and 2)

Abbreviations: PCA3 = prostate cancer antigen 3 gene; PSA = prostate-specific antigen; tPSA = total prostate-specific antigen

a Patients may be evaluated for initial biopsy after one or more negatives.

Note: For link B, PCA3 shows increased diagnostic accuracy compared with tPSA (low strength of evidence); for all other links (comparators and outcomes), strength of evidence is insufficient.

From: Executive Summary

Cover of PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs
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].
Future Research Needs Papers, No. 24.
Gutman SI, Oliansky DM, Belinson S, et al.
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