背景:寡转移前列腺癌(OMPC)的最佳治疗仍在进行中。越来越多的证据证明了根治性前列腺切除术和局部或转移导向放疗对寡转移患者的安全性和可行性。该试验的目的是证明转移定向新辅助放疗(naRT)和新辅助雄激素剥夺疗法(naADT)以及机器人辅助前列腺癌根治术(RARP)治疗OMPC的安全性和可行性。
方法:本研究将作为前瞻性,开放标签,剂量递增,I/II期临床试验。患有寡转移性PCa的患者将接受1个月的naADT,其次是转移定向放疗和腹部或盆腔放疗。然后,根治性前列腺切除术将在放疗后4-8周的间隔进行,ADT将持续2年。研究的主要终点是安全性,由不良事件通用术语标准(CTCAE)5.0分级量表评估,和围手术期疾病,由Clavien-Dindo分类系统评估。次要终点包括阳性手术切缘(pSM),生化无复发生存率(bPFS),放射学无进展生存期(RPFS),术后尿失禁,和生活质量(QoL)参数。
结论:OMPC的最佳治疗仍在进行中,促使研究针对该患者人群的新型多模态治疗方案。传统上,前列腺癌根治术已被推荐为局部前列腺癌的标准治疗方法之一。但根据NCCN和EAU指南的建议,适应症多年来有所增加。已经在一些OMPC患者中心进行了RP,但是它的价值还没有定论,显示并发症风险升高和生存获益有限。新辅助放疗已被证明在结直肠癌中安全有效,乳腺癌和其他各种类型的恶性肿瘤,在减少转移性干细胞活性方面显示出潜在的优势,提供临床降级,并降低潜在的术中风险。现有的试验表明,naRT对高风险和局部晚期前列腺癌具有良好的耐受性。在这项研究中,我们希望进一步确定泌尿生殖系统的最佳照射剂量和患者耐受性,3+3剂量递增设计的胃肠道和全身毒性;可以在RP后获得最终病理以进一步确定治疗反应和后续治疗计划。
背景:中国临床试验注册中心,ChiCTR1900025743。http://www。chictr.org.cn/showprojen.aspx?proj=43065。
BACKGROUND: The optimal treatment for
oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to demonstrate the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) for treating OMPC.
METHODS: The present
study will be conducted as a prospective, open-label, dose-escalation, phase I/II clinical
trial. The patients with
oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 4-8 weeks after radiotherapy, and ADT will be continued for 2 years. The primary endpoints of the
study are safety profiles, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0 grading scale, and perioperativemorbidities, assessed by the Clavien-Dindo classification system. The secondary endpoints include positive surgical margin (pSM), biochemical recurrence-free survival (bPFS), radiological progression-free survival (RPFS), postoperative continence, and quality of life (QoL) parameters.
CONCLUSIONS: The optimal treatment for OMPC is still on its way, prompting investigation for novel multimodality treatment protocol for this patient population. Traditionally, radical prostatectomy has been recommended as one of the standard therapies for localized prostate cancer, but indications have expanded over the years as recommended by NCCN and EAU guidelines. RP has been carried out in some centres for OMPC patients, but its value has been inconclusive, showing elevated complication risks and limited survival benefit. Neoadjuvant radiotherapy has been proven safe and effective in colorectal cancer, breast cancer and other various types of malignant tumors, showing potential advantages in terms of reducing metastatic stem-cell activity, providing clinical downstaging, and reducing potential intraoperative risks. Existing trials have shown that naRT is well tolerated for high-risk and locally-advanced prostate cancer. In this study, we hope to further determine the optimal irradiation dose and patient tolerance for genitourinary, gastrointestinal and systemic toxicities with the design of 3+3 dose escalation; also, final pathology can be obtained following RP to further determine treatment response and follow-up treatment plans.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR1900025743. http://www.chictr.org.cn/showprojen.aspx?proj=43065.