ObjectiveTo investigate the safety and cancer control of a novel bioabsorbable, low‐dose rate brachytherapy device, CivaSheet® (CivaTech Oncology Inc., Durham, NC, USA), in combination with radical prostatectomy (RP) with or without adjuvant external beam radiation therapy (EBRT) for the management of prostate cancer (PCa).Patients and MethodsThis is an initial, single‐centre experience, two‐dose level, two‐stage study conducted on patients with intermediate‐ and high‐risk PCa. The CivaSheet was implanted during RP, followed by adjuvant EBRT in patients with adverse pathological features. Toxicities and peri‐ and postoperative complications were assessed. Biochemical recurrence (BCR) at the 6‐month follow‐up after EBRT was also evaluated.ResultsSix patients were enrolled, with a median (range) age of 56 (53–71) years. No intraoperative complications occurred. No dose‐limiting toxicities were observed at a maximum tested dose of 75 Gy. BCR occurred in one patient at 6 months, while another patient had residual disease and metastasis at 6 months. All patients reported having postoperative erectile dysfunction and one patient experienced urinary incontinence after EBRT.ConclusionsThis study demonstrated the feasibility and safety of CivaSheet combined with RP and adjuvant EBRT for high‐risk PCa. The short‐term toxicity profile was well‐tolerated, supporting further prospective evaluation with clinical trials.

中文翻译：

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新型生物可吸收、低剂量率近距离放射治疗装置 （CivaSheet®） 联合根治性前列腺切除术和辅助外照射治疗前列腺癌


目的探讨新型生物可吸收、低剂量率近距离放射治疗装置 CivaSheet® （CivaTech Oncology Inc.， Durham， NC， USA） 联合根治性前列腺切除术 （RP） 联合或不联合辅助外照射放射治疗 （EBRT） 的安全性和癌症控制前列腺癌 （PCa）。患者和方法这是一项对中高危 PCa 患者进行的初始、单中心体验、双剂量水平、两阶段研究。在 RP 期间植入 CivaSheet，然后在具有不良病理特征的患者中进行辅助 EBRT。评估毒性以及围手术期和术后并发症。还评估了 EBRT 后 6 个月随访时的生化复发 （BCR）。结果纳入 6 例患者，中位 （范围） 年龄为 56 （53-71） 岁。未发生术中并发症。在最大测试剂量为 75 Gy 时未观察到剂量限制性毒性。1 例患者在 6 个月时发生 BCR，而另一例患者在 6 个月时有残留病灶和转移。所有患者均报告术后勃起功能障碍，1 例患者在 EBRT 后出现尿失禁。结论本研究证明了 CivaSheet 联合 RP 和辅助 EBRT 治疗高危 PCa 的可行性和安全性。短期毒性特征耐受性良好，支持通过临床试验进行进一步的前瞻性评估。