Muscle mass is important for metastatic prostate cancer survival and quality of life (QoL). The backbone of treatment for men with metastatic castration sensitive prostate cancer (mCSPC) is androgen deprivation therapy (ADT) with an androgen signaling inhibitor. ADT is an effective cancer treatment, but it facilitates significant declines in muscle mass and adverse health outcomes important to mCSPC survivors, such as fatigue, and reductions in physical function, independence, insulin sensitivity, and QoL. In non-metastatic CSPC survivors, resistance training (RT) preserves muscle mass and improves these related health outcomes, but the biggest barrier to RT in CSPC survivors of all stages is fatigue. Creatine monohydrate supplementation coupled with RT (Cr + RT) may address this barrier since creatine plays a critical role in energy metabolism. Cr + RT in cancer-free older adults and other clinical populations improves muscle mass and related health outcomes. Evidence also suggests that creatine supplementation can complement cancer treatment. Thus, Cr + RT is a strategy that addresses gaps in survivorship needs of people with mCSPC. The purpose of this parallel, double-blind randomized controlled trial is to test the effects of 52-weeks of Cr + RT compared with placebo (PLA) and RT (PLA + RT) on muscle mass, other related health outcomes, and markers of cancer progression. We will carry out this trial with our team’s established, effective, home-based, telehealth RT program in 200 mCSPC survivors receiving ADT, and evaluate outcomes at baseline, 24-, and 52-weeks. RT will occur twice weekly with elastic resistance bands, and an established creatine supplementation protocol will be used for supplementation delivery. Our approach addresses a major facilitator to RT in mCSPC survivors, a home-based RT program, while utilizing a supervised model for safety. Findings will improve delivery of comprehensive survivorship care by providing a multicomponent, patient-centered lifestyle strategy to preserve muscle mass, improve health outcomes, and complement cancer treatment (NCT06112990).

中文翻译：

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肌酸补充和阻力训练可保持肌肉质量并减缓癌症进展 (CREATINE-52)：双盲随机对照试验方案

肌肉质量对于转移性前列腺癌的生存和生活质量 (QoL) 很重要。治疗患有转移性去势敏感前列腺癌 (mCSPC) 的男性的主要方法是使用雄激素信号抑制剂进行雄激素剥夺疗法 (ADT)。 ADT 是一种有效的癌症治疗方法，但它会导致肌肉质量显着下降，并导致对 mCSPC 幸存者重要的不良健康后果，例如疲劳以及身体功能、独立性、胰岛素敏感性和生活质量的下降。在非转移性 CSPC 幸存者中，阻力训练 (RT) 可以保留肌肉质量并改善这些相关的健康结果，但所有阶段的 CSPC 幸存者进行 RT 的最大障碍是疲劳。补充一水肌酸与 RT (Cr + RT) 相结合可能会解决这一障碍，因为肌酸在能量代谢中发挥着关键作用。 Cr + RT 在无癌老年人和其他临床人群中可以改善肌肉质量和相关健康结果。有证据还表明，补充肌酸可以补充癌症治疗。因此，Cr + RT 是一种解决 mCSPC 患者生存需求差距的策略。这项平行、双盲随机对照试验的目的是测试 52 周的 Cr + RT 与安慰剂 (PLA) 和 RT (PLA + RT) 相比对肌肉质量、其他相关健康结果和标志物的影响。癌症进展。我们将利用我们团队已建立的、有效的、以家庭为基础的远程医疗 RT 计划，在 200 名接受 ADT 的 mCSPC 幸存者中开展这项试验，并评估基线、24 周和 52 周的结果。 RT 将每周进行两次，使用弹性阻力带，并且将使用既定的肌酸补充方案来进行补充。我们的方法解决了 mCSPC 幸存者 RT 的主要促进因素，即基于家庭的 RT 计划，同时利用安全监督模型。研究结果将通过提供多成分、以患者为中心的生活方式策略来保持肌肉质量、改善健康结果并补充癌症治疗，从而改善综合生存护理的提供（NCT06112990）。