INSERM, U1086 ANTICIPE, Normandie University, UNICAEN, 14076, Caen, France.
Clinical Research Department, Centre François Baclesse, 14076, Caen, France.
BMC Cancer. 2017 Aug 16;17(1):549. doi: 10.1186/s12885-017-3534-8.
New generation hormone-therapies (NGHT) targeting the androgen signalling pathway are nowadays proposed to elderly patients with metastatic castration-resistant prostate cancer (CRPCa). The impact of these treatments on cognitive function has never been evaluated whereas cognitive impairment may have an impact on the autonomy and the treatment adherence. The aim of this study is to prospectively assess the incidence of cognitive impairment in elderly men after treatment by NGHT for a metastatic CRPCa.
METHODS/DESIGN: The Cog-Pro study is a multicentre longitudinal study including CRPCa patients ≥70 years old treated with NGHT (n = 134), control metastatic prostate cancer patients without castration resistance treated with first generation androgen deprivation therapy (n = 55), and healthy participants (n = 33), matched on age and education. Cognitive, geriatric and quality of life assessment and biological tests will be performed at baseline, 3, 6 and 12 months after start of the treatment (inclusion time). The primary endpoint is the proportion of elderly patients receiving a NGHT who will experience a decline in cognitive performances within 3 months after study enrollment. Secondary endpoints concern: autonomy, quality of life, anxiety, depression, cognitive reserve, adherence to hormone-therapy, comparison of the cognitive impact of 2 different NGHT (abiraterone acetate and enzalutamide), impact of co-morbidities and biological assessments.
Evaluating, understanding and analyzing the incidence, severity of cognitive impairments and their impact on quality of life, autonomy and adherence in this group of patients with advanced disease is a challenge. This study should help to improve cancer care of elderly patients and secure the use of oral treatments as the risk of non-observance does exist. Our results will provide up-to date information for patients and caregivers on impact of these treatments on cognitive function in order to help the physicians in the choice of the treatment.
NCT02907372 , registered: July 26, 2016.
目前针对转移性去势抵抗性前列腺癌（CRPCa）患者，新一代靶向雄激素信号通路的激素疗法（NGHT）被提议用于老年患者。这些治疗方法对认知功能的影响从未被评估过，而认知障碍可能会影响患者的自主性和治疗依从性。本研究旨在前瞻性评估新激素治疗方案治疗转移性 CRPCa 后老年男性认知障碍的发生率。
方法/设计：Cog-Pro 研究是一项多中心纵向研究，纳入了 134 名年龄≥70 岁接受 NGHT 治疗的 CRPCa 患者、55 名未接受去势抵抗的第一代雄激素剥夺治疗的转移性前列腺癌对照患者以及 33 名健康对照者（年龄和教育程度相匹配）。在基线、治疗开始后 3、6 和 12 个月（纳入时间）进行认知、老年和生活质量评估以及生物学检测。主要终点是在研究入组后 3 个月内，接受 NGHT 治疗的老年患者中，出现认知功能下降的比例。次要终点包括：自主性、生活质量、焦虑、抑郁、认知储备、激素治疗依从性、两种不同 NGHT（醋酸阿比特龙和恩扎卢胺）的认知影响比较、合并症的影响和生物学评估。
评估、理解和分析这组晚期疾病患者认知障碍的发生率、严重程度及其对生活质量、自主性和依从性的影响是一项挑战。这项研究应该有助于改善老年患者的癌症护理，并确保口服治疗的应用，因为确实存在不遵医嘱的风险。我们的研究结果将为患者和护理人员提供有关这些治疗对认知功能影响的最新信息，以帮助医生选择治疗方案。
NCT02907372，注册日期：2016 年 7 月 26 日。
