Decipher 是一种基于组织的基因组分类器 (GC)，在根治性前列腺切除术 (RP) 后作为转移的预测因子进行开发和验证。我们进行了一项前瞻性随机对照整群交叉试验，评估 Decipher 的使用，以确定其对 RP 后辅助治疗的影响。符合条件的患者在入组后 9 个月内接受了 RP、患有 pT3-4 疾病和/或手术切缘阳性以及前列腺癌-特异性抗原<0.1 ng/ml。各中心被随机分为一系列为期 3 个月的 GC 通知护理或常规护理 (UC)。向所有时期的治疗医生和患者提供前列腺癌风险评估术后 (CAPRA-S) 复发风险评分。将 GC 测试结果与单独 UC 的辅助治疗的影响进行比较。纵向评估患者报告的泌尿和性功能。共有 175 名患者入组 27 个时期的 GC，163 名患者入组 28 个时期的 UC。 RP 后 18 个月，GC 组患者平均有 9.7% 的时间接受辅助治疗，而 UC 组患者平均接受辅助治疗的时间为 8.7%（平均差 0.99%，95% 置信区间 [CI] -7.6%， 9.6%，p = 0.8）。在控制 CAPRA-S 评分的同时，较高的 GC 评分往往会导致辅助治疗的可能性增加，但无统计学意义（优势比 [OR] = GC 评分每增加 0.1 1.35，95% CI 0.98-1.85，p = 0.066）。使用反映临床使用的 GC 风险组，与低 GC 评分相比，高 GC 风险与接受辅助治疗的几率显着较高相关（OR = 6.9，95% CI 1.8, 26，p = 0.005），并根据 CAPRA 进行调整-S 分数。研究组之间患者报告的泌尿和性功能没有差异。由于肿瘤学结果尚不成熟，目前的数据无法确定 GC 检测是否能提供任何癌症控制益处。从患者报告中呈现的风险类别来看，GC 检测会影响辅助治疗的实施；然而，这些数据并未为辅助治疗环境中的 GC 检测提供具体支持。版权所有 © 2024 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。

Decipher is a tissue-based genomic classifier (GC) developed and validated in the post-radical prostatectomy (RP) setting as a predictor of metastasis. We conducted a prospective randomized controlled cluster-crossover trial assessing the use of Decipher to determine its impact on adjuvant treatment after RP.Eligible patients had undergone RP within 9 mo of enrollment, had pT3-4 disease and/or positive surgical margins, and prostate-specific antigen <0.1 ng/ml. Centers were randomized to a sequence of 3-mo periods of either GC-informed care or usual care (UC). Cancer of the Prostate Risk Assessment Postsurgical (CAPRA-S) recurrence risk scores were provided to treating physicians and patients in all periods.Impact of GC test results on adjuvant treatment were compared with UC alone. Longitudinal patient-reported urinary and sexual function was assessed. A total of 175 patients were enrolled in 27 periods with GC and 163 in 28 periods with UC. At 18 mo after RP, an average patient in the GC arm received adjuvant treatment 9.7% of the time compared with 8.7% for an average individual in the UC arm (0.99% mean difference, 95% confidence interval [CI] -7.6%, 9.6%, p = 0.8). While controlling for CAPRA-S score, higher GC scores tended to result in an increased likelihood of adjuvant treatment that was not statistically significant (odds ratio [OR] = 1.35 per 0.1 increase in GC score, 95% CI 0.98-1.85, p = 0.066). Using the GC risk groups, reflecting clinical use, a high GC risk was associated with significantly higher odds of receiving adjuvant treatment (OR = 6.9, 95% CI 1.8, 26, p = 0.005) compared with a low GC score, adjusted for CAPRA-S score. There were no differences in patient-reported urinary and sexual function between the study arms. As oncologic outcomes are immature, the present data cannot address whether GC testing provides any cancer control benefit.GC testing impacts adjuvant therapy administration when viewed through the risk categories presented in the patient report; however, these data do not provide specific support for GC testing in the adjuvant treatment setting.Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.