Impact of new generation hormono-therapy on cognitive functions in elderly patients treated for a metastatic prostate cancer - COG-PRO

Centre François Baclesse0 个研究点目标入组 222 人开始时间: 2016年10月10日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•For the group of patients of interest -:
•-Patient must have a metastatic castration-resistant prostate cancer (CRPCa)
•-Patient must be 70 years and more
•-Patient must have not received chemotherapy,
•-Patient must have been already treated with first generation of ADT (androgen deprivation therapy)
•-Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale - VAS = 3)
•-Patient must be candidate for a treatment by a new generation hormono-therapy (with abiraterone acetate or enzalutamide), in combination with ADT
•For control group of patients :
•-Patient with metastatic prostate cancer without resistance to castration
•-Patient must be 70 years and more
•-Patient must have not received chemotherapy,
•-Patient must have already started the first generation of ADT at least since 3 months
•For the control group of healthy volunteers:
•-No history of cancer,
•-70-year old or more,
•-Health status consistent with the participation to the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 222

•For all participants (group of patients of interest, control group of patients and group of healthy volunteers):
•-Neurological history (neurological sequelae of: traumatic brain injury, stroke, multiple sclerosis, epilepsy, neuro-degenerative disease…)
•-Known evolutive psychiatric disorder
•-Heavy drinking
•-Assessed to be unable or unwilling to comply with the requirements of the protocol

发起方

Centre François Baclesse