IMPORTANCE Men with prostate cancer who are undergoing active surveillance are at an increased risk of cardiovascular death and disease progression. Exercise has been shown to improve cardiorespiratory fitness, physical functioning, body composition, fatigue, and quality of life during and after treatment; however, to date only 1 exercise study has been conducted in this clinical setting. OBJECTIVE To examine the effects of exercise on cardiorespiratory fitness and biochemical progression in men with prostate cancer who were undergoing active surveillance. DESIGN, SETTING, AND PARTICIPANTS The Exercise During Active Surveillance for Prostate Cancer (ERASE) trial was a single-center, 2-group, phase 2 randomized clinical trial conducted at the University of Alberta, Edmonton, Canada. Eligible patients were recruited from July 24, 2018, to February 5, 2020. Participants were adult men who were diagnosed with localized very low risk to favorable intermediate risk prostate cancer and undergoing active surveillance. They were randomized to either the high-intensity interval training (HIIT) group or usual care group. All statistical analyses were based on the intention-to-treat principle. INTERVENTIONS The HIIT group was asked to complete 12 weeks of thrice-weekly, supervised aerobic sessions on a treadmill at 85% to 95% of peak oxygen consumption (V̇o2). The usual care group maintained their normal exercise levels. MAIN OUTCOMES AND MEASURES The primary outcome was peak V̇o2, which was assessed as the highest value of oxygen uptake during a graded exercise test using a modified Bruce protocol. Secondary and exploratory outcomes were indicators of biochemical progression of prostate cancer, including prostate-specific antigen (PSA) level and PSA kinetics, and growth of prostate cancer cell line LNCaP. RESULTS A total of 52 male patients, with a mean (SD) age of 63.4 (7.1) years, were randomized to either the HIIT (n = 26) or usual care (n = 26) groups. Overall, 46 of 52 participants (88%) completed the postintervention peak V̇o2 assessment, and 49 of 52 participants (94%) provided blood samples. Adherence to HIIT was 96%. The primary outcome of peak V̇o2 increased by 0.9 mL/kg/min in the HIIT group and decreased by 0.5 mL/kg/min in the usual care group (adjusted between-group mean difference (1.6 mL/kg/min; 95% CI, 0.3-2.9; P = .01). Compared with the usual care group, the HIIT group experienced decreased PSA level (-1.1 μg/L; 95% CI, -2.1 to 0.0; P = .04), PSA velocity (-1.3 μg /L/y; 95% CI, -2.5 to -0.1; P = .04), and LNCaP cell growth (-0.13 optical density unit; 95% CI, -0.25 to -0.02; P = .02). No statistically significant differences were found in PSA doubling time or testosterone. CONCLUSIONS AND RELEVANCE The ERASE trial demonstrated that HIIT increased cardiorespiratory fitness levels and decreased PSA levels, PSA velocity, and prostate cancer cell growth in men with localized prostate cancer who were under active surveillance. Larger trials are warranted to determine whether such improvement translates to better longer-term clinical outcomes in this setting. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03203460.

中文翻译：

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运动对主动监测下局限性前列腺癌男性心肺健康和生化进展的影响：ERASE 随机临床试验。


重要性 接受主动监测的前列腺癌男性心血管死亡和疾病进展的风险增加。运动已被证明可以改善治疗期间和治疗后的心肺健康、身体机能、身体成分、疲劳和生活质量；然而，迄今为止，仅在该临床环境中进行了一项运动研究。目的 研究运动对接受主动监测的前列腺癌男性患者心肺健康和生化进展的影响。设计、设置和参与者前列腺癌主动监测期间的锻炼 (ERASE) 试验是一项单中心、两组、2 期随机临床试验，在加拿大埃德蒙顿阿尔伯塔大学进行。符合条件的患者于2018年7月24日至2020年2月5日期间招募。参与者是被诊断患有局部极低风险至有利中风险前列腺癌并接受主动监测的成年男性。他们被随机分为高强度间歇训练（HIIT）组或常规护理组。所有统计分析均基于意向治疗原则。干预措施 HIIT 组被要求在跑步机上以峰值耗氧量 (V̇o2) 的 85% 至 95% 完成为期 12 周的每周三次、有监督的有氧运动。常规护理组保持正常的运动水平。主要结果和措施 主要结果是峰值摄氧量，它被评估为使用修改后的布鲁斯方案进行分级运动测试期间摄氧量的最高值。 次要和探索性结果是前列腺癌生化进展的指标，包括前列腺特异性抗原 (PSA) 水平和 PSA 动力学，以及前列腺癌细胞系 LNCaP 的生长。结果 共有 52 名平均 (SD) 年龄为 63.4 (7.1) 岁的男性患者被随机分为 HIIT 组 (n = 26) 或常规护理组 (n = 26)。总体而言，52 名参与者中的 46 名 (88%) 完成了干预后峰值 V̇o2 评估，52 名参与者中的 49 名 (94%) 提供了血液样本。 HIIT 坚持率为 96%。 HIIT 组中峰值 V̇o2 的主要结果增加了 0.9 mL/kg/min，而常规护理组则降低了 0.5 mL/kg/min（调整后的组间平均差（1.6 mL/kg/min；95% CI ，0.3-2.9；P = .01），与常规护理组相比，HIIT 组的 PSA 水平降低（-1.1 μg/L；95% CI，-2.1 至 0.0；P = .04），PSA 速度（ -1.3 μg /L/y；95% CI，-2.5 至 -0.1；P = .04)，以及 LNCaP 细胞生长（-0.13 光密度单位；95% CI，-0.25 至 -0.02；P = .02）结论和相关性 ERASE 试验表明，对于处于活动状态的局限性前列腺癌患者，HIIT 可以提高心肺健康水平并降低 PSA 水平、PSA 速度和前列腺癌细胞生长。需要进行更大规模的试验来确定这种改善是否会转化为更好的长期临床结果。 试验注册 ClinicalTrials.gov 标识符：NCT03203460。