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<IndexPatientGuideline ID="x22678" Name="Guideline Statement 3" IsComponent="true" Changed="20260406T15:40:11" Created="20260406T15:39:12" Published="20260416T10:28:39" SiteBaseUrl="https://www.auanet.org" Locale="" XPowerPath="/Home/Guidelines &amp; Quality/Guidelines/Clinical Guidelines/Clinically Localized Prostate Cancer/Risk Assessment/Guideline Statement 3">
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  <Header type="string" UID="faf9fd2842b549d09e761cd943c2be20" label="Header" readonly="false" hidden="false" required="false" indexable="false" CIID="">Guideline Statement 3</Header>
  <BodyCopy type="xhtml" UID="41a2d8598c364193bbfe9ad86d7bcd3c" label="Body Copy" readonly="false" hidden="false" required="false" indexable="false" Height="" CIID="">&lt;p&gt;&lt;strong&gt; &lt;/strong&gt;&lt;strong&gt;Clinicians should not routinely use tissue-based genomic biomarkers for risk stratification or clinical decision-making. &lt;em&gt;(Moderate Recommendation; Evidence Level: Grade B)&lt;/em&gt;&lt;/strong&gt;&lt;/p&gt;</BodyCopy>
  <DiscussionLinkName type="string" UID="b364402056154f78b38cd8d663eaf3ba" label="Discussion Link Name" readonly="false" hidden="false" required="false" indexable="false" CIID="">Discussion</DiscussionLinkName>
  <DiscussionTitle type="string" UID="ceedafe4ad314b5d8d3225bc0083b81c" label="Discussion Title" readonly="false" hidden="false" required="false" indexable="false" CIID="">Discussion</DiscussionTitle>
  <DiscussionBody type="xhtml" UID="9bbbac02721d4eefba59c63ee7ff9007" label="Discussion Body" readonly="false" hidden="false" required="false" indexable="false" Height="" CIID="">&lt;p&gt;Regarding tissue-based genomic biomarkers, several currently available commercial tests, including Prolaris, Oncotype Dx, and Decipher, variously offer prediction of adverse pathology as well as the risks of biochemical recurrence, metastasis, and prostate cancer death. However, most of the reported studies to date that evaluated the prognostic ability of these genomic tests did not meet inclusion criteria for the systematic review as the studies used surgical (i.e., prostatectomy) rather than biopsy specimens. Notably, two studies using biopsy data have shown that a cell cycle progression panel (Prolaris) score was associated with the risks of biochemical recurrence, metastatic disease, and prostate cancer death; however, only one of those studies met inclusion criteria for the systematic review.&lt;sup&gt;19, 20, 56&lt;/sup&gt; The Oncotype Dx assay has been validated on needle biopsy tissue and found to be associated with adverse pathology, biochemical recurrence, metastasis, and prostate cancer death; again, however, the studies did not meet inclusion criteria for the systematic review.&lt;sup&gt;57-60&lt;/sup&gt;&lt;sup&gt; &lt;/sup&gt;Meanwhile, a multi-institutional evaluation of Decipher Biopsy testing found that a high-risk Decipher score was associated with conversion from active surveillance to definitive treatment.&lt;sup&gt;48&lt;/sup&gt;&lt;/p&gt;
&lt;p&gt;Thus, based on the level of existing data, the Panel concluded that clinicians should not routinely use tissue-based genomic biomarkers for risk stratification or clinical decision-making; however, clinicians may use such tests selectively when added risk stratification may alter SDM. These recommendations are largely consistent with ASCO Guidelines as well.&lt;sup&gt;61&lt;/sup&gt; Examples of patients for whom tissue-based genomic markers may help clarify risk include patients with high-volume (multiple involved cores) Gleason score 6 cancer as well as select men with favorable intermediate-risk prostate cancer who are interested in active surveillance. Examples of patients for whom tissue-based genomic markers are not recommended including most men with low-volume (few involved cores) Gleason score 6 cancer and men with favorable intermediate-risk prostate cancer who are interested in treatment.&lt;/p&gt;
&lt;p&gt;The Panel recognizes that this is an active area of research. Most notably, prospective validation of the predictive capacity of genomic classifiers (GC) in localized disease will be important to support widespread use for treatment selection. Additional discussion on GCs may be found in Future Directions.&lt;/p&gt;</DiscussionBody>
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