大豆分离蛋白补充对根治性前列腺切除术后前列腺癌生化复发的影响：一项随机试验。
Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial.
机构信息
Department of Pathology, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.
出版信息
JAMA. 2013 Jul 10;310(2):170-8. doi: 10.1001/jama.2013.7842.
IMPORTANCE
Soy consumption has been suggested to reduce risk or recurrence of prostate cancer, but this has not been tested in a randomized trial with prostate cancer as the end point.
OBJECTIVE
To determine whether daily consumption of a soy protein isolate supplement for 2 years reduces the rate of biochemical recurrence of prostate cancer after radical prostatectomy or delays such recurrence.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind trial conducted from July 1997 to May 2010 at 7 US centers comparing daily consumption of a soy protein supplement vs placebo in 177 men at high risk of recurrence after radical prostatectomy for prostate cancer. Supplement intervention was started within 4 months after surgery and continued for up to 2 years, with prostate-specific antigen (PSA) measurements made at 2-month intervals in the first year and every 3 months thereafter.
INTERVENTION
Participants were randomized to receive a daily serving of a beverage powder containing 20 g of protein in the form of either soy protein isolate (n=87) or, as placebo, calcium caseinate (n=90).
MAIN OUTCOMES AND MEASURES
Biochemical recurrence rate of prostate cancer (defined as development of a PSA level of ≥0.07 ng/mL) over the first 2 years following randomization and time to recurrence.
RESULTS
The trial was stopped early for lack of treatment effects at a planned interim analysis with 81 evaluable participants in the intervention group and 78 in the placebo group. Overall, 28.3% of participants developed biochemical recurrence within 2 years of entering the trial (close to the a priori predicted recurrence rate of 30%). Among these, 22 (27.2%) occurred in the intervention group and 23 (29.5%) in the placebo group. The resulting hazard ratio for active treatment was 0.96 (95% CI, 0.53-1.72; log-rank P = .89). Adherence was greater than 90% and there were no apparent adverse events related to supplementation.
CONCLUSION AND RELEVANCE
Daily consumption of a beverage powder supplement containing soy protein isolate for 2 years following radical prostatectomy did not reduce biochemical recurrence of prostate cancer in men at high risk of PSA failure.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00765479.
重要性
大豆的摄入被认为可以降低前列腺癌的风险或复发，但这尚未在以前列腺癌为终点的随机试验中得到验证。
目的
确定每天服用大豆蛋白分离物补充剂 2 年是否会降低前列腺癌根治术后生化复发的速度，或延迟这种复发。
设计、地点和参与者：这是一项在美国 7 个中心进行的随机、双盲试验，比较了 177 名前列腺癌根治术后复发风险较高的男性在 4 个月内服用大豆蛋白补充剂与安慰剂的效果。补充剂干预开始于手术后，并持续 2 年，在第一年每 2 个月测量一次前列腺特异性抗原（PSA），此后每 3 个月测量一次。
干预
参与者被随机分配每天服用一种含有 20 克蛋白质的饮料粉，其中 87 人服用的是大豆蛋白分离物，90 人服用的是作为安慰剂的酪蛋白钙。
主要结果和测量指标
在随机分组后 2 年内前列腺癌的生化复发率（定义为 PSA 水平≥0.07ng/mL）以及复发时间。
结果
在计划的中期分析中，由于缺乏治疗效果，试验提前停止，干预组有 81 名可评估参与者，安慰剂组有 78 名。总的来说，2 年内有 28.3%的参与者出现生化复发（接近事先预测的 30%复发率）。其中，干预组 22 人（27.2%），安慰剂组 23 人（29.5%）。积极治疗的风险比为 0.96（95%CI，0.53-1.72；对数秩 P=0.89）。依从性大于 90%，且无明显与补充剂相关的不良反应。
结论和相关性
前列腺癌根治术后 2 年内每天服用含有大豆蛋白分离物的饮料粉补充剂，并未降低高危 PSA 失败男性的前列腺癌生化复发率。
试验注册
clinicaltrials.gov 标识符：NCT00765479。
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