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<IndexPatientGuideline ID="x22676" Name="Guideline Statement 1" IsComponent="true" Changed="20260414T17:43:49" Created="20260406T15:37:03" 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 1">
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  <Header type="string" UID="faf9fd2842b549d09e761cd943c2be20" label="Header" readonly="false" hidden="false" required="false" indexable="false" CIID="">Guideline Statement 1</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 use clinical T stage, serum PSA, Grade Group (Gleason score), and tumor volume on biopsy to risk stratify patients with newly diagnosed prostate cancer. &lt;em&gt;(Strong Recommendation; Evidence Level: Grade A)&lt;/em&gt;&lt;/strong&gt;&lt;/p&gt;</BodyCopy>
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  <DiscussionBody type="xhtml" UID="9bbbac02721d4eefba59c63ee7ff9007" label="Discussion Body" readonly="false" hidden="false" required="false" indexable="false" Height="" CIID="">&lt;p&gt;The risk of disease progression and adverse oncologic outcomes of prostate cancer varies widely based on clinicopathologic characteristics. Disease risk stratification is vital at the outset of patient counseling to align the aggressiveness of management to the severity of disease. Several risk stratification systems have been described and have been variously utilized, including risk groups, risk scores, and nomograms.&lt;sup&gt;10-14&lt;/sup&gt; The Panel did conduct a systematic review of the literature to verify that the individual features of the risk groups remain associated with likelihood of adverse pathologic findings, biochemical recurrence, metastases, and death, and to evaluate whether mature data exist to support inclusion of additional parameters to enhance risk stratification. In total, 30 studies on prognostic factors in localized prostate cancer met inclusion criteria.&lt;sup&gt;12, 17-48&lt;/sup&gt; Sample sizes ranged from 1,062 to 19,684 patients.&lt;/p&gt;
&lt;p&gt;Nineteen cohort studies evaluated baseline PSA level as a prognostic factor in patients with clinically localized prostate cancer who underwent curative treatment (typically radical prostatectomy or radiation therapy). Higher PSA level was associated with increased risks of biochemical recurrence,&lt;sup&gt;12, 18, 21, 22, 24, 26-30, 32, 35, 37, 40, 44, 45, 47&lt;/sup&gt; prostate cancer-specific mortality,&lt;sup&gt;18&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;26&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;32&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;35&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;47&lt;/sup&gt;&lt;sup&gt; &lt;/sup&gt;and all-cause mortality.&lt;sup&gt;32&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;35&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;40&lt;/sup&gt; Similarly, a separate series evaluated baseline PSA level as a prognostic factor in patients with clinically localized prostate cancer who did not undergo curative treatment and noted an association between higher PSA level and increased risk of prostate cancer mortality.&lt;sup&gt;24&lt;/sup&gt; Overall, PSA level was deemed to be an important risk factor that should be assessed, documented, and used to categorize patient risk.&lt;/p&gt;
&lt;p&gt;Clinical T-stage is determined by DRE and is defined according to the American Joint Committee on Cancer (AJCC) system.&lt;sup&gt;16&lt;/sup&gt;&lt;sup&gt;, &lt;/sup&gt;&lt;sup&gt;49&lt;/sup&gt; Higher clinical T-stage was found to be associated with increased risk of biochemical recurrence,&lt;sup&gt;18, 21, 23, 33, 36, 38, 41, 46&lt;/sup&gt; prostate cancer-specific mortality,&lt;sup&gt;18, 26, 35, 47&lt;/sup&gt; and all-cause mortality,&lt;sup&gt;32, 35&lt;/sup&gt; including among patients who did not undergo definitive treatment.&lt;sup&gt;17, 24&lt;/sup&gt; Thus, clinical T-stage should be ascertained by DRE, documented in the chart, and used to categorize patient risk. Of note, prostate imaging (ultrasound or MRI) is not at this time used to assign clinical T-stage for risk classification. Nevertheless, the Panel acknowledges that imaging (e.g., MRI) findings may provide additional information regarding local tumor extent,&lt;sup&gt;50&lt;/sup&gt; and may be utilized in disease prognostication/treatment planning.&amp;nbsp;&lt;/p&gt;
&lt;p&gt;Cancer grade on biopsy is assigned using the World Health Organization/ International Society of Urologic Pathologists (WHO/ISUP) Grade Group system or the older Gleason score system. ISUP recommends that Gleason scores 6, 3 + 4 = 7, 4 + 3 = 7, 8 and 9-10, be reported as ISUP grades 1-5, respectively.&lt;sup&gt;51&lt;/sup&gt; Fourteen cohort studies evaluated baseline Gleason score as a prognostic factor in patients with clinically localized prostate cancer who underwent curative treatment. Higher Gleason score was associated with increased risks of biochemical recurrence,&lt;sup&gt;21, 23, 33, 35, 37, 38, 41, 46&lt;/sup&gt; metastatic disease,&lt;sup&gt;39, 42, 43&lt;/sup&gt; prostate cancer-specific mortality,&lt;sup&gt;26, 32, 35, 42, 43, 47&lt;/sup&gt; and all-cause mortality.&lt;sup&gt;32, 35, 40&lt;/sup&gt; Gleason score was also a strong predictor of prostate cancer mortality in patients who did not undergo curative treatment.&lt;sup&gt;17, 24&lt;/sup&gt; As such, Grade Group is included in risk assessment. The Panel acknowledges that certain histologic features, such as intraductal and cribriform patterns, have likewise been associated with worse prognosis.&lt;sup&gt;52-54&lt;/sup&gt; Such features, when available, should be considered when counseling an individual patient.&lt;/p&gt;
&lt;p&gt;Of note, the Panel did not include PSA density (serum PSA [ng/mL] divided by imaging measured prostate volume [cc]) in the systematic literature review. However, an ad-hoc literature review demonstrated that a PSA density &amp;ge; 0.15 ng/mL/cc has been associated with the risk of upgrading on subsequent biopsy among patients on active surveillance.&lt;sup&gt;55&lt;/sup&gt; As such, the Panel believes that PSA density remains an important component of disease risk assessment. Of note, the Panel does recognize the continuous nature of risk associated with the spectrum of PSA density values and cautions against use of threshold values in isolation for management decision-making.&lt;/p&gt;</DiscussionBody>
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