PURPOSE Cabazitaxel has been demonstrated to improve the overall survival for men with metastatic castrate-resistant prostate cancer. The purpose of this study was to determine the maximum tolerated dose for concurrent cabazitaxel with androgen deprivation and intensity modulated radiation therapy in men with high-risk prostate cancer. METHODS AND MATERIALS Twenty men were enrolled in this institutuional review board-approved phase I clinical trial using a 3 + 3 design. Patients were followed prospectively for safety, efficacy, and health-related quality of life (Expanded Prostate Index Composite). Efficacy was assessed biochemically using the Phoenix definition. RESULTS With a median follow-up time of 56 months, the maximum tolerated dose of concurrent cabazitaxel was 6 mg/m2. The 5-year biochemical disease-free survival was 73%, despite 75% of patients having very high risk prostate cancer per the National Comprehensive Cancer Network guidelines. Four patients were unable to complete chemotherapy owing to dose-limiting toxicities (eg, rectal bleeding, diarrhea, and elevated transaminase). There was no significant minimally important difference in Expanded Prostate Index Composite patient-reported outcomes for either the urinary or bowel domains; however, there was a significant decrease in the sexual domain. CONCLUSIONS This is the first clinical trial of prostate cancer to report on the combination of cabazitaxel and radiation therapy. The maximum tolerated dose of concurrent cabazitaxel with radiation and androgen deprivation therapy was determined to be 6 mg/m2. Despite the aggressive nature of the disease, robust biochemical control was observed.

中文翻译：

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每周卡巴他赛的一期试验，同时进行强度调节的放射和雄激素剥夺疗法，以治疗高危前列腺癌。

目的已证明卡巴他赛可改善转移性去势抵抗性前列腺癌男性的总体生存率。这项研究的目的是确定患有高危前列腺癌的男性同时接受卡巴他赛联合雄激素剥夺和调强放射治疗的最大耐受剂量。方法和材料20名男性参加了该机构审查委员会批准的3 + 3设计的I期临床试验。对患者进行前瞻性的安全性，有效性和与健康相关的生活质量随访（前列腺指数综合指数）。使用Phoenix定义通过生化评估疗效。结果中位随访时间为56个月，并发卡巴他赛的最大耐受剂量为6 mg / m2。5年无生化疾病的生存率为73％，根据国家综合癌症网络指南，尽管有75％的患者患有非常高的前列腺癌风险。由于剂量限制的毒性作用（例如直肠出血，腹泻和转氨酶升高），四名患者无法完成化疗。尿液或肠区的前列腺肥大综合指数患者报告的预后没有显着的最小差异。但是，性领域明显减少。结论这是首次报告卡巴他赛与放射治疗相结合的前列腺癌临床试验。放疗和雄激素剥夺疗法同时使用卡巴他赛的最大耐受剂量确定为6 mg / m2。尽管该疾病具有侵略性，但仍观察到强有力的生化控制。