Department of Urology, New York University Langone School of Medicine, New York, New York, USA.
Department of Preventive Medicine, Northwestern University, Chicago, Illinois, USA.
Cancer Med. 2023 Oct;12(19):19690-19700. doi: 10.1002/cam4.6615. Epub 2023 Oct 3.
The Oncotype Dx Genomic Prostate Score (GPS) is a 17-gene relative expression assay that predicts adverse pathology at prostatectomy. We conducted a novel randomized controlled trial to assess the impact of GPS on urologist's treatment preference for favorable risk prostate cancer (PCa): active surveillance versus active treatment (i.e., prostatectomy/radiation). This is a secondary endpoint from the ENACT trial which recruited from three Chicago hospitals from 2016 to 2019.
Ten urologists along with men with very low to favorable-intermediate risk PCa were included in the study. Participants were randomly assigned to standardized counseling with or without GPS assay. The main outcome was urologists' preference for active treatment at Visit 2 by study arm (GPS versus Control). Multivariable best-fit binary logistic regressions were constructed to identify factors independently associated with urologists' treatment preference.
Two hundred men (70% Black) were randomly assigned to either the Control (96) or GPS arm (104). At Visit 2, urologists' preference for prostatectomy/radiation almost doubled in the GPS arm to 29.3% (29) compared to 14.1% (13) in the Control arm (p = 0.01). Randomization to the GPS arm, intermediate NCCN risk level, and lower patient health literacy were predictors for urologists' preference for active treatment.
Limitations included sample size and number of urologists. In this study, we found that GPS testing reduced urologists' likelihood to prefer active surveillance.
These findings demonstrate how obtaining prognostic biomarkers that predict negative outcomes before treatment decision-making might influence urologists' preference for recommending aggressive therapy in men eligible for active surveillance.
Oncotype Dx 基因组前列腺评分（GPS）是一种 17 个基因相对表达检测方法，可预测前列腺切除术时的不良病理。我们进行了一项新的随机对照试验，以评估 GPS 对泌尿科医生治疗低危到中危前列腺癌（PCa）的偏好的影响：主动监测与积极治疗（即前列腺切除术/放疗）。这是 2016 年至 2019 年在芝加哥三家医院进行的 ENACT 试验的次要终点。
10 名泌尿科医生和低危到中危 PCa 男性参与了这项研究。参与者被随机分配到接受标准咨询或 GPS 检测。主要结局是按研究臂（GPS 与对照）评估泌尿科医生在第 2 次就诊时对积极治疗的偏好。构建多变量最佳拟合二项逻辑回归模型，以确定与泌尿科医生治疗偏好独立相关的因素。
200 名男性（70%为黑人）被随机分配至对照组（96 名）或 GPS 组（104 名）。在第 2 次就诊时，GPS 组中泌尿科医生对前列腺切除术/放疗的偏好几乎增加了一倍，达到 29.3%（29 名），而对照组为 14.1%（13 名）（p=0.01）。随机分配到 GPS 组、中间 NCCN 风险水平和较低的患者健康素养是泌尿科医生偏好积极治疗的预测因素。
研究的局限性包括样本量和泌尿科医生的数量。在这项研究中，我们发现 GPS 检测降低了泌尿科医生推荐主动监测的可能性。
这些发现表明，在治疗决策前获得预测不良结局的预后生物标志物可能会影响泌尿科医生在符合主动监测条件的男性中推荐积极治疗的偏好。
