Division of Urologic Oncology, UC San Diego Moores Comprehensive Cancer Center, La Jolla, CA, USA.
Department of Urology, UC San Diego Health System, La Jolla, CA, USA.
BJU Int. 2018 Apr;121(4):534-539. doi: 10.1111/bju.13890. Epub 2017 May 21.
OBJECTIVE: To assess the feasibility of performing national, randomized trials of dietary interventions for localized prostate cancer. METHODS: The Men's Eating and Living (MEAL) study (CALGB 70807 [Alliance]) is a phase III clinical trial testing the efficacy of a high-vegetable diet to prevent progression in patients with prostate cancer on active surveillance (AS). Participants were randomized to a validated diet counselling intervention or to a control condition. Chi-squared and Kruskal-Wallis analyses were used to assess between-group differences at baseline. RESULTS: Between 2011 and 2015, 478 (103%) of a targeted 464 patients were randomized at 91 study sites. At baseline, the mean (sd) age was 64 (6) years and mean (sd) PSA concentration was 4.9 (2.1) ng/mL. Fifty-six (12%) participants were African-American, 17 (4%) were Hispanic/Latino, and 16 (3%) were Asian-American. There were no significant between-group differences for age (P = 0.98), race/ethnicity (P = 0.52), geographic region (P = 0.60), time since prostate cancer diagnosis (P = 0.85), PSA concentration (P = 0.96), clinical stage (T1c or T2a; P = 0.27), or Gleason sum (Gleason 6 or 3+4 = 7; P = 0.76). In a pre-planned analysis, the baseline prostate biopsy samples of the first 50 participants underwent central pathology review to confirm eligibility, with an expectation that <10% would become ineligible. One of 50 participants (2%) became ineligible. CONCLUSION: The MEAL study shows the feasibility of implementing national, multi-institutional phase III clinical trials of diet for prostate cancer and of testing interventions to prevent disease progression in AS.
目的:评估开展全国范围内、针对局限性前列腺癌的饮食干预措施的随机临床试验的可行性。
方法:Men's Eating and Living(MEAL)研究(CALGB 70807[联盟])是一项 III 期临床试验,旨在测试高蔬菜饮食预防主动监测(AS)患者前列腺癌进展的疗效。参与者被随机分配至接受验证后的饮食咨询干预组或对照组。采用卡方检验和 Kruskal-Wallis 分析比较组间基线差异。
结果:2011 年至 2015 年,在 91 个研究点,对目标 464 例患者中的 478 例(103%)进行了随机分组。基线时,平均(标准差)年龄为 64(6)岁,平均(标准差)PSA 浓度为 4.9(2.1)ng/ml。56 例(12%)参与者为非裔美国人,17 例(4%)为西班牙裔/拉丁裔,16 例(3%)为亚裔美国人。年龄(P=0.98)、种族/民族(P=0.52)、地理位置(P=0.60)、前列腺癌诊断后时间(P=0.85)、PSA 浓度(P=0.96)、临床分期(T1c 或 T2a;P=0.27)或 Gleason 总和(Gleason 6 或 3+4=7;P=0.76)方面,组间均无显著差异。在一项预先计划的分析中,前 50 例参与者的基线前列腺活检样本接受了中心病理复查以确认合格性,预计 10%以下的患者将不合格。50 例患者中有 1 例(2%)不合格。
结论:MEAL 研究表明,开展全国范围内、多机构 III 期前列腺癌饮食临床试验以及测试 AS 中预防疾病进展的干预措施是可行的。
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