Cleveland Clinic, Glickman Urological and Kidney Institute, Cleveland, OH.
Cleveland Diagnostics, Inc., Cleveland, OH.
Urology. 2023 May;175:132-136. doi: 10.1016/j.urology.2023.01.037. Epub 2023 Feb 16.
To. determine the impact of 5-α reductase inhibitors or α-blockers on IsoPSA performance for the detection of actionable prostate cancer.
This is a secondary analysis of data from an institutional review board approved, prospective, multicenter(8-sites) study evaluating IsoPSA in men ≥ 50 years of age with a total PSA ≥ 4 ng/mL with planned prostate biopsy who met previously described inclusion and exclusion criteria. Analytic groups included (i)all subjects, (ii-iii)+/- 5-ARI use, (iv-v)+/- α-blocker use. The performance characteristics of IsoPSA in these groups were assessed by ROC curve, sensitivity, and specificity (SP) analysis.
A total of 1385 men were recruited with 888 men included in final analysis. Actionable prostate cancer, defined as GG2+, was identified in a total of 316 patients with 40 and 217 patients reporting 5-ARI and α-blocker use respectively. Sensitivity to detect both prostate cancer and actionable cancer was similar between patient subsets (P >.05). SP was similar between patients regardless of 5-ARI(P >.05). Increased SP was noted in patients on α-blockers(GG1+: No-α-blocker: 0.360 vs α-blocker: 0.529, P <.05; GG2+: No-α-blocker: 0.40 vs α-blocker: 0.61, P <.05). ROC analysis demonstrates that IsoPSA performance is unaffected by 5-ARI or α-blocker use for prostate cancer and actionable cancer (GG2+) detection.
The performance of IsoPSA for detecting any prostate cancer and clinically actionable prostate cancer is unaffected by commonly used medications (5-ARI and α-blockers) for symptoms of benign prostatic hyperplasia.
确定 5-α 还原酶抑制剂或 α-受体阻滞剂对 IsoPSA 检测可治疗前列腺癌的影响。
这是一项对机构审查委员会批准的、前瞻性、多中心（8 个地点）研究数据的二次分析，该研究评估了 IsoPSA 在总 PSA≥4ng/mL 且计划进行前列腺活检的年龄≥50 岁男性中的应用，这些男性符合先前描述的纳入和排除标准。分析组包括（i）所有受试者，（ii-iii）+/-5-ARI 应用，（iv-v）+/-α-受体阻滞剂应用。通过 ROC 曲线、敏感性和特异性（SP）分析评估 IsoPSA 在这些组中的性能特征。
共招募了 1385 名男性，其中 888 名男性纳入最终分析。共在 316 名患者中发现了可治疗性前列腺癌，定义为 GG2+，其中 40 名和 217 名患者分别报告使用了 5-ARI 和α-受体阻滞剂。在不同的患者亚组中，检测前列腺癌和可治疗性癌症的敏感性相似（P＞.05）。无论患者是否使用 5-ARI，SP 均相似（P＞.05）。在使用α-受体阻滞剂的患者中，SP 增加（GG1+：无-α-受体阻滞剂：0.360 比 α-受体阻滞剂：0.529，P＜.05；GG2+：无-α-受体阻滞剂：0.40 比 α-受体阻滞剂：0.61，P＜.05）。ROC 分析表明，IsoPSA 对前列腺癌和可治疗性前列腺癌（GG2+）的检测不受 5-ARI 或α-受体阻滞剂的影响。
对于治疗良性前列腺增生的常用药物（5-ARI 和α-受体阻滞剂），IsoPSA 检测任何前列腺癌和临床可治疗性前列腺癌的性能不受影响。
