Artitaya Lophatananon, Alexander Light, Nicholas Burns-Cox, Angus Maccormick, Joseph John, Vanessa Otti, John McGrath, Pete Archer, Jonathan Anning, Stuart McCracken, Toby Page, Ken Muir, Vincent J Gnanapragasam
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Here, we tested whether better contemporary pathways and biopsy methods had improved the predictive utility value of PSA referral thresholds.</p><p><strong>Methods: </strong>PSA referral thresholds, age-referenced ranges and PSA density (PSAd) were assessed for positive predictive value (PPV) in detection of clinically significant prostate cancer (csPCa - histological ⩾ Grade Group 2). Data were analysed from men referred to three diagnostics centres who used multi-parametric magnetic resonance imaging (mpMRI)-guided prostate biopsies for disease characterisation. Findings were validated in a separate multicentre cohort. Results: Data from 2767 men were included in this study. The median age, PSA and PSAd were 66.4 years, 7.3 ng/mL and 0.1 ng/mL<sup>2</sup>, respectively. Biopsy detected csPCa was found in 38.7%. The overall area under the curve (AUC) for PSA was 0.68 which is similar to historical performance. A PSA threshold of ⩾ 3 ng/mL had a PPV of 40.3%, but this was age dependent (PPV: 24.8%, 32.7% and 56.8% in men 50-59 years, 60-69 years and ⩾ 70 years, respectively). Different PSA cut-offs and age-reference ranges failed to demonstrate better performance. PSAd demonstrated improved AUC (0.78 vs 0.68, <i>p</i> < 0.0001) and improved PPV compared to PSA. A PSAd of ⩾ 0.10 had a PPV of 48.2% and similar negative predictive value (NPV) to PSA ⩾ 3 ng/mL and out-performed PSA age-reference ranges. This improved performance was recapitulated in a separate multi-centre cohort (<i>n</i> = 541).</p><p><strong>Conclusion: </strong>The introduction of MRI-based image-guided biopsy pathways does not appear to have altered PSA diagnostic test characteristics to positively detect csPCa. 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The overall area under the curve (AUC) for PSA was 0.68 which is similar to historical performance. A PSA threshold of ⩾ 3 ng/mL had a PPV of 40.3%, but this was age dependent (PPV: 24.8%, 32.7% and 56.8% in men 50-59 years, 60-69 years and ⩾ 70 years, respectively). Different PSA cut-offs and age-reference ranges failed to demonstrate better performance. PSAd demonstrated improved AUC (0.78 vs 0.68, <i>p</i> < 0.0001) and improved PPV compared to PSA. A PSAd of ⩾ 0.10 had a PPV of 48.2% and similar negative predictive value (NPV) to PSA ⩾ 3 ng/mL and out-performed PSA age-reference ranges. This improved performance was recapitulated in a separate multi-centre cohort (<i>n</i> = 541).</p><p><strong>Conclusion: </strong>The introduction of MRI-based image-guided biopsy pathways does not appear to have altered PSA diagnostic test characteristics to positively detect csPCa. 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引用次数: 6
摘要
简介:现代影像引导活检路径在诊断中心极大地改进了男性与疑似前列腺癌的调查。然而，从初级保健的转诊标准仍然是基于历史前列腺特异性抗原(PSA)截止和年龄参考阈值。在这里，我们测试了更好的当代途径和活检方法是否提高了PSA转诊阈值的预测实用价值。方法:评估PSA转诊阈值，年龄参考范围和PSA密度(PSAd)在检测临床意义的前列腺癌(csPCa -组织学上大于或小于2级组)中的阳性预测值(PPV)。分析来自三个诊断中心的男性的数据，这些中心使用多参数磁共振成像(mpMRI)指导的前列腺活检进行疾病特征。研究结果在一个单独的多中心队列中得到验证。结果:来自2767名男性的数据被纳入本研究。中位年龄、PSA和PSAd分别为66.4岁、7.3 ng/mL和0.1 ng/mL2。活检检出csPCa的占38.7%。PSA的总体曲线下面积(AUC)为0.68，与历史表现相似。小于3 ng/mL的PSA阈值具有40.3%的PPV，但这是年龄依赖性的(PPV:分别在50-59岁，60-69岁和小于70岁的男性中为24.8%，32.7%和56.8%)。不同的PSA临界值和年龄参考范围均未能表现出更好的表现。与PSA相比，PSAd改善了AUC (0.78 vs 0.68, p < 0.0001)和PPV。小于或等于3 ng/mL的PSAd的PPV为48.2%，阴性预测值(NPV)与小于或等于3 ng/mL的PSA相似，并且优于PSA年龄参考范围。这种改善的表现在一个单独的多中心队列(n = 541)中得到了再现。结论:引入基于mri的图像引导活检路径似乎不会改变PSA诊断测试特征以阳性检测csPCa。我们发现PSA年龄参考范围没有附加价值，而PSAd为所有年龄组提供了更好的PPV和单个临床有用阈值(大于或等于0.10)的潜力。证据等级:四级。
Re-evaluating the diagnostic efficacy of PSA as a referral test to detect clinically significant prostate cancer in contemporary MRI-based image-guided biopsy pathways.
Introduction: Modern image-guided biopsy pathways at diagnostic centres have greatly refined the investigations of men referred with suspected prostate cancer. However, the referral criteria from primary care are still based on historical prostate-specific antigen (PSA) cut-offs and age-referenced thresholds. Here, we tested whether better contemporary pathways and biopsy methods had improved the predictive utility value of PSA referral thresholds.
Methods: PSA referral thresholds, age-referenced ranges and PSA density (PSAd) were assessed for positive predictive value (PPV) in detection of clinically significant prostate cancer (csPCa - histological ⩾ Grade Group 2). Data were analysed from men referred to three diagnostics centres who used multi-parametric magnetic resonance imaging (mpMRI)-guided prostate biopsies for disease characterisation. Findings were validated in a separate multicentre cohort. Results: Data from 2767 men were included in this study. The median age, PSA and PSAd were 66.4 years, 7.3 ng/mL and 0.1 ng/mL2, respectively. Biopsy detected csPCa was found in 38.7%. The overall area under the curve (AUC) for PSA was 0.68 which is similar to historical performance. A PSA threshold of ⩾ 3 ng/mL had a PPV of 40.3%, but this was age dependent (PPV: 24.8%, 32.7% and 56.8% in men 50-59 years, 60-69 years and ⩾ 70 years, respectively). Different PSA cut-offs and age-reference ranges failed to demonstrate better performance. PSAd demonstrated improved AUC (0.78 vs 0.68, p < 0.0001) and improved PPV compared to PSA. A PSAd of ⩾ 0.10 had a PPV of 48.2% and similar negative predictive value (NPV) to PSA ⩾ 3 ng/mL and out-performed PSA age-reference ranges. This improved performance was recapitulated in a separate multi-centre cohort (n = 541).
Conclusion: The introduction of MRI-based image-guided biopsy pathways does not appear to have altered PSA diagnostic test characteristics to positively detect csPCa. We find no added value to PSA age-referenced ranges, while PSAd offers better PPV and the potential for a single clinically useful threshold (⩾0.10) for all age groups.
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