New generations of hormone-therapies targeting the androgen signalling axe (NGH) are nowadays proposed to elderly patients with metastatic castration-resistant prostate cancer (CRPCa). The impact of these treatments on cognitive functions has never been evaluated whereas cognitive impairment may have an impact on the autonomy and the adherence of the treatment. The aim of this study is to prospectively assess the incidence of cognitive impairment in elderly men after treatment by NGH for a metastatic CRPCa.
The Cog-Pro study is a multicentre longitudinal study including patients > 70 years treated with NGH (n = 134), control patients treated with first generation of androgen deprivation therapy (n = 55) and healthy subjects (n = 33). Cognitive tests, questionnaires and biological tests are performed at baseline, 3, 6 and 12 months after the start of treatment. The primary endpoint is the proportion of elderly patients receiving the NGH who will experience a decline in cognitive performances within 3 months after inclusion. Secondary endpoints include autonomy, quality of life, anxiety, depression, cognitive reserve, adherence to hormone-therapy, comparison of the 2 new agents (abiraterone acetate and enzalutamide), impact of co-morbidities and biological assessments. Our results will provide up-to date information for patients and caregivers on impact of NGH on cognitive functions in order to develop some strategies to help them. This study should help to improve cancer care of metastatic CRPCa elderly patients.
Clinical trial identification
Legal entity responsible for the study
Pr Florence Joly
Institut National du Cancer (InCA, France)
All authors have declared no conflicts of interest.