University of Chicago Pritzker School of Medicine, Chicago, Illinois.
Department of Urology, Northwestern Medicine, Chicago, Illinois.
J Urol. 2021 Mar;205(3):718-724. doi: 10.1097/JU.0000000000001453. Epub 2020 Oct 26.
The Prostate Health Index is validated for prostate cancer detection but has not been well validated for Gleason grade group 2-5 prostate cancer detection in Black men. We hypothesize that the Prostate Health Index has greater accuracy than prostate specific antigen for detection of Gleason grade group 2-5 prostate cancer. We estimated probability of overall and Gleason grade group 2-5 prostate cancer across previously established Prostate Health Index ranges and identified Prostate Health Index cutoffs that maximize specificity for Gleason grade group 2-5 prostate cancer with sensitivity >90%.
We recruited a "cancer-free" Black control cohort (135 patients) and a cohort of biopsy naïve Black men (158) biopsied for elevated prostate specific antigen. Descriptive statistics compared the prostate cancer cases and controls and the frequency of Gleason grade group 2-5 prostate cancer across Prostate Health Index scores. Receiver operating characteristics compared the discrimination of prostate specific antigen, Prostate Health Index and other prostate specific antigen related biomarkers. Sensitivity and specificity for Gleason grade group 2-5 prostate cancer detection were assessed at prostate specific antigen and Prostate Health Index thresholds alone and in series.
Of biopsied subjects 32.9% had Gleason grade group 2-5 prostate cancer. In Blacks with prostate specific antigen from 4.0-10.0 ng/ml, Prostate Health Index and prostate specific antigen had similar discrimination for Gleason grade group 2-5 prostate cancer (0.63 vs 0.57, p=0.27). In Blacks with prostate specific antigen ≤10.0, a threshold of prostate specific antigen ≥4.0 had 90.4% sensitivity for Gleason grade group 2-5 prostate cancer; a threshold of prostate specific antigen ≥4.0 with Prostate Health Index ≥35.0 in series avoided unnecessary biopsy in 33.0% of men but missed 17.3% of Gleason grade group 2-5 prostate cancer. Prostate specific antigen ≥4.0 with Prostate Health Index ≥28.0 in series spared biopsy in 17.9%, while maintaining 90.4% sensitivity of Gleason grade group 2-5 prostate cancer.
The Prostate Health Index has moderate accuracy in detecting Gleason grade group 2-5 prostate cancer in Blacks, but Prostate Health Index ≥28.0 can be safely used to avoid some unnecessary biopsies in Blacks.
前列腺健康指数(Prostate Health Index,简称 PHI)已被验证可用于前列腺癌的检测,但尚未在黑人男性中针对 Gleason 分级组 2-5 前列腺癌进行充分验证。我们假设 PHI 比前列腺特异性抗原(prostate specific antigen,简称 PSA)更能准确检测 Gleason 分级组 2-5 前列腺癌。我们估计了在先前建立的 PHI 范围内,总体和 Gleason 分级组 2-5 前列腺癌的概率,并确定了 PHI 截断值,以在保持 >90%灵敏度的情况下,最大限度地提高对 Gleason 分级组 2-5 前列腺癌的特异性。
我们招募了一个“无癌”黑人对照组(135 例患者)和一个未经活检的黑人男性队列(158 例),这些男性因 PSA 升高而接受活检。描述性统计比较了前列腺癌病例和对照组以及 PHI 评分的 Gleason 分级组 2-5 前列腺癌的频率。接受者操作特征(receiver operating characteristic,简称 ROC)比较了 PSA、PHI 和其他与 PSA 相关的生物标志物的鉴别能力。仅使用 PSA 和 PHI 阈值以及同时使用 PSA 和 PHI 阈值在系列中评估了对 Gleason 分级组 2-5 前列腺癌检测的灵敏度和特异性。
在接受活检的受试者中,32.9%患有 Gleason 分级组 2-5 前列腺癌。在 PSA 为 4.0-10.0ng/ml 的黑人中,PHI 和 PSA 对 Gleason 分级组 2-5 前列腺癌的鉴别能力相似(0.63 比 0.57,p=0.27)。在 PSA ≤10.0ng/ml 的黑人中,PSA≥4.0ng/ml 的阈值对 Gleason 分级组 2-5 前列腺癌具有 90.4%的灵敏度;PSA≥4.0ng/ml 与 PHI≥35.0ng/ml 联合使用可避免 33.0%男性的不必要活检,但漏诊 17.3%的 Gleason 分级组 2-5 前列腺癌。PSA≥4.0ng/ml 与 PHI≥28.0ng/ml 联合使用可避免 17.9%的活检,同时保持 Gleason 分级组 2-5 前列腺癌 90.4%的灵敏度。
PHI 对黑人的 Gleason 分级组 2-5 前列腺癌具有中等准确性,但 PHI≥28.0 可安全用于避免黑人中一些不必要的活检。