Does PCA3 Testing for the Diagnosis and Management of Prostate Cancer improve patient health outcomes?

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It has been suggested that PCA3 Testing in men may inform when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination), and in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan that would improve clinical outcomes. EWG found no direct evidence to support this possibility, so this review sought indirect evidence aimed at documenting the extent to which PCA3 Testing alters decisions when to rebiopsy previously biopsy-negative patients for prostate cancer; to conduct initial biopsies in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination); or in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.

EGAPP Recommendation Statement: The Evaluation of Genomic Applications in Practice and Prevention Working Group found insufficient evidence to recommend prostate cancer antigen 3 testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination). The Evaluation of Genomic Applications in Practice and Prevention Working Group found insufficient evidence to recommend prostate cancer antigen 3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.

Based on the available evidence, the overall certainty of clinical validity to predict the diagnosis of prostate cancer using prostate cancer antigen 3 is deemed “low.” The Evaluation of Genomic Applications in Practice and Prevention Working Group discourages clinical use for diagnosis unless further evidence supports improved clinical validity.

Based on the available evidence, the overall certainty of net health benefit is deemed “low.” The Evaluation of Genomic Applications in Practice and Prevention Working Group discourages clinical use unless further evidence supports improved clinical outcomes.

EGAPP Recommendation (September 2013)

Summary Article: Pending

Evidence Report: PCA3 Testing for the Diagnosis and Management of Prostate Cancer (PDF 1.88 MB) (April 2013), Blue Cross Blue Shield Technical Evidence Center, AHRQ Evidence-based Practice Center

CDC Summary of EGAPP Recommendation: Pending

Key Questions:

Question 1: In patients with elevated PSA and/or an abnormal digital rectal examination who are candidates for initial prostate biopsy, what is the comparative effectiveness of PCA3 testing as a replacement for, or supplement to, standard tests, including diagnostic accuracy (clinical validity) for prostate cancer, intermediate outcomes (e.g., improved decision making about biopsy), and long-term health outcomes (clinical utility), including mortality/morbidity, quality of life, and potential harms?
Question 2: In patients with elevated PSA and/or an abnormal digital rectal examination who are candidates for repeat prostate biopsy, what is the comparative effectiveness of PCA3 testing as a replacement for, or supplement to, standard tests, including diagnostic accuracy (clinical validity) for prostate cancer, intermediate outcomes (e.g., improved decisionmaking about biopsy), and long-term health outcomes (clinical utility), including mortality/morbidity, quality of life, and potential harms?
Question 3: In patients with a positive biopsy for prostate cancer who are being evaluated to distinguish between insignificant/indolent and aggressive disease, what is the effectiveness of using PCA3 testing alone, or in combination with the standard prognostic workup (e.g., tumor volume, Gleason score, clinical staging) or monitoring tests (e.g., PSA, PSA velocity), with regard to diagnostic accuracy (clinical validity) for aggressive (high-risk) prostate cancer, intermediate outcomes (e.g., improved decisionmaking about prognosis and triage for active surveillance and/or aggressive treatment), and long-term health outcomes (clinical utility), including mortality/morbidity, quality of life, and potential harms?

Why EGAPP Selected this Topic for Review:

Key Criteria: Opportunity to use evidence review from AHRQ’s Effective Health Care Program

Other Considerations: EGAPP methods challenged by limited input in development of key questions and defined method of review.