首页> 美国卫生研究院文献>BMC Cancer >A phase II randomized placebo-controlled double-blind study of salvage radiation therapy plus placebo versus SRT plus enzalutamide with high-risk PSA-recurrent prostate cancer after radical prostatectomy (SALV-ENZA)
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A phase II randomized placebo-controlled double-blind study of salvage radiation therapy plus placebo versus SRT plus enzalutamide with high-risk PSA-recurrent prostate cancer after radical prostatectomy (SALV-ENZA)

机译:根治性前列腺切除术后高危PSA复发前列腺癌(SALV-ENZA)的挽救性放疗联合安慰剂与SRT联合恩杂鲁胺的II期随机安慰剂对照双盲研究

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摘要

BackgroundIn men with a rising PSA following radical prostatectomy, salvage radiation therapy (SRT) offers a second chance for cure. Hormonal therapy can be combined with SRT in order to increase prostate tumor control, albeit with associated higher rates of treatment side effects. This trial studies the effectiveness of SRT combined with hormonal therapy using a more potent anti-androgen with a favorable side effect profile. Enzalutamide, a next generation selective androgen receptor antagonist, is approved by the Food and Drug Administration for the treatment of metastatic castrate-resistant prostate cancer (CRPC) where it has been shown to improve overall survival in combination with androgen deprivation therapy. The primary objective of this study is to evaluate the efficacy of combination SRT and enzalutamide for freedom-from-PSA-progression. Secondary objectives include time to local recurrence within the radiation field, metastasis-free survival and safety as determined by frequency and severity of adverse events.
机译:背景对于前列腺癌根治术后PSA升高的男性,抢救性放射治疗(SRT)提供了第二次治愈机会。激素治疗可以与SRT结合使用,以增加对前列腺肿瘤的控制,尽管伴随有更高的治疗副作用率。该试验研究了使用更有效的抗雄激素和副作用良好的激素疗法联合SRT的有效性。 Enzalutamide是一种下一代选择性雄激素受体拮抗剂,已获得美国食品药品监督管理局(FDA)的批准,可用于治疗转移性去势抵抗性前列腺癌(CRPC),并已证明与雄激素剥夺疗法相结合可提高总体生存率。这项研究的主要目的是评估SRT和enzalutamide联合使用对摆脱PSA进展的功效。次要目标包括放疗区域内局部复发的时间,无转移生存率和安全性(由不良事件的发生频率和严重程度决定)。

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