Department of Radiation Oncology and Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.
Department of Medical Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, 1650 Orleans Street, CRB1 Rm 1M45, Baltimore, MD, 21231, USA.
BMC Cancer. 2019 Jun 13;19(1):572. doi: 10.1186/s12885-019-5805-z.
In 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.
METHODS/DESIGN: This is a randomized, double-blind, phase II, prospective, multicenter study in adult males with biochemically recurrent prostate cancer following radical prostatectomy. Following registration, enzalutamide 160 mg or placebo by mouth (PO) once daily will be administered for 6 months. Following two months of study drug, external beam radiotherapy to 66.6-70.2 Gray (Gy) will be administered to the prostate bed over 7-8 weeks while continuing daily placebo/enzalutamide. This is followed by two additional months of placebo/enzalutamide.
The SALV-ENZA trial is the first phase II placebo-controlled double-blinded randomized study to test SRT in combination with a next generation androgen receptor antagonist in men with high-risk recurrent prostate cancer after radical prostatectomy. The primary hypothesis of this study is that clinical outcomes will be improved by the addition of enzalutamide compared to standard-of-care SRT alone and pave the path for phase III evaluation of this combination.
ClinicaltTrials.gov Identifier: NCT02203695 Date of Registration: 06/16/2014. Date of First Participant Enrollment: 04/16/2015.
对于根治性前列腺切除术后 PSA 升高的男性患者，挽救性放疗（SRT）提供了治愈的第二次机会。为了提高前列腺肿瘤的控制率，可以将激素治疗与 SRT 联合使用，尽管会伴随更高的治疗副作用发生率。这项试验研究了使用具有良好副作用特征的更有效的抗雄激素药物联合 SRT 的疗效。恩扎卢胺是一种新一代的选择性雄激素受体拮抗剂，已被美国食品和药物管理局批准用于治疗转移性去势抵抗性前列腺癌（CRPC），在与雄激素剥夺治疗联合使用时已显示出可提高总生存率。本研究的主要目的是评估联合 SRT 和恩扎卢胺治疗在 PSA 无进展方面的疗效。次要目标包括评估放射野内局部复发时间、无转移生存时间以及通过不良事件的频率和严重程度确定的安全性。
方法/设计：这是一项在根治性前列腺切除术后生化复发的成年男性中进行的随机、双盲、二期、前瞻性、多中心研究。登记后，患者将口服恩扎卢胺 160mg 或安慰剂，每日一次，持续 6 个月。在研究药物使用两个月后，将对前列腺床进行 66.6-70.2Gy 的外照射放疗，持续 7-8 周，同时继续每日给予安慰剂/恩扎卢胺。然后再给予两个月的安慰剂/恩扎卢胺。
SALV-ENZA 试验是第一项测试 SRT 联合下一代雄激素受体拮抗剂在根治性前列腺切除术后高危复发性前列腺癌男性中的二期安慰剂对照双盲随机研究。该研究的主要假设是，与标准 SRT 治疗相比，添加恩扎卢胺将改善临床结果，并为该联合治疗的三期评估铺平道路。
Clinicaltrials.gov 标识符：NCT02203695 注册日期：2014 年 6 月 16 日。首例参与者入组日期：2015 年 4 月 16 日。
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