文章：

接受主动监测的低风险或中风险前列腺癌患者补充发酵大豆营养品：PRAEMUNE试验结果

Nutritional Supplement with Fermented Soy in Patients Under Active Surveillance for Low-Risk or Intermediate-Risk Prostate Cancer: Results from the PRAEMUNE Trial

原文发布日期：28 October 2024

DOI: 10.3390/cancers16213634

类型: Article

开放获取: 是

英文摘要：

Background/Objectives:To investigate the effect of a fermented soy supplement during 18 months in patients under active surveillance (AS) for low-risk and selected favorable intermediate-risk prostate cancer (PCa), with an emphasis on PSA modulation.Methods:Low-risk patients with ISUP grade 1, clinical stage cT1 or cT2a, PSA < 10 ng/mL and favorable intermediate-risk patients with ISUP grade 2 (<10% pattern 4), clinical stage T2b-c, PSA 10–20 ng/mL. The primary outcome was PSA response defined as maximum PSA rise less than or equal to 0.87 ng/mL after 1 year, based on the weighted average of PSA velocity (PSAV) in previous studies in similar populations. Secondary outcomes were disease progression, adverse histology on repeat biopsy or switch to active therapy. In addition, primary and secondary outcomes with imputed data were also determined as sensitivity analyses, using Mann–Whitney U or Chi-squared tests.Results:Overall, 92 (61.3%) of 150 patients showed a PSA level response. This was more evident in ISUP 1 patients and resulted in fewer follow-up MRIs and fewer control biopsies, as well as a fewer number of positive control biopsies with statistical significance in the imputed dataset. Obtaining a PSA response was numerically associated with less initiated therapy.Conclusions:a fermented soy supplement in patients under AS for low-risk and selected favorable intermediate-risk PCa could be useful in selecting patients who may remain under AS or who may need to switch to active therapy.

摘要翻译： 

背景/目的：本研究旨在探讨发酵大豆补充剂对接受积极监测的低风险及经筛选的有利中危前列腺癌患者为期18个月的影响，重点关注其对前列腺特异性抗原的调节作用。 方法：研究对象包括国际泌尿病理学会分级1级、临床分期cT1或cT2a、PSA<10 ng/mL的低风险患者，以及ISUP分级2级（4级模式<10%）、临床分期T2b-c、PSA 10–20 ng/mL的有利中危患者。主要结局指标为PSA应答，定义为基于既往同类人群研究中PSA变化速度的加权平均值，治疗1年后PSA最大升高值≤0.87 ng/mL。次要结局包括疾病进展、重复活检发现不良病理特征或转为积极治疗。此外，采用曼-惠特尼U检验或卡方检验对包含估算数据的主要和次要结局进行敏感性分析。 结果：在150例患者中，共有92例（61.3%）出现PSA水平应答。这一现象在ISUP 1级患者中更为显著，并导致随访MRI检查次数减少、控制性活检次数降低，且在估算数据集中具有统计学显著意义的阳性控制活检数量减少。获得PSA应答在数值上与较低的治疗启动率相关。 结论：对于接受积极监测的低风险及经筛选的有利中危前列腺癌患者，发酵大豆补充剂可能有助于甄别适合继续接受积极监测或需要转为积极治疗的患者群体。

原文链接：

Nutritional Supplement with Fermented Soy in Patients Under Active Surveillance for Low-Risk or Intermediate-Risk Prostate Cancer: Results from the PRAEMUNE Trial