NCT02907372

Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: Male
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.

Detailed description

In this new area of multiples new treatments in advanced PCa that could be proposed to elderly patients, evaluating, understanding and analysing the incidence, severity of cognitive dysfunctions and their impact on quality of life, autonomy and adherence among this group of vulnerable patients with advanced disease is a challenge and is essential to help clinicians taking care of their patients. As the deficits may be subtle and not always related with complaints, cognitive functions need to be assessed by objective sensitive neuropsychological tests and by patient-perceived cognitive self-report questionnaire. In addition to the treatments,there is a range of potential confounders that can contribute to cognitive impairment, such as co-medications, psychological factors (e.g. anxiety or depression), fatigue, or cognitive reserve (i.e. patients with higher education, more occupational attainment, or participation in leisure activities report less clinical or cognitive changes with aging. The evaluation and the comprehension of the cognitive decline in patients treated for a cancer are complex and need a multidisciplinary approach in human sciences in strong link to clinicians and biologist researchers. Therefore, this study propose an original unique comprehensive interdisciplinary approach at the interface between public health, clinical research, psychology and biology which would have a direct impact on cancer patient care, including a consortium of neuropsychologists, oncologists and biologist researchers who are working together within the North West canceropole "cognition and cancer" program. In evaluating cognitive functions, mood, quality of life and adherence to treatments, fully in the scope of the proposal, will help to improve our knowledge in this new field of research in human health among cancer patients with a direct impact for the physicians and the patients. The strength of this project is to propose (in complement to the study conducted among patients) a comprehensive approach including an animal model with behavioural tasks as recommended by the ICCTF (International Cognition and Cancer Task Force). This study will be the first one to address the question of the impact of the novel oral hormonal agents among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.

Conditions

• Metastatic Castration-resistant Prostate Cancer (CRPCa)

Interventions

Type	Name	Description
OTHER	neuropsychologic evaluation
OTHER	oncogeriatric evaluation

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-09-20
• Last updated: 2023-01-11

Locations

6 sites across 1 country: France