Carbunaru Samuel, Stinson James, Babajide Rilwan, Hollowell Courtney M P, Yang Ximing, Sekosan Marin, Ferrer Karen, Kajdacsy-Balla Andre, Abelleira Josephine, Ruden Maria, King-Lee Patrice, Dalton Daniel P, Casalino David D, Kittles Rick A, Gann Peter H, Schaeffer Edward M, Murphy Adam B
Department of Urology Northwestern University Feinberg School of Medicine Chicago IL USA.
Division of Urology Cook County Health and Hospitals System Chicago IL USA.
BJUI Compass. 2021 Jun 15;2(6):370-376. doi: 10.1002/bco2.91. eCollection 2021 Nov.
To compare Prostate Health Index (PHI) and prostate-specific antigen (PSA) density as secondary tests after multiparametric magnetic resonance imaging (mpMRI) in improving the detection accuracy of Gleason grade group (GG) 2-5 prostate cancer (PCa) and in decreasing unnecessary biopsies in a multiethnic biopsy-naïve population.
From February 2017 to February 2020, we recruited consecutive biopsy-naïve men in participating urology clinics for elevated PSA levels. They all had a PHI score, mpMRI, and prostate biopsy. Experienced genitourinary radiologists read all mpMRI studies based on PIRADS version 2.0. Logistic regression models were used to generate receiver operating characteristic curves. Models were tested for effect modification between Race (Black vs White) and both PHI and PSA density, and Race and PIRADS to determine if race impacted their prediction accuracy. Sensitivity, specificity, and predictive values of PHI and PSA density thresholds were calculated by PIRADS scores. The primary outcome was GG2-5 PCa, that is, Gleason score ≥3 + 4.
The study included 143 men, of which 65 (45.5%) were self-reported Black. Median age was 62.0 years and 55 men (38.4%) had GG2-5 PCa. Overall, 18.1% had PIRADS 1-2, 32.9% had PIRADS 3, and 49.0% had PIRADS 4-5. For the binary logistic regressions, the interactions between PIRADS and Race ( = .08), Log (PHI) and Race ( = .17), and Log (PSA density) and Race ( = .42) were not statistically significant. Within PIRADS 3 lesions, a PHI ≥49 prevented unnecessary biopsies in 55% of men and missed no GG2-5 PCa, yielding a negative predictive value of 100%. There was no reliable PHI or PSA density threshold to avoid PCa biopsies in PIRADS 1-2 or 4-5.
PHI and PSA density can be used after mpMRI to improve the detection of GG2-5 PCa in a biopsy-naïve cohort. PHI may be superior to PSA density in PIRADS 3 lesions by avoiding 55% of unnecessary biopsies. Using both PHI and PSA density in series may further increase specificity and lead to fewer unnecessary biopsies, but further larger studies are warranted to determine the optimal threshold of each biomarker.
比较前列腺健康指数(PHI)和前列腺特异性抗原(PSA)密度作为多参数磁共振成像(mpMRI)后的二次检测方法,在提高多民族未接受过活检人群中 Gleason 分级组(GG)2 - 5 前列腺癌(PCa)检测准确性及减少不必要活检方面的效果。
2017 年 2 月至 2020 年 2 月,我们在参与研究的泌尿外科诊所连续招募 PSA 水平升高且未接受过活检的男性。他们均接受了 PHI 评分、mpMRI 和前列腺活检。经验丰富的泌尿生殖放射科医生根据 PIRADS 2.0 版解读所有 mpMRI 检查结果。采用逻辑回归模型生成受试者操作特征曲线。对种族(黑人与白人)与 PHI 和 PSA 密度之间以及种族与 PIRADS 之间的效应修饰进行模型检验,以确定种族是否影响它们的预测准确性。根据 PIRADS 评分计算 PHI 和 PSA 密度阈值的敏感性、特异性和预测值。主要结局为 GG2 - 5 PCa,即 Gleason 评分≥3 + 4。
该研究纳入 143 名男性,其中 65 名(45.5%)自我报告为黑人。中位年龄为 62.0 岁,55 名男性(38.4%)患有 GG2 - 5 PCa。总体而言,18.1%的人 PIRADS 评分为 1 - 2,32.9%的人 PIRADS 评分为 3,49.0%的人 PIRADS 评分为 4 - 5。对于二元逻辑回归,PIRADS 与种族(P = 0.08)、Log(PHI)与种族(P = 0.17)以及 Log(PSA 密度)与种族(P = 0.42)之间的交互作用无统计学意义。在 PIRADS 3 级病变中,PHI≥49 可使 55%的男性避免不必要的活检,且未漏诊 GG2 - 5 PCa,阴性预测值为 100%。在 PIRADS 1 - 2 级或 4 - 5 级病变中,没有可靠的 PHI 或 PSA 密度阈值可避免 PCa 活检。
mpMRI 后可使用 PHI 和 PSA 密度来提高未接受过活检队列中 GG2 - 5 PCa 的检测率。在 PIRADS 3 级病变中,PHI 可能优于 PSA 密度,可避免 55%的不必要活检。串联使用 PHI 和 PSA 密度可能会进一步提高特异性并减少不必要的活检,但需要进一步开展更大规模的研究来确定每个生物标志物的最佳阈值。